Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-01-04 @ 6:08 AM
Study NCT ID:
NCT02793856
Status:
COMPLETED
Last Update Posted:
2021-01-12
First Post:
2016-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PD-1 Knockout Engineered T Cells for Metastatic Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': '283494287@qq.com', 'phone': '+862885423571', 'title': 'You Lu', 'organization': 'West China Hospital, Sichuan University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for 2 years.', 'description': 'Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs', 'eventGroups': [{'id': 'EG000', 'title': 'Pre-A Cohort', 'description': 'Grade 1/2 treatment-related adverse events (AEs) occurred in 2 patients.', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'A Cohort', 'description': 'Grade 1/2 treatment-related adverse events (AEs) occurred in 4 patients.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'B Cohort', 'description': 'Grade 1/2 treatment-related adverse events (AEs) occurred in 3 patients.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'C Cohort', 'description': 'Grade 1/2 treatment-related adverse events (AEs) occurred in 2 patients.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Lymphopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Premature beats', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Increased AST', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Increased ALT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Fever', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Infusion-related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and Tolerability of Dose of PD-1 Knockout T Cells Using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-A Cohort', 'description': 'All adverse events are grade 1-2.'}, {'id': 'OG001', 'title': 'A Cohort', 'description': 'All adverse events are grade 1-2.'}, {'id': 'OG002', 'title': 'B Cohort', 'description': 'All adverse events are grade 1-2.'}, {'id': 'OG003', 'title': 'C Cohort', 'description': 'All adverse events are grade 1-2.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Dose Escalation - Approximately 6 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Overall Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-A Cohort', 'description': 'In Pre-A Cohort, all patient were assessed per RECIST v1.1'}, {'id': 'OG001', 'title': 'A Cohort', 'description': 'In A Cohort, 3 patients were assessed per RECIST v1.1. One patient was unavailable for tumor response assessment due to early withdrawal.'}, {'id': 'OG002', 'title': 'B Cohort', 'description': 'In B Cohort, all patients were assessed per RECIST v1.1.'}, {'id': 'OG003', 'title': 'C Cohort', 'description': 'In C Cohort, all patients were assessed per RECIST v1.1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '3 months', 'description': 'Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Disease Control at 8 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-A Cohort', 'description': 'In Pre-A Cohort, all two patients were assessed per RECIST v1.1.'}, {'id': 'OG001', 'title': 'A Cohort', 'description': '3 patients were assessed per RECIST v1.1. One patient was unavailable for tumor response assessment due to early withdrawal.'}, {'id': 'OG002', 'title': 'B Cohort', 'description': 'In B Cohort, all patients were assessed per RECIST v1.1.'}, {'id': 'OG003', 'title': 'C Cohort', 'description': 'All patients were assessed per RECIST v1.1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '8 weeks', 'description': 'Response will be evaluated according to RECIST v1.1 for target lesions at Week 8：Complete Response (CR), Disappearance of all extranodal target lesions; Partial Response (PR) ≥ 30% decrease in the sum of diameters of target lesions; Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Disease control = CR +PR+SD', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Progression Free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-A Cohort', 'description': 'In Pre-A Cohort, all two patients were assessed per RECIST v1.1.'}, {'id': 'OG001', 'title': 'A Cohort', 'description': 'All patients were assessed per RECIST v1.1.'}, {'id': 'OG002', 'title': 'B Cohort', 'description': 'In B Cohort, all patients were assessed per RECIST v1.1.'}, {'id': 'OG003', 'title': 'C Cohort', 'description': 'All patients were assessed per RECIST v1.1.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'groupId': 'OG000', 'lowerLimit': '5.6', 'upperLimit': '17.7'}, {'value': '8.0', 'groupId': 'OG001', 'lowerLimit': '7.3', 'upperLimit': '8.4'}, {'value': '8.1', 'groupId': 'OG002', 'lowerLimit': '7.4', 'upperLimit': '75.7'}, {'value': '6.1', 'groupId': 'OG003', 'lowerLimit': '5.0', 'upperLimit': '8.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'The time from the date of first edited T cell infusion to the date of disease progression or death due to any reason.', 'description': 'Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-A Cohort', 'description': 'In Pre-A Cohort, two patients were followed up.'}, {'id': 'OG001', 'title': 'A Cohort', 'description': 'All patients were followed up.'}, {'id': 'OG002', 'title': 'B Cohort', 'description': 'In B Cohort, all patients were followed up.'}, {'id': 'OG003', 'title': 'C Cohort', 'description': 'All patients were followed up.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.5', 'groupId': 'OG000', 'lowerLimit': '42.6', 'upperLimit': '52.4'}, {'value': '51.4', 'groupId': 'OG001', 'lowerLimit': '13.4', 'upperLimit': '116'}, {'value': '32.6', 'groupId': 'OG002', 'lowerLimit': '24.4', 'upperLimit': '97.7'}, {'value': '51.6', 'groupId': 'OG003', 'lowerLimit': '21', 'upperLimit': '96.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'The duration from date of first edited T cell infusion to the date of death due to any reason', 'description': 'OS is defined as the time interval from date of first edited T cell infusion to the date of death due to any reason', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Genes Mutations in Peripheral Blood Circulating Tumor DNA (ctDNA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-A Cohort', 'description': 'All patients were tested for gene mutation status in ctDNA at baseline'}, {'id': 'OG001', 'title': 'A Cohort', 'description': 'All patients were tested for gene mutation status in ctDNA at baseline'}, {'id': 'OG002', 'title': 'B Cohort', 'description': 'All patients were tested for gene mutation status in ctDNA at baseline'}, {'id': 'OG003', 'title': 'C Cohort', 'description': 'All patients were tested for gene mutation status in ctDNA at baseline'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline', 'description': 'Driver genes mutaion stauts of Participants in ctDNA from peripheral blood were assessed by next generation sequencing (NGS), to explore the positive rate of sepicif driver genes (e.g. EGFR, ALK, ROS1, etc.) and the relationship between gene mutation status and clinical response', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only three patients were detected with EGFR mutations. Correlation between driver gene mutations with clinical outcome were not analyzed due to limited data. EGFR positive rate was showed in outcome measure data table.'}, {'type': 'SECONDARY', 'title': 'Interleukin-6 Change in the Peripheral Blood.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-A Cohort', 'description': 'In Pre-A Cohort, one patient provided blood smaple at baseline, month 1 and month 3, the other patient provided blood sample only at baseline and month 1.'}, {'id': 'OG001', 'title': 'A Cohort', 'description': "Three patients were collected blood at baseline and month 1. The other patient's sample was not collected owing to early withdrawal from the trial. All patients had relapsed disease before month 3 and were not able to samples at month 3."}, {'id': 'OG002', 'title': 'B Cohort', 'description': "In B Cohort, One patient's blood was collected at baseline, month 1 and month 3. The other two patients' sample were collected only at baseline and month 1 owing to PD before month 3."}, {'id': 'OG003', 'title': 'C Cohort', 'description': "In C Cohort, One patient's blood was collected blood at baseline, month 1 and month 3. The other two patients' blood were only collected blood at baseline and month 1, owing to PD before month 3."}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.68', 'groupId': 'OG000', 'lowerLimit': '8.98', 'upperLimit': '12.38'}, {'value': '3.27', 'groupId': 'OG001', 'lowerLimit': '2.62', 'upperLimit': '61.87'}, {'value': '51.97', 'groupId': 'OG002', 'lowerLimit': '8.09', 'upperLimit': '67.09'}, {'value': '10.59', 'groupId': 'OG003', 'lowerLimit': '10.28', 'upperLimit': '11.45'}]}]}, {'title': '1 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12.9', 'groupId': 'OG000', 'lowerLimit': '1.5', 'upperLimit': '24.3'}, {'value': '4.37', 'groupId': 'OG001', 'lowerLimit': '2.39', 'upperLimit': '90.17'}, {'value': '23.92', 'groupId': 'OG002', 'lowerLimit': '5.58', 'upperLimit': '137.1'}, {'value': '14.77', 'groupId': 'OG003', 'lowerLimit': '8.48', 'upperLimit': '26.17'}]}]}, {'title': '3 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '18.45', 'groupId': 'OG000', 'lowerLimit': '18.45', 'upperLimit': '18.45'}, {'value': '4.03', 'groupId': 'OG002', 'lowerLimit': '4.03', 'upperLimit': '4.03'}, {'value': '12.49', 'groupId': 'OG003', 'lowerLimit': '12.49', 'upperLimit': '12.49'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 1 month and 3 month', 'description': 'Peripheral Interleukin-6 level at different timepoint (Baseline, 1 month and 3 month) was measured using rate nephelometry', 'unitOfMeasure': 'pg/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One patients did not provide blood sample due to early withdrawal; blood samples of 8 patients were only collected at baseline and month 1 due to PD before month 3'}, {'type': 'SECONDARY', 'title': 'Interleukin-10 Change in the Peripheral Blood.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-A Cohort', 'description': "In Pre-A Cohort, one patient's blood was collected blood at baseline, month 1 and month 3, the other patient's blood was collected at baseline and month 1."}, {'id': 'OG001', 'title': 'A Cohort', 'description': "Three patients' samples were collected at baseline and month 1. The other patient's sample was not collected owing to early withdrawal from the trial. All patients had relapsed disease before month 3 and did not provide samples at month 3"}, {'id': 'OG002', 'title': 'B Cohort', 'description': "In B Cohort, One patient's sample was collected at baseline, month 1 and month 3. The other two patients' samples were collected only at baseline and month 1, owing to PD before month 3."}, {'id': 'OG003', 'title': 'C Cohort', 'description': "In C Cohort, one patient's sample was collected at baseline, month 1 and month 3. The other two patients' samples were collected only at baseline and month 1, owing to PD before month 3."}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '5.00', 'upperLimit': '5.00'}, {'value': '5.00', 'groupId': 'OG001', 'lowerLimit': '5.00', 'upperLimit': '5.00'}, {'value': '5.00', 'groupId': 'OG002', 'lowerLimit': '5.00', 'upperLimit': '5.00'}, {'value': '5.00', 'groupId': 'OG003', 'lowerLimit': '5.00', 'upperLimit': '5.00'}]}]}, {'title': '1 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '5.00', 'upperLimit': '5.00'}, {'value': '5.00', 'groupId': 'OG001', 'lowerLimit': '5.00', 'upperLimit': '5.00'}, {'value': '19.05', 'groupId': 'OG002', 'lowerLimit': '7.3', 'upperLimit': '30.8'}, {'value': '5.00', 'groupId': 'OG003', 'lowerLimit': '5.00', 'upperLimit': '5.00'}]}]}, {'title': '3 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '5.00', 'upperLimit': '5.00'}, {'value': '27.10', 'groupId': 'OG002', 'lowerLimit': '27.10', 'upperLimit': '27.10'}, {'value': '5.00', 'groupId': 'OG003', 'lowerLimit': '5.00', 'upperLimit': '5.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 1 month and 3 month', 'description': 'Peripheral Interleukin-10 level at different timepoint (Baseline, 1 month and 3 month) was measured using chemiluminescence.', 'unitOfMeasure': 'pg/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One patients did not provide blood sample due to early withdrawal; blood samples of 8 patients were only collected at baseline and month 1 due to PD before month 3'}, {'type': 'SECONDARY', 'title': 'Tumor Necrosis Factor-a Change in the Peripheral Blood.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-A Cohort', 'description': "In Pre-A Cohort, one patient's blood was collected at baseline, month 1 and month 3, the other patient's blood was collected only at baseline and month 1."}, {'id': 'OG001', 'title': 'A Cohort', 'description': "Three patients provided blood samples at baseline and month 1. The other patient's sample was not collected owing to early withdrawal from the trial. All patients had relapsed disease before month 3 and were not able to provide samples at month 3"}, {'id': 'OG002', 'title': 'B Cohort', 'description': "In B Cohort, one patient's sample was collected at baseline, month 1 and month 3. The other two patients' sample were collected only at baseline, month 1 owing to PD before month 3."}, {'id': 'OG003', 'title': 'C Cohort', 'description': "In C Cohort, one patient's sample was collected at baseline, month 1 and month 3. The other two patients' sample were collected only at baseline, month 1 owing to PD before month 3."}], 'classes': [{'title': 'baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '13.84', 'groupId': 'OG000', 'lowerLimit': '7.97', 'upperLimit': '19.7'}, {'value': '6.07', 'groupId': 'OG001', 'lowerLimit': '5.61', 'upperLimit': '8.53'}, {'value': '8.89', 'groupId': 'OG002', 'lowerLimit': '5.30', 'upperLimit': '8.92'}, {'value': '5.06', 'groupId': 'OG003', 'lowerLimit': '4.01', 'upperLimit': '6.28'}]}]}, {'title': '1 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10.68', 'groupId': 'OG000', 'lowerLimit': '7.65', 'upperLimit': '13.7'}, {'value': '7.84', 'groupId': 'OG001', 'lowerLimit': '5.74', 'upperLimit': '7.92'}, {'value': '10.40', 'groupId': 'OG002', 'lowerLimit': '4.2', 'upperLimit': '11.9'}, {'value': '16.4', 'groupId': 'OG003', 'lowerLimit': '6.31', 'upperLimit': '27.70'}]}]}, {'title': '3 month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6.97', 'groupId': 'OG000', 'lowerLimit': '6.97', 'upperLimit': '6.97'}, {'value': '10.90', 'groupId': 'OG002', 'lowerLimit': '10.90', 'upperLimit': '10.90'}, {'value': '11.70', 'groupId': 'OG003', 'lowerLimit': '11.70', 'upperLimit': '11.70'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, 1 month and 3 month', 'description': 'Peripheral Tumor Necrosis Factor-a level at different timepoint (Baseline, 1 month and 3 month) was measured using chemiluminescence.', 'unitOfMeasure': 'pg/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'One patients did not provide blood sample due to early withdrawal; blood samples of 8 patients were only collected at baseline and month 1 due to PD before month 3'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pre-A-One Cycle', 'description': 'Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.\n\nA total of 2 x 10\\^7/kg PD-1 Knockout T cells will be infused in one cycle which is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of one cycle of treatment.\n\nCyclophosphamide: To deplete Tregs before collecting peripheral blood\n\nPD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment'}, {'id': 'FG001', 'title': 'A - Two Cycles', 'description': 'Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.\n\nA total of 1 x 10\\^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.\n\nCyclophosphamide: To deplete Tregs before collecting peripheral blood\n\nPD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment'}, {'id': 'FG002', 'title': 'B- Two Cycles', 'description': 'Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.\n\nA total of 2 x 10\\^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.\n\nCyclophosphamide: To deplete Tregs before collecting peripheral blood\n\nPD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment'}, {'id': 'FG003', 'title': 'C- Two Cycles', 'description': 'Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.\n\nA total of 4 x 10\\^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.\n\nCyclophosphamide: To deplete Tregs before collecting peripheral blood\n\nPD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Pre-A-One Cycle', 'description': 'Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.\n\nA total of 2 x 10\\^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of one cycle of treatment.\n\nCyclophosphamide: To deplete Tregs before collecting peripheral blood\n\nPD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment'}, {'id': 'BG001', 'title': 'A - Two Cycles', 'description': 'Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.\n\nA total of 1 x 10\\^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.\n\nCyclophosphamide: To deplete Tregs before collecting peripheral blood\n\nPD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment'}, {'id': 'BG002', 'title': 'B- Two Cycles', 'description': 'Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.\n\nA total of 2 x 10\\^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.\n\nCyclophosphamide: To deplete Tregs before collecting peripheral blood\n\nPD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment'}, {'id': 'BG003', 'title': 'C- Two Cycles', 'description': 'Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.\n\nA total of 4 x 10\\^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.\n\nCyclophosphamide: To deplete Tregs before collecting peripheral blood\n\nPD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.5', 'groupId': 'BG000', 'lowerLimit': '48', 'upperLimit': '63'}, {'value': '56', 'groupId': 'BG001', 'lowerLimit': '48', 'upperLimit': '66'}, {'value': '55', 'groupId': 'BG002', 'lowerLimit': '31', 'upperLimit': '68'}, {'value': '53', 'groupId': 'BG003', 'lowerLimit': '47', 'upperLimit': '61'}, {'value': '54.5', 'groupId': 'BG004', 'lowerLimit': '31', 'upperLimit': '68'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.5', 'groupId': 'BG000', 'lowerLimit': '48', 'upperLimit': '63'}, {'value': '56', 'groupId': 'BG001', 'lowerLimit': '48', 'upperLimit': '66'}, {'value': '55', 'groupId': 'BG002', 'lowerLimit': '31', 'upperLimit': '68'}, {'value': '53', 'groupId': 'BG003', 'lowerLimit': '47', 'upperLimit': '61'}, {'value': '54.5', 'groupId': 'BG004', 'lowerLimit': '31', 'upperLimit': '68'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'China', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-12-04', 'size': 2012479, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-04-25T18:43', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-19', 'studyFirstSubmitDate': '2016-05-30', 'resultsFirstSubmitDate': '2020-04-25', 'studyFirstSubmitQcDate': '2016-06-07', 'lastUpdatePostDateStruct': {'date': '2021-01-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-11-24', 'studyFirstPostDateStruct': {'date': '2016-06-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and Tolerability of Dose of PD-1 Knockout T Cells Using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in Patients', 'timeFrame': 'Dose Escalation - Approximately 6 months'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Overall Response', 'timeFrame': '3 months', 'description': 'Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."'}, {'measure': 'Number of Patients With Disease Control at 8 Weeks', 'timeFrame': '8 weeks', 'description': 'Response will be evaluated according to RECIST v1.1 for target lesions at Week 8：Complete Response (CR), Disappearance of all extranodal target lesions; Partial Response (PR) ≥ 30% decrease in the sum of diameters of target lesions; Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Disease control = CR +PR+SD'}, {'measure': 'Progression Free Survival (PFS)', 'timeFrame': 'The time from the date of first edited T cell infusion to the date of disease progression or death due to any reason.', 'description': 'Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'The duration from date of first edited T cell infusion to the date of death due to any reason', 'description': 'OS is defined as the time interval from date of first edited T cell infusion to the date of death due to any reason'}, {'measure': 'Number of Participants With Genes Mutations in Peripheral Blood Circulating Tumor DNA (ctDNA)', 'timeFrame': 'Baseline', 'description': 'Driver genes mutaion stauts of Participants in ctDNA from peripheral blood were assessed by next generation sequencing (NGS), to explore the positive rate of sepicif driver genes (e.g. EGFR, ALK, ROS1, etc.) and the relationship between gene mutation status and clinical response'}, {'measure': 'Interleukin-6 Change in the Peripheral Blood.', 'timeFrame': 'Baseline, 1 month and 3 month', 'description': 'Peripheral Interleukin-6 level at different timepoint (Baseline, 1 month and 3 month) was measured using rate nephelometry'}, {'measure': 'Interleukin-10 Change in the Peripheral Blood.', 'timeFrame': 'Baseline, 1 month and 3 month', 'description': 'Peripheral Interleukin-10 level at different timepoint (Baseline, 1 month and 3 month) was measured using chemiluminescence.'}, {'measure': 'Tumor Necrosis Factor-a Change in the Peripheral Blood.', 'timeFrame': 'Baseline, 1 month and 3 month', 'description': 'Peripheral Tumor Necrosis Factor-a level at different timepoint (Baseline, 1 month and 3 month) was measured using chemiluminescence.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['lung cancer', 'immune checkpoint', 'PD-1', 'CRISPR', 'autologous cell infusion'], 'conditions': ['Metastatic Non-small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '25891174', 'type': 'BACKGROUND', 'citation': 'Garon EB, Rizvi NA, Hui R, Leighl N, Balmanoukian AS, Eder JP, Patnaik A, Aggarwal C, Gubens M, Horn L, Carcereny E, Ahn MJ, Felip E, Lee JS, Hellmann MD, Hamid O, Goldman JW, Soria JC, Dolled-Filhart M, Rutledge RZ, Zhang J, Lunceford JK, Rangwala R, Lubiniecki GM, Roach C, Emancipator K, Gandhi L; KEYNOTE-001 Investigators. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med. 2015 May 21;372(21):2018-28. doi: 10.1056/NEJMoa1501824. Epub 2015 Apr 19.'}, {'pmid': '26028407', 'type': 'BACKGROUND', 'citation': 'Brahmer J, Reckamp KL, Baas P, Crino L, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Aren Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbison CT, Lestini B, Spigel DR. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. doi: 10.1056/NEJMoa1504627. Epub 2015 May 31.'}, {'pmid': '26412456', 'type': 'BACKGROUND', 'citation': 'Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhaufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crino L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27.'}, {'pmid': '25838374', 'type': 'BACKGROUND', 'citation': 'Rosenberg SA, Restifo NP. Adoptive cell transfer as personalized immunotherapy for human cancer. Science. 2015 Apr 3;348(6230):62-8. doi: 10.1126/science.aaa4967.'}, {'pmid': '25860605', 'type': 'BACKGROUND', 'citation': 'Sharma P, Allison JP. Immune checkpoint targeting in cancer therapy: toward combination strategies with curative potential. Cell. 2015 Apr 9;161(2):205-14. doi: 10.1016/j.cell.2015.03.030.'}, {'pmid': '24486104', 'type': 'BACKGROUND', 'citation': 'Niu Y, Shen B, Cui Y, Chen Y, Wang J, Wang L, Kang Y, Zhao X, Si W, Li W, Xiang AP, Zhou J, Guo X, Bi Y, Si C, Hu B, Dong G, Wang H, Zhou Z, Li T, Tan T, Pu X, Wang F, Ji S, Zhou Q, Huang X, Ji W, Sha J. Generation of gene-modified cynomolgus monkey via Cas9/RNA-mediated gene targeting in one-cell embryos. Cell. 2014 Feb 13;156(4):836-43. doi: 10.1016/j.cell.2014.01.027. Epub 2014 Jan 30.'}, {'pmid': '32341578', 'type': 'DERIVED', 'citation': 'Lu Y, Xue J, Deng T, Zhou X, Yu K, Deng L, Huang M, Yi X, Liang M, Wang Y, Shen H, Tong R, Wang W, Li L, Song J, Li J, Su X, Ding Z, Gong Y, Zhu J, Wang Y, Zou B, Zhang Y, Li Y, Zhou L, Liu Y, Yu M, Wang Y, Zhang X, Yin L, Xia X, Zeng Y, Zhou Q, Ying B, Chen C, Wei Y, Li W, Mok T. Safety and feasibility of CRISPR-edited T cells in patients with refractory non-small-cell lung cancer. Nat Med. 2020 May;26(5):732-740. doi: 10.1038/s41591-020-0840-5. Epub 2020 Apr 27.'}, {'pmid': '27641687', 'type': 'DERIVED', 'citation': 'Yi L, Li J. CRISPR-Cas9 therapeutics in cancer: promising strategies and present challenges. Biochim Biophys Acta. 2016 Dec;1866(2):197-207. doi: 10.1016/j.bbcan.2016.09.002. Epub 2016 Sep 15.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety of PD-1 knockout engineered T cells in treating metastatic non-small cell lung cancer. Blood samples will also be collected for research purposes.', 'detailedDescription': 'This is a dose-escalation study of ex-vivo knocked-out, expanded, and selected PD-1 knockout-T cells from autologous origin. Patients are assigned to 1 of 3 treatment groups to determine the maximal tolerant dose. After the lower number of cycles are considered tolerant, an arm of the next higher number of cycles will be open to next patients. Biomarkers and immunological markers are collected and analyzed as well.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologically verified stage IV non-small cell lung cancer with measurable lesions (On CT: longest diameter of tumoral lesion \\>=10 mm, shorted diameter of lymph node \\>=15 mm; measurable lesions should not have been irradiated)\n* Progressed after all standard treatment\n* Performance score: 0-1\n* Expected life span: \\>= 6 months\n* Toxicities from prior treatment has resolved. Washout period is 4 weeks for chemotherapy, and 2 weeks for targeted therapy\n* Major organs function normally\n* Women at pregnant ages should be under contraception\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* Pathology is mixed type\n* Emergent treatment of tumor emergency is needed\n* Poor vasculature\n* Coagulopathy, or ongoing thrombolytics and/or anticoagulation\n* Blood-borne infectious disease, e.g. hepatitis B\n* History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician\n* With other immune diseases, or chronic use of immunosuppressants or steroids\n* Compliance cannot be expected\n* Other conditions requiring exclusion deemed by physician'}, 'identificationModule': {'nctId': 'NCT02793856', 'briefTitle': 'PD-1 Knockout Engineered T Cells for Metastatic Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sichuan University'}, 'officialTitle': 'A Phase I Clinical Trial of PD-1 Knockout Engineered T Cells Treating Patients With Advanced Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'MHC-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A - Two cycles', 'description': 'Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.\n\nA total of 1 x 10\\^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.', 'interventionNames': ['Drug: Cyclophosphamide', 'Other: PD-1 Knockout T Cells']}, {'type': 'EXPERIMENTAL', 'label': 'B- Two cycles', 'description': 'Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.\n\nA total of 2 x 10\\^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.', 'interventionNames': ['Drug: Cyclophosphamide', 'Other: PD-1 Knockout T Cells']}, {'type': 'EXPERIMENTAL', 'label': 'C- Two cycles', 'description': 'Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.\n\nA total of 4 x 10\\^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.', 'interventionNames': ['Drug: Cyclophosphamide', 'Other: PD-1 Knockout T Cells']}], 'interventions': [{'name': 'Cyclophosphamide', 'type': 'DRUG', 'otherNames': ['Cytoxan'], 'description': 'To deplete Tregs before collecting peripheral blood', 'armGroupLabels': ['A - Two cycles', 'B- Two cycles', 'C- Two cycles']}, {'name': 'PD-1 Knockout T Cells', 'type': 'OTHER', 'description': 'Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment', 'armGroupLabels': ['A - Two cycles', 'B- Two cycles', 'C- Two cycles']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}], 'overallOfficials': [{'name': 'You Lu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sichuan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sichuan University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chengdu MedGenCell, Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair of Department of Thoracic Cancer', 'investigatorFullName': 'You Lu', 'investigatorAffiliation': 'Sichuan University'}}}}