Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-01-18 @ 3:07 PM
Study NCT ID:
NCT04260932
Status:
COMPLETED
Last Update Posted:
2022-03-08
First Post:
2020-02-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD19/CD20 Dual-CAR-T in B-cell Lymphoma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-06', 'studyFirstSubmitDate': '2020-02-06', 'studyFirstSubmitQcDate': '2020-02-06', 'lastUpdatePostDateStruct': {'date': '2022-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants with adverse events.', 'timeFrame': '6 months'}, {'measure': 'Objective remission rate(ORR)', 'timeFrame': '6 months', 'description': 'The percentage of participants who achieved complete remission (CR) and partial remission over all participants.'}], 'secondaryOutcomes': [{'measure': 'Relapse-Free Survival(RFS )', 'timeFrame': '6 months'}, {'measure': 'Overall-Survival(OS)', 'timeFrame': '6 months'}, {'measure': 'Persistence of CAR-T cells in vivo', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['B-cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of CD19/CD20 Dual-CAR-T cells in patients with refractory and relapsed B-cell lymphoma.', 'detailedDescription': 'This Phase I study is designed as a pilot trial evaluating the safety and efficacy of CD19/CD20 Dual-CAR-T cell therapy in subjects with refractory and relapsed B cell lymphoma. Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19/CD20 Dual-CAR-T cells. Safety and efficacy of CD19/CD20 Dual-CAR-T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19/CD20 Dual-CAR-T cells therapy in patients with refractory and relapsed B-cell lymphoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Relapsed and refractory B-cell lymphoma with:\n\n Relapsed or refractory disease after ≥2 lines of chemotherapy including rituximab and anthracycline and either having failed after autologous or allogeneic hematopoietic stem cell transplantation (ASCT);\n2. Patients must have evaluable evidence of disease, including minimal residual disease (MRD);\n3. Double positive expression of CD19 / CD20 in B cells;\n4. Ages 1 to 80 years, including boundary values;\n5. ECOG score 0-3 points;\n6. Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside;\n7. Patients who voluntarily sign informed consent and are willing to comply with treatment plans.\n\nExclusion Criteria:\n\n1. patients with organ failure:\n\n * Heart: NYHA heart function grade IV;\n * Liver: Grade C that achieves Child-Turcotte liver function grading;\n * Kidney: kidney failure and uremia;\n * Lung: symptoms of respiratory failure;\n * Brain: a person with a disability;\n2. Active infections that are difficult to control;\n3. Human immunodeficiency virus (HIV) positive;\n4. Liver and kidney function: total bilirubin \\> 5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\> 5 × ULN, serum creatinine clearance rate 60mL / min;\n5. GVHD ≥ 2 or anti-GVHD treatment;\n6. intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation;\n7. pregnant or lactating women;\n8. The patient does not agree to use effective contraception during the treatment period and for the next 3 months;\n9. Patients who participate in other clinical studies at the same time;\n10. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study."}, 'identificationModule': {'nctId': 'NCT04260932', 'briefTitle': 'CD19/CD20 Dual-CAR-T in B-cell Lymphoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hebei Yanda Ludaopei Hospital'}, 'officialTitle': 'CD19/CD20 Dual-CAR-T for Patients With B-cell Lymphoma', 'orgStudyIdInfo': {'id': 'HXYT-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CD19/CD20 Dual-CAR-T cells', 'description': 'CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for at least 2 days before infusion.', 'interventionNames': ['Biological: CD19/CD20 Dual-CAR-T cells']}], 'interventions': [{'name': 'CD19/CD20 Dual-CAR-T cells', 'type': 'BIOLOGICAL', 'description': 'CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest at least for 2 days before infusion. CD19/CD20 Dual-CAR-T cells will be intravenously infused with a escalated dose of 1-6×106 cells/kg.', 'armGroupLabels': ['CD19/CD20 Dual-CAR-T cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '065200', 'city': 'Sanhe', 'state': 'Hebei', 'country': 'China', 'facility': 'Hebei Yanda Ludaopei Hospital', 'geoPoint': {'lat': 39.98049, 'lon': 117.06887}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebei Yanda Ludaopei Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'China Immunotech (Beijing) Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}