Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-01-07 @ 6:21 AM
Study NCT ID:
NCT04094766
Status:
WITHDRAWN
Last Update Posted:
2020-11-05
First Post:
2019-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy in R/R Acute B Lymphoblastic Leukemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002051', 'term': 'Burkitt Lymphoma'}], 'ancestors': [{'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'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{'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Production plan adjustment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-03', 'studyFirstSubmitDate': '2019-09-17', 'studyFirstSubmitQcDate': '2019-09-17', 'lastUpdatePostDateStruct': {'date': '2020-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Copy numbers of CAR-T cells in patients', 'timeFrame': 'Day 1-5 years after injection'}], 'primaryOutcomes': [{'measure': 'Occurrence of treatment related adverse events', 'timeFrame': 'Day 1-100 days after injection', 'description': 'Assessed by CTCAE v4.0'}], 'secondaryOutcomes': [{'measure': 'Objective response rate', 'timeFrame': 'Day 1-5 years after injection', 'description': 'Objective response include complete remission and partial remission'}, {'measure': 'Overall survival', 'timeFrame': 'Day 1-5 years after injection'}, {'measure': 'Progression free survival', 'timeFrame': 'Day 1-5 years after injection'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Chimeric Antigen Receptor T cells', 'CD19 and CD22'], 'conditions': ['Refractory B Acute Lymphoblastic Leukemia', 'Relapse B Acute Lymphoblastic Leukemia']}, 'descriptionModule': {'briefSummary': 'This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of dual specificity CD19 and CD22 CAR-T cells in patients with relapsed and refractory acute B lymphoblastic leukemia.', 'detailedDescription': 'CD19-directed CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory acute B lymphoblastic leukemia. CD19 and CD22 are proteins usually expressed on the surface of the B leukemia cells. The dual specificity CAR enables the T-cells to recognize and kill the tumor cell through recognition of CD19 and CD22.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '60 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent could be acquired;\n2. Diagnosed with relapse/refractory acute lymphoblastic leukemia;\n3. Relapse was defined as recurrence of blast cell(more than 5%) in peripheral blood or in bone marrow or extramedullary involvement;\n4. Refractory was defined as failed to achieve complete remission after two courses of induction therapy;\n5. CD19/CD22 postive leukemia cell was confirmed by flow cytometry or immunohistochemistry within 90 days since enrollment in this trial;\n6. Karnofsky score ≥70;\n7. Results of pregnant test should be negative, and agree to conception control during treatment and 6 months after CAR-T infusion.\n8. Adequate organ function: EF≥50%; normal ECG; CCR ≥ 50ml/min or Cr \\< 2.0mg/dL or \\< 2 times upper limitation of normal; ALT and AST\\<5 times upper limitation of normal; Serum bilirubin ≤ 3.0mg/dL; DLCO or FEV1 \\> 45% of predict value;\n9. At least 2 weeks intervals since the last chemotherapy;\n10. At least 2 weeks intervals since the last anti-GVHD therapy if patients have ever ;\n\nExclusion Criteria:\n\n1. Patients diagnosed with acute promyelocytic leukemia:t(15;17)(q22;q12);\n2. Women in pregnancy and lactation;\n3. Uncontrolled infection, Active HBV or HCV infection, HIV positive or any other deadly bacterial/virual diseases;\n4. Long term use of systemic corticosteroids(5mg per day for 2 weeks);\n5. Any other uncontrolled life-threaten diseases;\n6. Patients with history of anaphylaxis to any drugs;\n7. With central nervous system (CNS) involvement;\n8. Patients with GVHD after allo-HSCT who needed immunosuppressive agents ;\n9. Patients with acute autoimmune diseases such as psoriasis or rheumatoid arthritis;\n10. Other conditions that principle investigator considered may increase the risk of the patients or interference the results.'}, 'identificationModule': {'nctId': 'NCT04094766', 'briefTitle': 'Safety and Efficacy of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy in R/R Acute B Lymphoblastic Leukemia', 'organization': {'class': 'OTHER', 'fullName': "Second Affiliated Hospital of Xi'an Jiaotong University"}, 'officialTitle': 'A Phase I Clinical Study of Dual Specificity CD19 and CD22 Chimeric Antigen Receptor T Cell Therapy in Relapsed or Refractory Acute B Lymphoblastic Leukemia', 'orgStudyIdInfo': {'id': 'XJTU-BLLCAR-L10D'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BLLCAR-L10D treatment group', 'description': 'In BLLCAR-L10D treatment group, patients will be treated with dual specificity CD19 and CD22 CAR-T cells with a escalation approach, 3 CAR-T dosage will be tested in this study: 0.5×10\\^6, 1.5×10\\^6, 2.0×10\\^6 CAR-T cells/kg.', 'interventionNames': ['Drug: Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy']}], 'interventions': [{'name': 'Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy', 'type': 'DRUG', 'description': 'Patients will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CAR-T cells. After a pre-treatment lymphodepletion therapy, patients will receive the Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy by intravenous injection.', 'armGroupLabels': ['BLLCAR-L10D treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710000', 'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'facility': "Second Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Aili He, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Second Affiliated Hospital of Xi'an Jiaotong University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Second Affiliated Hospital of Xi'an Jiaotong University", 'class': 'OTHER'}, 'collaborators': [{'name': 'Nanjing Legend Biotech Co.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}