Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-29 @ 10:41 PM
Study NCT ID:
NCT05105867
Status:
UNKNOWN
Last Update Posted:
2023-05-10
First Post:
2021-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD19 Targeted Universal Chimeric Antigen Receptor T Cells Injection for CD19+ Refractory/Relapsed B-cell Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D002051', 'term': 'Burkitt Lymphoma'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': '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': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-08', 'studyFirstSubmitDate': '2021-10-25', 'studyFirstSubmitQcDate': '2021-10-25', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Limiting Toxicities', 'timeFrame': 'Up to 4 weeks after CAR-T infusion', 'description': 'Incidence of dose-limiting toxicities as protocol-defined'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'At 4,12,24 weeks after CAR-T infusion', 'description': 'Objective response rate after CAR-T infusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia', 'Relapsed or Refractory B-cell Non-hodgkin Lymphoma']}, 'descriptionModule': {'briefSummary': 'It is a single-arm, open-label clinical study to assess the safety and efficacy of the Anti-CD19 Universal CAR-T Cells injection for patients with CD19+ refractory/relapsed B cell acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma.', 'detailedDescription': 'The study consists of the following periods: screening, lymphodepletion, CAR-T cell infusion, safety follow up, and long term follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group Performance Status of 0 or 1；\n2. Expected survival time ≥12 weeks;\n3. Adequate hematological, renal and liver function;\n4. Subjects understand and voluntarily sign the informed consent form.\n\nKey Exclusion Criteria:\n\n1. Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA ;\n2. Cyclophosphamide or fludarabine is contraindicated for subjects ;\n3. Active central nervous system (CNS) involvement by malignancy；\n4. Active infection.'}, 'identificationModule': {'nctId': 'NCT05105867', 'briefTitle': 'CD19 Targeted Universal Chimeric Antigen Receptor T Cells Injection for CD19+ Refractory/Relapsed B-cell Malignancies', 'organization': {'class': 'OTHER', 'fullName': "920th Hospital of Joint Logistics Support Force of People's Liberation Army of China"}, 'officialTitle': 'A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of Anti-CD19 Universal CAR-T Cells in the Treatment of CD19+ Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia and Relapsed/Refractory B-cell Non-Hodgkin Lymphoma', 'orgStudyIdInfo': {'id': 'GC011-411'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anti-CD19 Universal CAR-T Cells injection', 'description': 'Anti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion .', 'interventionNames': ['Biological: Anti-CD19 Universal CAR-T Cells injection']}], 'interventions': [{'name': 'Anti-CD19 Universal CAR-T Cells injection', 'type': 'BIOLOGICAL', 'description': 'Anti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion.', 'armGroupLabels': ['Anti-CD19 Universal CAR-T Cells injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '650000', 'city': 'Kunming', 'state': 'Yunnan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Sanbin Wang, Professor', 'role': 'CONTACT', 'email': 'Sanbin1011@163.com', 'phone': '13187424131', 'phoneExt': '+86'}], 'facility': "920th Hospital of Joint Logistics Support Force of People's Liberation Army of China", 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}], 'centralContacts': [{'name': 'Sanbin Wang, Professor', 'role': 'CONTACT', 'email': 'Sanbin1011@163.com', 'phone': '13187424131', 'phoneExt': '+86'}], 'overallOfficials': [{'name': 'Sanbin Wang, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "920th Hospital of Joint Logistics Support Force of People's Liberation Army of China"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "920th Hospital of Joint Logistics Support Force of People's Liberation Army of China", 'class': 'OTHER'}, 'collaborators': [{'name': 'Gracell Biotechnologies (Shanghai) Co., Ltd.', 'class': 'INDUSTRY'}, {'name': 'Kunming Hope of Health Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}