Clinical trial
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
Name
GC011-411
Description
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.
Trial arms
Trial start
2021-09-29
Estimated PCD
2024-08-31
Trial end
2024-11-30
Status
Recruiting
Phase
Early phase I
Treatment
Anti-CD19 Universal CAR-T Cells injection
Anti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion.
Arms:
Anti-CD19 Universal CAR-T Cells injection
Size
15
Primary endpoint
Dose Limiting Toxicities
Up to 4 weeks after CAR-T infusion
Eligibility criteria
Key Inclusion Criteria:
1. Eastern Cooperative Oncology Group Performance Status of 0 or 1；
2. Expected survival time ≥12 weeks;
3. Adequate hematological, renal and liver function;
4. Subjects understand and voluntarily sign the informed consent form.
Key Exclusion Criteria:
1. Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA ;
2. Cyclophosphamide or fludarabine is contraindicated for subjects ;
3. Active central nervous system (CNS) involvement by malignancy；
4. Active infection.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 15, 'type': 'ESTIMATED'}}
Updated at
2023-05-10
1 organization
1 product
2 indications
Indication
B-cell Acute Lymphoblastic LeukemiaIndication
B-cell Non-Hodgkin Lymphoma