Donor-Derived CD5 CAR T Cells in Subjects with Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia
Summary
This is a FIH, single center, open label, non-randomized, single-arm, Phase I clinical trial to evaluate the safety and tolerability of CD5 CAR T cells in subjects with relapsed or refractory T-cell acute lymphoblastic leukemia. At least 18 subjects will be enrolled. After the collection of PBMC and about 5 days before infusion, lymphodepletion (fludarabine at 30 mg/m\^2/day and cyclophosphamide at 250 mg/m\^2/day; for prior-SCT donor-derived CAR T-cell infusion) or intensified lymphodepletion (fludarabine at 30 mg/m\^2/day and cyclophosphamide at 30 mg/kg/day; for new donor-derived CAR T-cell infusion) will be administrated for 3 days. Then this study will be using BOIN1/2 approach from starting dose 1: 1×10\^6 (±20%) to dose 2: 2×10\^6 (±20%). If the manufactured cells were not sufficient to meet the preassigned standard dose criteria, patients are given infusion at a low dose of 5×10\^5 (±20%) /kg.
Timeline
- Start
- 2021-09-14
- Primary completion
- 2023-09-01
- Completion
- 2024-09-01
Outcome
Outcome not reported
Stopped: “ethic commitee decision”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD5CART | Cell therapy | 500000 cells/kg | — |
| Subject | CD5CART | Cell therapy | 1e+06 cells/kg | — |
| Subject | CD5CART | Cell therapy | 2e+06 cells/kg | — |