LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T Lymphocyte Tumor
Summary
This is a multicenter phase I clinical study evaluating the safety, tolerability, and efficacy of LCAR-T2C cell agents targeting CD4 in patients with relapsed/refractory CD4-positive T lymphocytic tumors. Thirty-three subjects will be enrolled. Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 5 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m2( body surface area) and cyclophosphamide 300 mg/m2( body surface area) for 3 days. hen this study will be using a 3+3 dose escalation approach from dose 1 (DL-1): 5×105 to dose 2 (dl-2): 1.5×106 , to dose 3 (dl-3): 5×106 to dose 4 (dl-4): 10.0×106. Below the lowest dose was reinfused at the PI's discretion.
Timeline
- Start
- 2021-07-02
- Primary completion
- 2022-07-11
- Completion
- 2022-07-20
Outcome
Outcome not reported
Stopped: “Both the sponsors and collaborator are considering terminating the study”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LCAR-T2C | Cell therapy | 500000 cells | — |
| Subject | LCAR-T2C | Cell therapy | 1.5e+06 cells | — |
| Subject | LCAR-T2C | Cell therapy | 5e+06 cells | — |
| Subject | LCAR-T2C | Cell therapy | 1e+07 cells | — |