drugset / Trial / NCT05266950
Safety and Efficacy Study of CI-135 CAR-T Cells in Subjects with Relapsed or Refractory Acute Myeloid Leukemia
NaSingle-groupOpen-labelTreatment
Summary
This is a FIH, single center, open label, non-randomized, single-arm, Phase I clinical trial to evaluate the safety and efficacy of CI-135 CAR-T cells in subjects with relapsed or refractory Acute Lymphoblastic Leukemia. This study is a dose-escalation study that includes 2 dose levels, and a total of 4-7 subjects will be enrolled. CI-135 CAR-T cells will be manufactured using PBMC collected from the subjects, and will be infused intravenously into subjects after lymphodepletion.
Timeline
- Start
- 2021-12-13
- Primary completion
- 2023-12-12
- Completion
- 2023-12-12
Outcome
Outcome not reported
Stopped: “Difficulty in joining the group”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CI-135 | Cell therapy | 0.5 cells/kg | Intravenous |
| Subject | CI-135 | Cell therapy | 1 cells/kg | Intravenous |