drugset / Trial / NCT05114837
Ph I/II Study of CAR19 Regulatory T Cells (CAR19-tTreg) for R/R CD19+ B-ALL
NaSingle-groupOpen-labelTreatment
Summary
This is a single-center, single-arm, interventional phase I/II trial to evaluate the safety profile and potential efficacy of allogeneic CAR19 regulatory T cells (CAR19-tTreg) in adults with relapsed/refractory (R/R) CD19+ B Acute Lymphocytic Leukemia (B-ALL). The study consists of two components. The dose finding component is a modified version of a Phase I trial and the extended component is a modified Phase II trial.
Timeline
- Start
- 2024-09
- Primary completion
- 2028-08
- Completion
- 2028-08
Outcome
Outcome not reported
Stopped: “replaced with a new IND and protocol”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CAR19-tTreg | Cell therapy | 1e+06 cells/kg | — |
| Subject | CAR19-tTreg | Cell therapy | 3e+06 cells/kg | — |
| Subject | CAR19-tTreg | Cell therapy | 1e+07 cells/kg | — |
| Subject | CAR19-tTreg | Cell therapy | 3e+07 cells/kg | — |
| Background | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Background | Fludarabine | Small molecule | 30 mg/m2 | Intravenous |