drugset / Trial / NCT06080191
Allogeneic Second-generation CD19-CAR T Cells for Pediatric Relapsed/Refractory B-ALL
NaSingle-groupOpen-labelTreatment
Summary
This is a phase I, open label study to evaluate the safety, identify the recommended dose (RD) and obtain preliminar evidence of the efficacy of allogeneic, CD19-directed Chimeric Antigen Receptor T (alloCAR-T) cells in pediatric and young adults patients with relapsed/refractory B-cell precursor Acute Lymphoblastic Leukemia (BCP-ALL).
Timeline
- Start
- 2024-04-28
- Primary completion
- 2026-06-30
- Completion
- 2041-06-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CD19-CAR_Lenti_ALLO | Cell therapy | 500000 cells/kg | — |
| Subject | CD19-CAR_Lenti_ALLO | Cell therapy | 1e+06 cells/kg | — |
| Subject | CD19-CAR_Lenti_ALLO | Cell therapy | 2e+06 cells/kg | — |
| Subject | CD19-CAR_Lenti_ALLO | Cell therapy | 3e+06 cells/kg | — |
| Subject | CD19-CAR_Lenti_ALLO | Cell therapy | 5e+06 cells/kg | — |