drugset / Trial / NCT04173988
Study of alloCART-19 Cell Therapy in Pediatric Patients With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to evaluate the safety and tolerability of CD19-Directed Allogeneic Chimeric Antigen Receptor T- cell (alloCART-19)therapy in pediatric patients with relapsed/refractory acute lymphoblastic leukemia(ALL).
Timeline
- Start
- 2020-01-09
- Primary completion
- 2024-10-20
- Completion
- 2025-07-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | alloCART-19 | Cell therapy | 500000 cells/kg | Intravenous |
| Subject | alloCART-19 | Cell therapy | 5e+06 cells/kg | Intravenous |
| Subject | alloCART-19 | Cell therapy | 2.5e+07 cells | Intravenous |
| Subject | alloCART-19 | Cell therapy | 2.5e+08 cells | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Fludarabine | Small molecule | — | — |