drugset / Trial / NCT06635330
Safety and Efficacy of CAR T Cell Therapy in Patients with R/r B-ALL
NaSingle-groupOpen-labelTreatment
Summary
The goal of this clinical trial is to evaluate the safety and efficacy of CD19 CAR-T cells in pediatric patients of all genders, aged 2 to 18 years, with relapsing or refractory B cell acute lymphoblastic leukemia (r/r B-ALL). The main questions it aims to answer are as following: 1. What is the percentage of patients with overall remission rate (ORR) of complete response (CR) or complete remission with incomplete blood count recovery (CRi)? 2. What is the rate of Event-free survival at first month and 2-3 months after intervention? 3. What is the rate of Overall survival at first month and at 3 months after the intervention?
Timeline
- Start
- 2024-05-20
- Primary completion
- 2026-09-22
- Completion
- 2027-09-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | anti-CD19 CAR T cell therapy | Cell therapy | 200000 cells/kg | — |
| Subject | anti-CD19 CAR T cell therapy | Cell therapy | 5e+06 cells/kg | — |
| Subject | anti-CD19 CAR T cell therapy | Cell therapy | 1e+07 cells | — |
| Subject | anti-CD19 CAR T cell therapy | Cell therapy | 2.5e+08 cells | — |