drugset / Trial / NCT06635330

Safety and Efficacy of CAR T Cell Therapy in Patients with R/r B-ALL

NCT06635330 ↗

Phase 1/2 Recruiting 5 enrolled Kara Yakhteh Tajhiz Azma Company
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

EvaluationDrugModalityDoseRoute
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 —