drugset / Trial / NCT04173988

Study of alloCART-19 Cell Therapy in Pediatric Patients With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia

NCT04173988

Phase 0 Unknown 6 enrolled Children's Hospital of Fudan University
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

EvaluationDrugModalityDoseRoute
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