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drugset / Trial / NCT03937544

Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL

NCT03937544 ↗

Phase 2/3 Recruiting 10 enrolled National University of Malaysia Gaia Science · collab
NaSingle-groupOpen-labelTreatment

Summary

This is Phase II / III, Prospective, single arm, Open Label Study to Evaluate Safety and Efficacy of Intravenous Autologous CD19 CAR-T Cells for Relapsed / Refractory B-Acute Lymphoblastic Leukaemia

Timeline

Start
2019-03-19
Primary completion
2027-01-18
Completion
2027-03-18

Drugs

EvaluationDrugModalityDoseRoute
Subject CD19 CAR-T cells Cell therapy — Intravenous
Background Cyclophosphamide Other / unclassified 250 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 300 mg/m2 Intravenous
Background Fludarabine Small molecule 25 mg/m2 Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous

Indications

B-cell acute lymphoblastic leukemia precursor B-cell acute lymphoblastic leukemia