NCT03937544

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

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: National University of Malaysia · Academic / Other
• Sex: All
• Age: 13 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Relapsed B Acute Lymphoblastic Leukaemia
• Refractory B Acute Lymphoblastic Leukaemia

Interventions

Type	Name	Description
BIOLOGICAL	CD19 CAR-T CELLS	CD19 CAR-T cells will be administered after completion of the lymphodepletion chemotherapy.
DRUG	Cyclophosphamide	Patients will receive lymphodepleting chemotherapy consisting of Cyclophosphamide 250 - 300 mg/m2/day IV(Day -5, Day -4, Day -3 ).
DRUG	Fludarabine	Patients will receive lymphodepleting chemotherapy consisting of Fludarabine 25-30 mg/m2/day IV (Day -5, Day -4, Day -3 ).

Timeline

• Start date: 2019-03-19
• Primary completion: 2027-01-18
• Completion: 2027-03-18
• First posted: 2019-05-03
• Last updated: 2025-05-29

Locations

1 site across 1 country: Malaysia