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RECRUITING
NCT03937544
PHASE2/PHASE3

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

Sponsor: National University of Malaysia

View on ClinicalTrials.gov

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

Official title: 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

Key Details

Gender

All

Age Range

13 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2019-03-19

Completion Date

2027-03-18

Last Updated

2025-05-29

Healthy Volunteers

No

Interventions

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 ).

Locations (1)

UKM Medical Centre

Bandar Tun Razak, Kuala Lumpur, Malaysia