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Intravenous Autologous CD19 CAR-T Cells for R/R B-ALL
Sponsor: National University of Malaysia
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
CD19 CAR-T CELLS
CD19 CAR-T cells will be administered after completion of the lymphodepletion chemotherapy.
Cyclophosphamide
Patients will receive lymphodepleting chemotherapy consisting of Cyclophosphamide 250 - 300 mg/m2/day IV(Day -5, Day -4, Day -3 ).
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