Study Summary
* Brief Summary: Cluster of differentiation 19 (CD19) is expressed on B cells. CD19+ tumor cells in patients with non-Hodgkin lymphoma and acute lymphoblastic leukemia can be targeted using T cells expressing CD19-specific chimeric antigen receptor (CAR). * Objective: This study aims to evaluate the safety and efficacy of single-dose anti-CD19 CAR T-cell therapy in the treatment of relapsed/refractory CD19+ non-Hodgkin lymphoma and acute lymphoblastic leukemia. * Eligibility: People aged 1 to 60 years with relapsed/refractory CD19+ non-Hodgkin lymphoma and acute lymphoblastic leukemia. * Design: Phase 1 clinical trial, uncontrolled, single dose of CD19 CAR T-cells.
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Request More InfoInterventions
anti-CD19 CAR T-cellsBIOLOGICAL
For Biological: CD19 CAR T-cells
* Dose: 1-2.10e6 cells/kg of weight
* Route: intravenous infusion
For Chemotherapy Drug:
* Fludarabine (30 mg/m2/day) given intravenously (IV) on day -5 to -3.
* Cyclophosphamide 500 mg/m2/day for NHL and 250 mg/m2/day for ALL given IV from day -5 to -3.
* Mesna 500 mg/m2/day for NHL and 250 mg/m2/day for ALL, divided in three infusions: one day before the cyclophosphamide infusion, and 4 and 8 hours after.
Study Locations
| Facility | City | State | Country |
|---|---|---|---|
| Vinmec Research Institute of Stem Cell and Gene Technology | Hanoi | Hanoi | Vietnam |