Study Summary
This is a single-arm, open-label, phase I study (safety and dose escalation) of autologous Chimeric Antigen Receptor (CAR) T-cells targeting CD19 in patients with relapsed/refractory B cell acute lymphoblastic leukemia (ALL).
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Request More InfoInterventions
CD19 CAR engineered autologous T-cellsBIOLOGICAL
Given IV
Following preconditioning with lymphodepleting chemotherapy (cyclophosphamide and fludarabine) patients will be treated with CD19 Chimeric Antigen Receptor (CAR) T cells as a single or split dose (day 0, 1 and 2, CAR cells will be intravenously infused at the 10%, 30% and 60% ratio respectively). Dosing of CD19 CAR-T cells will follow a dose-escalation schema, with dose changes based on dose-limiting toxicities.
CyclophosphamideDRUG
Given IV
FludarabineDRUG
Given IV
MesnaDRUG
Given IV
Study Locations
| Facility | City | State | Country |
|---|---|---|---|
| Gene therapy research center, Shariati hospital, Tehran university of medical sciences, Iran | Tehran | Iran | |
| Research Institute for Oncology- Hematology and Cell Therapy (RIOHCT), Tehran University of Medical Sciences | Tehran | Iran |