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Clinical Trial 19960
Cancer Type: Malignant Hematology
Interventions:ALLO-501 (); ALLO-647 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
Study Type: Treatment
Phase of Study: Phase I/II
Investigators:
- Frederick Locke
Study Title
A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501, an Anti-Cd19 Allogeneic Car T Cell Therapy in Patients with Relapsed/Refractory Large B-Cell and Follicular Lymphoma
Summary
Objective
Primary Objectives Phase 1: To assess safety and tolerability at increasing dose levels of ALLO-501 in successive cohorts of patients with relapsed/refractory large B-cell lymphoma or follicular lymphoma to estimate the maximum tolerated dose (MTD) of ALLO-501 administered following lymphodepletion with fludarabine/cyclophosphamide (Flu/Cy) and ALLO-647, and select the RP2D of ALLO-501. - To assess safety and tolerability of ALLO-647 in combination with Flu/Cy prior to ALLO-501 to confirm the dose of ALLO-647. Phase 2: To assess clinical efficacy of ALLO-501.