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, and ALLO-647, an Anti-CD52 Monoclonal Antibody, in Patients with Relapsed/Refractory Large B-Cell and Follicular Lymphoma
The purpose of the ALPHA study is to assess the safety, efficacy, cell kinetics and immunogenicity of ALLO-501 in adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
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.
Immunotherapy; Therapy (NOS)
ALLO-501 (); ALLO-647 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
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