A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmocodynamics of ALLO-501A, an Anti-CD19 Allogeneic Car T Cell Therapy in Subjects with Relapsed/Refractory Large B-Cell Lymphoma (LBCL)
The purpose of the ALPHA-2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell 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-501A in successive cohorts of subjects with relapsed/refractory (R/R) LBCL to estimate the maximum tolerated dose (MTD) of ALLO-501A administered following lymphodepletion with fludarabine/cyclophosphamide (Flu/Cy) and ALLO-647 and to select the recommended Phase 2 dose (RP2D) of ALLO-501A -To assess safety and tolerability of ALLO-647 in combination with Flu/Cy prior to ALLO-501A and to establish the RP2D of ALLO-647. Phase 2: -to assess clinical efficacy of ALLO-501A as measured by overall response rate (ORR) and assessed by Independent Radiology Review (IRR) in subjects with R/R/ LBCL. Secondary Objectives (Phase 1 and 2) -to evaluate the overall safety profile of ALLO-501A and ALLO-647 in combination with Flu/Cy -to evaluate anti-tumor activity of ALLO-501A (Phase 2 only) -To characterize cellular kinetics of ALLO-501A -to characterize the pharmacokinetics of ALLO-647 -to evaluate immunogenicity against ALLO-501A and ALLO-647 -to evaluate host immune cell depletion and reconstitution resulting from lymphodepletion with ALLO-647 in combination with Flu/Cy prior to ALLO-501A Exploratory Objectives (Phase 1 and 2) -to explore potential biomarker development based on assessment of blood cells and tumor cells for ALLO-501A and ALLO-647 -to explore changes in immunoregulatory transcripts (RNA profile) and T cell clonal diversity (TCR DNA sequencing) and its relationship to ALLO-501A expansion, persistence, and activity -to explore the impact of ALLO-501A on systemic soluble immune factors -to collect banked biospecimens for exploratory research, unless prohibited by local regulations or ethics committee decision -to assess MRD negativity -to explore the safety and efficacy of retreatment with ALLO-501A following lymphodepletion
ALLO-501A (); ALLO-647 (); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
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