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ALLO-501A is an allogeneic CAR T cell therapy targeting CD19

ALLO-501A

ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen

ALLO-647

Allogene Therapeutics Inc.

Yasmin Adam

Tiffany Tran

Geoffrey Shouse, MD

Christopher Hannigan

Linnea Nichols

Ben Burtness

Rushang Patel, MD

Rebecca Delph

Caitlin Guzowski

Kelly Jenkins

Rachel Martino

Ashley Spalding

Grace Bae

Olalekan Oluwole, MD

Tiffany Cardona

Christine Terraciano

Swapna Binoy

This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in adult subjects with R/R LBCL and CLL/SLL. The purpose of the ALPHA2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma and assess the safety of ALLO-501A in adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma, Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (ALPHA2)

A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501A, an Anti-CD19 Allogeneic CAR T Cell Therapy, and ALLO-647, an Anti-CD52 Monoclonal Antibody, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma (LBCL)

Dose limiting toxicity is defined as protocol-defined ALLO-501A-related adverse events with onset within 28 days following infusion

DLT is defined as protocol-defined ALLO-647-related adverse events with onset within 33 days following 1st infusion

ORR defined as assessment of CR and PR using Lugano classification criteria 2014

DOR is defined only for subjects who experience an objective response and is the time from the first objective response to disease progression or death, whichever comes first per (Cheson et al, 2014)

CR Complete Response, PR Partial Response, SD Stable Disease, PD Progressive Disease

PFS, defined as time from the enrollment date to progression, relapse, or death

TTR, defined as the time from the enrollment date to the first observed response

OS, defined as the time from the enrollment date to death

The incidence and severity of Cytokine Release Syndrome (CRS), Graft-Versus-Host Disease (GVHD), infections, cytopenias, and neurotoxicity

The incidence of infusion-related reactions, cytopenias, and infections

Allogene Therapeutics

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