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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

Lymphoma, Mantle-Cell

Mantle Cell Lymphoma

Interleukin-4

BAFFR-CAR T cells in participants with r/r B-NHL

First-in-human trial examining the safety and preliminary efficacy of BAFFR-CAR T cells in participants with r/r B-NHL

BAFFR-CAR T cells

Hazel (Ting-Ying) Cheng, PhD

Katrin Tiemann, PhD

Elizabeth Budde, MD

A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients with Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)

This phase I trial evaluates the side effects and best dose of BAFFR-CAR T cells in treating patients with B-cell Non-Hodgkin's Lymphoma (B-NHL) that has come back (recurrent) or does not respond to treatment (refractory). T cells are infection fighting blood cells that can kill cancer cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize BAFFR, a protein on the surface of cancer cells. These BAFFR-specific T cells may help the body's immune system identify and kill BAFFR+ cancer cells.

BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-NHL

A Phase 1 Study Evaluating BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma (B-NHL)

Assess the safety of administering BAFFR-CAR T cells in participants with relapsed or refractory (r/r) B-cell Non-Hodgkin's Lymphoma (B-NHL) and it's subtypes. Toxicity will be graded per Common Terminology Criteria for Adverse Events version 5.0, Cytokine Release Syndrome (CRS) and neurotoxicity which use the American Society for Transplantation and Cellular Therapy Consensus Criteria (ASTCT) and Graft versus Host Disease (GVHD) criteria. Toxicities will be followed from the start of lymphodepletion until the end of the study.

Determine the maximum tolerated dose (MTD)/recommended Phase 2 dose (RP2D) of BAFFR-CAR T cells. Toxicity will be graded per Common Terminology Criteria for Adverse Events version 5.0, Cytokine Release Syndrome (CRS) and neurotoxicity which use the American Society for Transplantation and Cellular Therapy Consensus Criteria (ASTCT) and Graft versus Host Disease (GVHD) criteria. Toxicities will be followed from the start of lymphodepletion until the end of the study.

Defined as achieving a best response of complete response or partial response per Lugano Criteria

Negative MRD is defined by malignant cells \< 0.01% by flow cytometry or clonoSEQ.

Kaplan-Meier product limit method with log-log transformation for the confidence interval will be used to estimate PFS.

Kaplan-Meier product limit method with log-log transformation for the confidence interval will be used to estimate OS.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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)	NCT04416984	Relapsed or Ref...	ALLO-501A ALLO-647 Fludarabine Cyclophosphamid...	18 Years -	Allogene Therapeutics
BAFFR-targeting CAR T Cells for Patients With Relapsed or Refractory B-NHL	NCT05370430	Relapsed or Ref...	BAFFR-CAR T cel...	18 Years -	PeproMene Bio, Inc.

Spots Global Cancer Trial Database for lbcl

Every month we try and update this database with for lbcl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for lbcl

Every month we try and update this database with for lbcl cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for lbcl cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.