Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma

Phase 1 Completed 50 enrolled Allogene Therapeutics

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2019-05-01
Primary completion: 2021-10-23
Completion: 2025-01-28

Publications

Locke FL, Munoz JL, Tees MT, Lekakis LJ, de Vos S, Nath R, Stevens DA, Malik SA, Shouse GP, Hamadani M, Oluwole OO, Perales MA, Miklos DB, Fisher PW, Feng A, Navale L, Le Gall JB, Neelapu SS. Allogeneic Chimeric Antigen Receptor T-Cell Products Cemacabtagene Ansegedleucel/ALLO-501 in Relapsed/Refractory Large B-Cell Lymphoma: Phase I Experience From the ALPHA2/ALPHA Clinical Studies. J Clin Oncol. 2025 May 10;43(14):1695-1705. doi: 10.1200/JCO-24-01933. Epub 2025 Feb 13.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	ALLO-501	Cell therapy	—	—
Subject	Alemtuzumab	Monoclonal antibody	—	—
Background	Cyclophosphamide	Other / unclassified	300 mg/m2	—
Background	Cyclophosphamide	Other / unclassified	500 mg/m2	—
Background	Fludarabine	Small molecule	30 mg/m2	—

Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma

Summary

Timeline

Publications

Drugs

Indications