NCT03939026

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

A Single-Arm, Open-Label, Phase 1 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 Lymphoma or Follicular Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Allogene Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsed/Refractory Large B Cell Lymphoma
• Relapsed/Refractory Follicular Lymphoma

Interventions

Type	Name	Description
GENETIC	ALLO-501	ALLO-501 is an allogeneic CAR T cell therapy targeting CD19
BIOLOGICAL	ALLO-647	ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
DRUG	Fludarabine	Chemotherapy for lymphodepletion
DRUG	Cyclophosphamide	Chemotherapy for lymphodepletion

Timeline

• Start date: 2019-05-01
• Primary completion: 2021-10-23
• Completion: 2025-01-28
• First posted: 2019-05-06
• Last updated: 2026-03-02

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study