NCT05714345

Evaluation of Lymphodepletion With ALLO-647 in Adults With R/R Large B Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy

A Randomized, Open-Label, Phase 2 Study Evaluating Lymphodepletion With ALLO-647, Fludarabine, and Cyclophosphamide, vs. Fludarabine and Cyclophosphamide Alone, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma Receiving ALLO-501A Allogeneic CAR T Cell Therapy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Allogene Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the EXPAND study is to assess the safety and clinical efficacy of ALLO-647 combined with fludarabine and cyclophosphamide compared to fludarabine and cyclophosphamide alone in a lymphodepletion regimen prior to ALLO-501A CAR T therapy in adults with relapsed or refractory large B-cell lymphoma

Conditions

• Relapsed/Refractory Large B Cell Lymphoma

Interventions

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

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-02-20
• Completion: 2024-10-28
• First posted: 2023-02-06
• Last updated: 2026-03-02
• Results posted: 2025-12-31

Locations

2 sites across 2 countries: United States, Belgium

Regulatory

• FDA-regulated drug study