Clinical Trial

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)

Study acronym: ALPHA2
Active, Not Recruiting Phase 1/2
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Summary
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.
Protocol Amendment History 13 amendments
This ClinicalTrials.gov record has been amended 13 times since 2020-06-02; most recent amendment 2026-03-03.
Status change: Recruiting → Active, Not Recruiting 2025-01-22
Status change: Active, Not Recruiting → Recruiting 2022-03-31
Status change: Recruiting → Active, Not Recruiting 2021-10-13
Trial Details
NCT Number NCT04416984
Lead Sponsor Allogene Therapeutics
Conditions Relapsed or Refractory Large B Cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma
Enrollment 160 participants
Start Date 2020-05-21
Primary Completion 2029-02 (estimated)
Study Completion 2029-05 (estimated)
Updated on ClinicalTrials.gov 2026-03-04