Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma (ALPHA-2)

• Status: Active, not recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the ALPHA-2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allogene Therapeutics
• Treatments: Cyclophosphamide; Fludarabine

Criteria

Inclusion Criteria:

• Histologically confirmed diagnosis of relapsed/refractory large B-cell lymphoma at last relapse.

• At least 1 measurable lesion at time of enrollment.

• Relapsed or refractory disease after at least 2 lines of chemotherapy

• ECOG performance status 0 or 1.

• Absence of donor (product)-specific anti-HLA antibodies (DSA).

• Adequate hematological, renal and liver function.

Exclusion Criteria:

• Current or history of central nervous system (CNS) lymphoma.

• Clinically significant CNS dysfunction

• Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ.

• Radiation therapy within 2 weeks prior to ALLO-647.

• Prior irradiation to >25% of the bone marrow.

• Donor lymphocyte infusion (DLI) within 30 days prior to ALLO-647.

• Patients unwilling to participate in an extended safety monitoring period