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

• Status: Not yet recruiting
• Trial end date: 2029-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: 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

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

• ECOG performance status 0 or 1

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

• Adequate hematological, renal and liver function

• Lactic acid dehydrogenase ≤2 x ULN

Exclusion Criteria:

• Active central nervous system involvement by malignancy

• Autologous or allogeneic HSCT within last 6 months prior to lymphodepletion

• Prior treatment with anti-CD19 targeted therapies

• Hypocellular bone marrow for age