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

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

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

Exclusion Criteria:

• Active central nervous system involvement by malignancy
• Autologous or allogeneic HSCT within last 6 months prior to lymphodepletion
• Hypocellular bone marrow for age