Open Actively Recruiting
Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma (ALPHA2)
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.
- 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.
- Current or history of central nervous system (CNS) lymphoma.
- 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
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