Safety and Efficacy of ALLO-501 Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell or Follicular Lymphoma

Prior treatment

• ASCT within last 6 weeks or allogeneic HSCT within last 3 months prior to ALLO-647.
• Prior treatment with anti-CD19 therapy, any gene therapy, any genetically modified cell therapy or adoptive T cell therapy
• Systemic anticancer therapy within 2 weeks prior to study entry.
• On-going treatment with immunosuppressive agents.

Other illness

• Current or history of central nervous system (CNS) lymphoma.
• Active acute or chronic graft versus host disease (GvHD), or GvHD requiring immunosuppressive treatment within 4 weeks of enrollment.
• Any form of primary or acquired immunodeficiency (e.g., severe combined immunodeficiency disease).
• Current thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy.

Other

• Clinically significant CNS dysfunction.
• Patients unwilling to participate in an extended safety monitoring period

• Histological or cytological diagnosis of Large B-cell Lymphoma (LBCL) or Follicular Lymphoma.
• Relapse or refractory disease after at least 2 lines of chemotherapy
• At least 1 measurable lesion at time of screening.
• Eastern Cooperative Oncology Group Performance Status of 0 or 1.
• Adequate hematological, renal, liver, pulmonary, and cardiac functions.