Safety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma

A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-647 and ALLO-605, an Anti- BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma

The purpose of the ALLO-605-201 study is to assess the safety, efficacy, and cell kinetics of ALLO605 in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.

Inclusion Criteria:

• Documented diagnosis of relapsed/refractory multiple myeloma (MM)
• Subjects must have measurable disease
• Subjects must have received ≥3 prior MM lines of therapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate hematologic, renal, liver, pulmonary, and cardiac functions
• Life expectancy of at least 3 months without treatment

Exclusion Criteria:

• Subjects with known active or history of central nervous system (CNS) or leptomeningeal involvement of myeloma or plasma cell leukemia
• Current or history of thyroid disorder (including hyperthyroidism), except for subjects with hypothyroidism controlled on a stable dose of hormone replacement therapy
• Autologous stem cell transplantation within last 6 weeks prior to the start of lymphodepletion
• Any prior allogeneic hematopoietic stem cell transplantation
• Systemic anti-cancer therapy within 2 weeks prior to the start of lymphodepletion