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

• Status: Active, not recruiting
• Trial end date: 2027-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allogene Therapeutics
• Treatments: Cyclophosphamide; Fludarabine

Criteria

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