Overview

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