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

Allogene Therapeutics

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Relapsed/Refractory Multiple Myeloma

Treatments

Drug: Fludarabine

Drug: Cyclophosphamide

Genetic: ALLO-605

Biological: ALLO-647

Study type

Interventional

Funder types

Industry

Identifiers

NCT05000450

IGNITE Study (Other Identifier)

ALLO-605-201

Details and patient eligibility

About

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.

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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