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.

SparkCures ID	1208
Trial Phase	Phase 1/2
Enrollment	136 Patients
Treatments	ALLO-605 ALLO-647 Cyclophosphamide Fludarabine
Tags	B-Cell Maturation Antigen (BCMA) CAR T Cell (Allogeneic)
Trial Sponsors	Allogene Therapeutics
NCT Identifier	NCT05000450

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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

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

Overview

Am I Eligible?

US Trial Locations

Trial Links

FDA grants orphan drug designation to off-the-shelf CAR-T for advanced multiple myeloma