Multiple Myeloma Clinical Trial

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

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.

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Eligibility 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

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

136

Study ID:

NCT05000450

Recruitment Status:

Active, not recruiting

Sponsor:

Allogene Therapeutics

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There are 3 Locations for this study

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St. David's South Austin Medical Center
Austin Texas, 78704, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Texas Transplant Institute
San Antonio Texas, 78229, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 1

Estimated Enrollment:

136

Study ID:

NCT05000450

Recruitment Status:

Active, not recruiting

Sponsor:


Allogene Therapeutics

How clear is this clinincal trial information?

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