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

Not Recruiting

Trial ID: NCT05000450

Purpose

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.

Official Title

A Single-Arm, Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-647 and ALLO-605, an Anti- BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma

Stanford Investigator(s)

Surbhi Sidana, MD
Surbhi Sidana, MD

Assistant Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Eligibility

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

Intervention(s):

genetic: ALLO-605

biological: ALLO-647

drug: Fludarabine

drug: Cyclophosphamide

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sharan Claire
650-721-4091

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