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

Trial ID or NCT#

NCT05000450

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. - 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:
  1. - 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
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Investigator(s)

Surbhi Sidana, MD
Surbhi Sidana, MD
Blood and marrow transplant specialist, Hematologist-Oncologist
Assistant Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Contact us to find out if this trial is right for you.

Contact

Sharan Claire
650-721-4091

View on ClinicalTrials.gov