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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
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