Safety and Efficacy of ALLO-605 an Anti-BCMA Allogeneic CAR T Cell Therapy in Patients With Relapsed/Refractory Multiple Myeloma
Stopped early · Phase 1/Phase 2
Conditions studied: Relapsed/Refractory Multiple Myeloma
In brief
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.
Key facts
- Study ID
- NCT05000450
- Run by
- Allogene Therapeutics
- People needed
- 6
- Starts
- 2021-06-06
- Expected to finish
- 2023-10-11
- Last updated by the study team
- 2024-06-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Sarah Cannon/Colorado Blood Cancer Institute — Denver, Colorado, United States
- St. David's South Austin Medical Center — Austin, Texas, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- Texas Transplant Institute — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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