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Safety and Efficacy of ALLO-715 BCMA Allogenic CAR T Cells in in Adults With Relapsed or Refractory Multiple Myeloma (UNIVERSAL)
Sponsor: Allogene Therapeutics
Summary
The purpose of the UNIVERSAL study is to assess the safety, efficacy, cell kinetics, and immunogenicity of ALLO-715 with or without Nirogacestat in adults with relapsed or refractory multiple myeloma after a lymphodepletion regimen of ALLO-647 in combination with fludarabine and/or cyclophosphamide, or ALLO-647 alone.
Official title: A Single-Arm, Open-Label, Phase 1 Study of the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-715 to Evaluate an Anti-BCMA Allogeneic CAR T Cell Therapy With or Without Nirogacestat in Subjects With Relapsed/Refractory Multiple Myeloma
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2019-09-23
Completion Date
2027-09
Last Updated
2023-08-14
Healthy Volunteers
No
Conditions
Interventions
ALLO-715
ALLO-715 is an allogeneic CAR T cell therapy targeting BCMA
ALLO-647
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Fludarabine
Chemotherapy for lymphodepletion
Cyclophosphamide
Chemotherapy for lymphodepletion
Nirogacestat
a small molecule, selective, reversible, noncompetitive inhibitor of γsecretase (GSI) that increases BCMA target density on the surface of multiple myeloma cells.
Locations (11)
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
City of Hope
Duarte, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
Sarah Cannon/Colorado Blood Cancer Institute
Denver, Colorado, United States
Mayo Clinic
Rochester, Minnesota, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
St. David's South Austin Medical Center
Austin, Texas, United States
Texas Transplant Institute
San Antonio, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States