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Safety and Efficacy of ALLO-501A Anti-CD19 Allogeneic CAR T Cells in Adults With Relapsed/Refractory Large B Cell Lymphoma, Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma (ALPHA2)
Sponsor: Allogene Therapeutics
Summary
This is a single-arm, open label, multicenter Phase 1/2 study evaluating ALLO-501A in adult subjects with R/R LBCL and CLL/SLL. The purpose of the ALPHA2 study is to assess the safety, efficacy, and cell kinetics of ALLO-501A in adults with relapsed or refractory large B-cell lymphoma and assess the safety of ALLO-501A in adults with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) 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-501A, an Anti-CD19 Allogeneic CAR T Cell Therapy, and ALLO-647, an Anti-CD52 Monoclonal Antibody, in Subjects With Relapsed/Refractory Large B-Cell Lymphoma (LBCL)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2020-05-21
Completion Date
2029-05
Last Updated
2026-03-04
Healthy Volunteers
No
Interventions
ALLO-501A
ALLO-501A is an allogeneic CAR T cell therapy targeting CD19
ALLO-647
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Fludarabine
Chemotherapy for lymphodepletion
Cyclophosphamide
Chemotherapy for lymphodepletion
Locations (29)
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Mayo Clinic Hospital
Phoenix, Arizona, United States
City of Hope
Duarte, California, United States
UCLA Medical Center
Los Angeles, California, United States
Stanford Cancer Institute
Palo Alto, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Yale School of Medicine
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
Advent Health
Orlando, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northside Hospital - Atlanta
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Loyola University Medical Center
Maywood, Illinois, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Providence Portland Medical Center
Portland, Oregon, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Avera Medical
Sioux Falls, South Dakota, United States
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, United States
St. David's South Austin Medical Center
Austin, Texas, United States
Texas Oncology
Dallas, Texas, United States
MD Anderson Cancer Center - University of Texas
Houston, Texas, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Monash Medical Centre
Clayton, Victoria, Australia
St. Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
QEII Health Sciences Centre-VG Site
Halifax, Nova Scotia, Canada
CHU de Québec -Université Laval; Hôpital de l'Enfant-Jésus
Québec, Quebec, Canada