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Brief Title: 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)
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)
Study ID: NCT04416984
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
The Alfred Hospital, Melbourne, Victoria, Australia
Vancouver General Hospital, Vancouver, British Columbia, Canada
QEII Health Sciences Centre-VG Site, Halifax, Nova Scotia, Canada
CHU de Québec -Université Laval; Hôpital de l'Enfant-Jésus, Québec, , Canada
Azienda Ospedaliero-Universitaria di Bologna - Policlinico Sant Orsola-Malpighi, Bologna, , Italy
Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) - Ospedale San Raffaele, Milan, , Italy
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino, Torino, , Italy
Hospital Universitari Vall d'Hebrón, Barcelona, , Spain
Hospital Universitario Donostia, Donostia-San Sebastian, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario La Paz, Madrid, , Spain
Complot Asistencial Universitario de Salamanca - Hospital Clínico, Salamanca, , Spain