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NCT04416984

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 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.

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Interventions

ALLO-501AGENETIC
ALLO-501A is an allogeneic CAR T cell therapy targeting CD19
ALLO-647BIOLOGICAL
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
FludarabineDRUG
Chemotherapy for lymphodepletion
CyclophosphamideDRUG
Chemotherapy for lymphodepletion

Study Locations

FacilityCityStateCountry
Banner MD Anderson Cancer CenterGilbertArizonaUnited States
Mayo Clinic HospitalPhoenixArizonaUnited States
City of HopeDuarteCaliforniaUnited States
UCLA Medical CenterLos AngelesCaliforniaUnited States
Stanford Cancer InstitutePalo AltoCaliforniaUnited States
Colorado Blood Cancer InstituteDenverColoradoUnited States
Yale School of MedicineNew HavenConnecticutUnited States
University of MiamiMiamiFloridaUnited States
Advent HealthOrlandoFloridaUnited States
Moffitt Cancer CenterTampaFloridaUnited States
Northside Hospital - AtlantaAtlantaGeorgiaUnited States
Augusta UniversityAugustaGeorgiaUnited States
Loyola University Medical CenterMaywoodIllinoisUnited States
Norton Cancer InstituteLouisvilleKentuckyUnited States
Karmanos Cancer InstituteDetroitMichiganUnited States
Memorial Sloan Kettering Cancer CenterNew YorkNew YorkUnited States
Providence Portland Medical CenterPortlandOregonUnited States
Allegheny General HospitalPittsburghPennsylvaniaUnited States
Avera MedicalSioux FallsSouth DakotaUnited States
Vanderbilt Ingram Cancer CenterNashvilleTennesseeUnited States
St. David's South Austin Medical CenterAustinTexasUnited States
Texas OncologyDallasTexasUnited States
MD Anderson Cancer Center - University of TexasHoustonTexasUnited States
Medical College of WisconsinMilwaukeeWisconsinUnited States
Princess Alexandra HospitalWoolloongabbaQueenslandAustralia
Monash Medical CentreClaytonVictoriaAustralia
St. Vincent's Hospital MelbourneFitzroyVictoriaAustralia
QEII Health Sciences Centre-VG SiteHalifaxNova ScotiaCanada
CHU de Québec -Université Laval; Hôpital de l'Enfant-JésusQuébecQuebecCanada

Official Trial Information

View on ClinicalTrials.gov

Data sourced from ClinicalTrials.gov. Last updated: April 14, 2026