The purpose of the ALPHA study is to assess the safety, efficacy, cell kinetics and immunogenicity of ALLO-501 in adults with relapsed or refractory large B-cell lymphoma or follicular lymphoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, and ALLO-647.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
ALLO-501 is an allogeneic CAR T cell therapy targeting CD19
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Chemotherapy for lymphodepletion
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
Stanford University
Stanford, California, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Moffitt Cancer Center
Tampa, Florida, United States
Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-501
Dose limiting toxicity is defined as protocol-defined ALLO-501-related adverse events with onset within 28 days following infusion
Time frame: 28 days
Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-501
Dose-limiting toxicity is defined as protocol-defined ALLO-647-related adverse events with onset within 33 days following 1st infusion
Time frame: 33 days
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Chemotherapy for lymphodepletion
Norton Cancer Institute
Louisville, Kentucky, United States
St. Davids South Austin Medical Center
Austin, Texas, United States
MD Anderson
Houston, Texas, United States