This is a Phase 1 dose escalation study following a 3+3 study design. The purpose of the TRAVERSE study is to assess the safety, efficacy, and cell kinetics of ALLO-316 in adults with advanced or metastatic clear cell renal cell carcinoma after a lymphodepletion regimen comprising fludarabine, cyclophosphamide, with or without ALLO-647 to define a Phase 2 dose.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
ALLO-316 is an allogeneic CAR T cell therapy targeting CD70
ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
Chemotherapy for lymphodepletion
City of Hope
Duarte, California, United States
UCLA Medical Center
Los Angeles, California, United States
UCSF Medical Center
San Francisco, California, United States
Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of ALLO-316
Time frame: 28 days
Proportion of patients experiencing Dose Limiting Toxicity with ALLO-647 in combination with fludarabine/cyclophosphamide administered prior to ALLO-316
Time frame: 33 days
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Chemotherapy for lymphodepletion
Yale School of Medicine
New Haven, Connecticut, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Moffitt Cancer Center
Tampa, Florida, 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
MD Anderson Cancer Center
Houston, Texas, United States