Gavocabtagene autoleucel (gavo-cel; TC-210) is a novel cell therapy that consists of autologous genetically engineered T cells expressing a single-domain antibody that recognizes human Mesothelin, fused to the CD3-epsilon subunit which, upon expression, is incorporated into the endogenous T cell receptor (TCR) complex. This Phase 1/2 study aims to establish the recommended Phase 2 dose (RP2D) and subsequently evaluate the efficacy of gavo-cel, with and without immuno-oncology agents, in patients with advanced mesothelin-expressing cancers, with overall response rate and disease control rate as the primary Phase 2 endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
57
gavo-cel
lymphodepletion chemotherapy
lymphodepletion chemotherapy
immuno-oncology agent
immuno-oncology agent
University of California, San Francisco
San Francisco, California, United States
University of Miami Sylvester Cancer Center
Miami, Florida, United States
University of Chicago Medical Center
Chicago, Illinois, United States
National Cancer Institute
Bethesda, Maryland, United States
Columbia University Medical Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University
Durham, North Carolina, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
SCRI Oncology Partners
Nashville, Tennessee, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
...and 1 more locations
Phase 1- Primary Objective
Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events.
Time frame: DLTs within 28 days post-treatment
Phase 2- Primary Objective
To evaluate the efficacy of autologous genetically modified T cells (gavo-cel), with or without immuno-oncology agents, in patients with MSLN-expressing unresectable, metastatic, or recurrent cancers as determined by overall response rate and disease control rate using RECIST v1.1 (or mesothelioma-specific RECIST criteria, if applicable).
Time frame: ORR at 3 months; DCR based on ORR + SD lasting at least 8 weeks
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