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Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer
Sponsor: TCR2 Therapeutics
Summary
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.
Official title: A Phase 1/2 Single Arm Open-Label Clinical Trial of Gavocabtagene Autoleucel (Gavo-cel) in Patients With Advanced Mesothelin-Expressing Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
57
Start Date
2019-04-15
Completion Date
2028-11-02
Last Updated
2025-08-27
Healthy Volunteers
No
Conditions
Interventions
gavo-cel
gavo-cel
fludarabine
lymphodepletion chemotherapy
cyclophosphamide
lymphodepletion chemotherapy
Nivolumab
immuno-oncology agent
Ipilimumab
immuno-oncology agent
Locations (11)
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
Princess Margaret Cancer Centre
Toronto, Ontario, Canada