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Brief Title: Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer
Official Title: A Phase 1/2 Single Arm Open-Label Clinical Trial of Gavocabtagene Autoleucel (Gavo-cel) in Patients With Advanced Mesothelin-Expressing Cancer
Study ID: NCT03907852
Brief 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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