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ACTIVE NOT RECRUITING
NCT03907852
PHASE1/PHASE2

Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer

Sponsor: TCR2 Therapeutics

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

gavo-cel

gavo-cel

DRUG

fludarabine

lymphodepletion chemotherapy

DRUG

cyclophosphamide

lymphodepletion chemotherapy

DRUG

Nivolumab

immuno-oncology agent

DRUG

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