Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer
NCT ID: NCT03907852
Last Updated: 2025-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
57 participants
INTERVENTIONAL
2019-04-15
2028-11-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Lymphodepletion followed by gavo-cel
fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel
gavo-cel
gavo-cel
fludarabine
lymphodepletion chemotherapy
cyclophosphamide
lymphodepletion chemotherapy
Lymphodepletion followed by gavo-cel plus nivolumab
fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel with nivolumab 360mg every 3 weeks starting on Day 21 post gavo-cel
gavo-cel
gavo-cel
fludarabine
lymphodepletion chemotherapy
cyclophosphamide
lymphodepletion chemotherapy
Nivolumab
immuno-oncology agent
Lymphodepletion followed by gavo-cel plus nivolumab and ipilimumab
fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel with nivolumab 360mg every 3 weeks starting on Day 21 post gavo-cel and ipilimumab 1mg/kg every 6 weeks starting on Day 42 post gavo-cel
gavo-cel
gavo-cel
fludarabine
lymphodepletion chemotherapy
cyclophosphamide
lymphodepletion chemotherapy
Nivolumab
immuno-oncology agent
Ipilimumab
immuno-oncology agent
Interventions
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gavo-cel
gavo-cel
fludarabine
lymphodepletion chemotherapy
cyclophosphamide
lymphodepletion chemotherapy
Nivolumab
immuno-oncology agent
Ipilimumab
immuno-oncology agent
Eligibility Criteria
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Inclusion Criteria
* Patient has a pathologically confirmed diagnosis of either Malignant Pleural/Peritoneal Mesothelioma (MPM), Serous Ovarian Adenocarcinoma, Cholangiocarcinoma, or Non-Small Cell Lung Cancer (NSCLC) at screening.
* Patient's tumor has been pathologically reviewed by the central laboratory. For Serous Ovarian Adenocarcinoma, patients must have confirmed positive MSLN expression on \>/= 30% of tumor cells that are 1+, 2+, and/or 3+ by immunohistochemistry (IHC). Ovarian patients will subsequently be stratified into two groups: high MSLN expression (\>/= 50% of tumor cells that are 2+ and/or 3+) or low MSLN expression (\>/= 30% of tumor cells that are 1+, 2+, and/or 3+ not meeting criteria for the high MSLN expression group). MPM patients must have MSLN expression of \>/= 50% of tumor cells that are 2+ and/or 3+ by IHC. Cholangiocarcinoma and NSCLC patients must have MSLN expression of \>/= 30% of tumor cells that are 1+, 2+, and/or 3+ by IHC.
* Prior to gavo-cel infusion, patients must have received at least 1 systemic standard of care therapy for metastatic or unresectable disease, with the exception of Cholangiocarcinoma patients who may have elected not to pursue standard frontline therapy. Regardless of tumor type, patients must not exceed 5 prior lines of therapy (excluding bridging therapy and surgical procedures). More details provided in the clinical protocol.
* Patient has an Eastern Cooperative Oncology Group performance status 0 or 1.
* Patient has a left ventricular ejection fraction \> 45% as measured by resting echocardiogram, with no clinically significant pericardial effusion.
* Patient is fit for leukapheresis and has adequate venous access for the cell collection.
* Patient must have adequate organ function as indicated by the laboratory values in the clinical protocol
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
TCR2 Therapeutics
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Hassan R, Butler M, O'Cearbhaill RE, Oh DY, Johnson M, Zikaras K, Smalley M, Ross M, Tanyi JL, Ghafoor A, Shah NN, Saboury B, Cao L, Quintas-Cardama A, Hong D. Mesothelin-targeting T cell receptor fusion construct cell therapy in refractory solid tumors: phase 1/2 trial interim results. Nat Med. 2023 Aug;29(8):2099-2109. doi: 10.1038/s41591-023-02452-y. Epub 2023 Jul 27.
Other Identifiers
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TCR2-18-01
Identifier Type: -
Identifier Source: org_study_id
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