NCT03907852Active, not recruitingPhase 1/2
Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer
A Phase 1/2 Single Arm Open-Label Clinical Trial of Gavocabtagene Autoleucel (Gavo-cel) in Patients With Advanced Mesothelin-Expressing Cancer
Source: ClinicalTrials.gov · Last updated 27 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 57 (actual)
- First submitted
- 1 Apr 2019
- Start date
- 15 Apr 2019
- Primary completion date
- 19 Nov 2024
- Lead sponsor
- TCR2 Therapeutics
- NCT number
- NCT03907852
What you commit to
- Study type: Interventional · Phase 1/2
- Participants enrolled: 57
- From 15 Apr 2019 to the primary completion date, 19 Nov 2024
- 11 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Patient is at least 18 years of age at the time the Informed Consent is signed.
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Princess Margaret Cancer Centre Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| National Cancer Institute Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| University of Chicago Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| University of Texas - MD Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| University of Miami - Sylvester Cancer Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| SCRI Oncology Partners Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.