NCT05451849TerminatedPhase 1/2
A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
A Phase 1/2 Single Arm Open-Label Clinical Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Reason given: No participants were enrolled in Phase 2 as Phase I was terminated early due to the lack of a clear signal of robust clinical activity.
Brief summary (registry, in English)
TC-510 is a novel cell therapy that consists of autologous genetically engineered T cells expressing two synthetic constructs: first, 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 and second, a PD-1:CD28 switch receptor, which is expressed on the surface of the T cell, independently from the TCR. The PD-1:CD28 switch receptor comprises the PD-1 extracellular domain fused to the CD28 intracellular domain via a transmembrane domain. Thus, the switch is designed to produce a costimulatory signal upon engagement with PD-L1 on cancer cells.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 14 (actual)
- First submitted
- 21 Jun 2022
- Start date
- 21 Jun 2022
- Primary completion date
- 30 Aug 2025
- Lead sponsor
- TCR2 Therapeutics
- Diseases
- Mesothelioma, Ovarian cancer, Pancreatic cancer, Colorectal cancer, Triple-negative breast cancer, Liver and biliary tract cancer, Lung cancer
- NCT number
- NCT05451849
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Known or suspected non-compliance, drug, or alcohol use
Other
- Inability to follow the procedures of the study
Who the study is looking for
- Patient is > 18 years of age at the time the Informed Consent is signed.
- Patient has a pathologically confirmed diagnosis of either MPM, Serous Ovarian Adenocarcinoma, Pancreatic Adenocarcinoma, TNBC, and Colorectal Cancer
- Patient's tumor has been reviewed with confirmed positive MSLN expression on >/= 50% of tumor cells that are 1+, 2+ and/or 3+ by immunohistochemistry. Patients with epithelioid MPM, confirmation of MSLN expression is not required prior to enrollment.
- Prior to TC-510 infusion, patients must have received at least 1 but no more than 5 systemic therapies for metastatic or unresectable disease with more details provided in the protocol
- Patients has an ECOG performance status 0 or 1
- 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 (7)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Institute | Bethesda | United States | Unknown status |
| University of Miami | Miami | United States | Unknown status |
| University of Minnesota/Masonic Cancer Center | Minneapolis | United States | Unknown status |
| SCRI Oncology Partners | Nashville | United States | Unknown status |
| University of Oklahoma | Oklahoma City | United States | Unknown status |
| University of California, San Francisco | San Franciso | United States | Unknown status |
| Montefiore Einstein Cancer Center | The Bronx | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.