A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
Stopped early · Phase 1/Phase 2
Conditions studied: Mesothelioma, Mesotheliomas Pleural, Mesothelioma, Malignant, Mesothelioma Peritoneum, Ovarian Cancer, Ovarian Serous Adenocarcinoma, Pancreatic Cancer, Pancreatic Adenocarcinoma, Colorectal Cancer, Triple Negative Breast Cancer, TNBC - Triple-Negative Breast Cancer, Ovarian Adenocarcinoma, Pancreatic Neoplasms, Colorectal Neoplasms, Ovarian Neoplasms, Cholangiocarcinoma, Non Small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT05451849
- Run by
- TCR2 Therapeutics
- People needed
- 14
- Starts
- 2022-06-21
- Expected to finish
- 2025-08-30
- Last updated by the study team
- 2026-07-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Inability to follow the procedures of the study
- Known or suspected non-compliance, drug, or alcohol use
Where it is running
- University of California, San Francisco — San Franciso, California, United States
- University of Miami — Miami, Florida, United States
- National Cancer Institute — Bethesda, Maryland, United States
- University of Minnesota, Masonic Cancer Center — Minneapolis, Minnesota, United States
- Montefiore Einstein Cancer Center — The Bronx, New York, United States
- University of Oklahoma — Oklahoma City, Oklahoma, United States
- SCRI Oncology Partners — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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