A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- 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
EXCLUSION CRITERIA
Exclusion Criteria:
- Inability to follow the procedures of the study
- Known or suspected non-compliance, drug, or alcohol use
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
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
Age (in years)
18+
Phase
Phase 1/Phase 2
Participants needed
140
Est. Completion Date
Dec 31, 2027
Treatment type
Interventional
Sponsor
TCR2 Therapeutics
ClinicalTrials.gov identifier
NCT05451849
Study number
TCR2-21-01
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