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

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

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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