A Phase 1/2 Trial of TC-510 In Patients With Advanced Mesothelin-Expressing Cancer

• Status: Recruiting
• Trial end date: 2027-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: TCR2 Therapeutics
• Treatments: Cyclophosphamide; Fludarabine

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.

• 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:

• Inability to follow the procedures of the study

• Known or suspected non-compliance, drug, or alcohol use