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

Sponsor: TCR2 Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05451849

Patient View

This Phase 1/2 trial evaluates TC-510, a cell therapy for mesothelin-expressing cancers. Eligible patients are adults with specific cancer types, confirmed MSLN expression, and prior systemic therapy. Interventions include TC-510, fludarabine, and cyclophosphamide. Participants must have adequate organ function and performance status, and be fit for leukapheresis.

Patient Parameters

Program Overview

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.

Eligibility 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

  • Inability to follow the procedures of the study
  • Known or suspected non-compliance, drug, or alcohol use

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