Phase 1 / 2 Trial of TC-210 T Cells in Patients With Advanced Mesothelin-Expressing Cancer

Status: Active

Description

TC-210 T cells are a novel cell therapy that consists of autologous genetically engineered T cells expressing 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. This Phase 1 / 2 study aims to establish the recommended Phase 2 dose (RP2D) and subsequently determine an overall response rate in patients with advanced mesothelin-expressing cancers.

Eligibility 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 Malignant Pleural/Peritoneal Mesothelioma (MPM), Serous Ovarian Adenocarcinoma, Cholangiocarcinoma, or Non-Small Cell Lung Cancer (NSCLC). - Patient's tumor has been pathologically reviewed by the central laboratory with confirmed positive MSLN expression on > 50% of tumor cells that are 2+ and/or 3+ by immunohistochemistry. - Prior to TC-210 T cell infusion, patients must have received at least 1 systemic standard of care therapy for metastatic or unresectable disease with more details provided in the clinical protocol - Patient has an Eastern Cooperative Oncology Group performance status 0 or 1. - Patient has a left ventricular ejection fraction > 45% as measured by resting echocardiogram, with no clinically significant pericardial effusion. - 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

Locations & Contacts

Texas

Houston
M D Anderson Cancer Center
Status: Active
Contact: David S. Hong
Phone: 713-792-4384

Trial Phase & Type

Trial Phase

Phase I/II

Trial Type

Treatment

Lead Organization

Lead Organization
TCR2 Therapeutics

Trial IDs

Primary ID TCR2-18-01
Secondary IDs NCI-2019-03186
Clinicaltrials.gov ID NCT03907852