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

Trial Status: Active

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.

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

California

San Francisco
UCSF Medical Center-Mount Zion
Status: APPROVED
Contact: Helen Diller Family Comprehensive Cancer Center
Phone: 877-827-3222

New York

New York
Memorial Sloan Kettering Cancer Center
Status: ACTIVE
Contact: Roisin Eilish O'Cearbhaill
Phone: 646-888-4227

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: ACTIVE

Texas

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

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: IN_REVIEW

Trial Phase Phase I/II

Trial Type Treatment

Lead Organization
TCR2 Therapeutics

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