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

ClinicalTrials.gov Identifier

NCT03907852

Institution Name

National Cancer Institute

Full Institution Address

9000 Rockville Pike Bethesda Maryland 20892 United States

Institution Phone

(240) 858-3159

Institution Website

https://clinicaltrials.gov/ct2/show/NCT03907852

Principal Investigator

Raffit Hassan

Principal Investigator Phone

(240) 858-3159

Principal Investigator Email

Cathy.wagner@nih.gov

Study Coordinator

Cathy Wagner

Study Coordinator Phone

(240) 858-3159

Study Coordinator Email

Cathy.wagner@nih.gov

Additional Study Coordinators

Donna Mabry 240-858-3155 donna.mabry@nih.gov

Study Overview

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.

Enrollment Information

Open

Study Start Date

20190409

Study End Date

20260401

Study Purpose

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. 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

Patient is > 18 years of age at the time the Informed Consent is signed. Patient has a pathologically confirmed diagnosis of Cholangiocarcinoma. 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

Exclusion Criteria

Tumor has to be tested by NCI central laboratory and have confirmed MSLN expression on more than 50% of tumor cells

Financial Assistance Available

Yes

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