Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer

Official Title

A Phase 1/2 Single Arm Open-Label Clinical Trial of Gavocabtagene Autoleucel (Gavo-cel) in Patients With Advanced Mesothelin-Expressing Cancer

Summary:

Gavocabtagene autoleucel (gavo-cel; TC-210) is 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.

Trial Description

Primary Outcome:

• Phase 1 - Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events.
• Phase 2 - To evaluate the efficacy of autologous genetically modified T cells (gavo-cel) in patients with MSLN-expressing unresectable, metastatic, or recurrent cancers as determined by overall response rate using RECIST v1.1

View this trial on ClinicalTrials.gov