NCT03907852

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

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: TCR2 Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 evaluate the efficacy of gavo-cel, with and without immuno-oncology agents, in patients with advanced mesothelin-expressing cancers, with overall response rate and disease control rate as the primary Phase 2 endpoints.

Conditions

• Mesothelioma
• Mesothelioma, Malignant
• Mesothelioma; Pleura
• Mesotheliomas Pleural
• Mesothelioma Peritoneum
• Cholangiocarcinoma
• Cholangiocarcinoma Recurrent
• Ovarian Cancer
• Non Small Cell Lung Cancer
• Non Small Cell Lung Cancer Metastatic
• High Grade Ovarian Serous Adenocarcinoma

Interventions

Type	Name	Description
BIOLOGICAL	gavo-cel	gavo-cel
DRUG	fludarabine	lymphodepletion chemotherapy
DRUG	cyclophosphamide	lymphodepletion chemotherapy
DRUG	Nivolumab	immuno-oncology agent
DRUG	Ipilimumab	immuno-oncology agent

Timeline

• Start date: 2019-04-15
• Primary completion: 2024-11-19
• Completion: 2028-11-02
• First posted: 2019-04-09
• Last updated: 2025-08-27

Locations

11 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study