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Clinical Trials in the USA / NCT03907852
Active, not recruiting Phase 1/2

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

NCT03907852 · tracked via the Priya Life Science USA tracker
Sponsor
TCR2 Therapeutics
Phase
Phase 1/2
Started
2019-04-15
Last updated
2025-08-27

Condition(s) studied

MesotheliomaMesothelioma, MalignantMesothelioma; PleuraMesotheliomas PleuralMesothelioma PeritoneumCholangiocarcinomaCholangiocarcinoma RecurrentOvarian CancerNon Small Cell Lung CancerNon Small Cell Lung Cancer MetastaticHigh Grade Ovarian Serous Adenocarcinoma

Investigational drug(s) / intervention(s)

gavo-celfludarabinecyclophosphamideNivolumabIpilimumab

gavo-cel: gavo-cel

fludarabine: lymphodepletion chemotherapy

cyclophosphamide: lymphodepletion chemotherapy

Nivolumab: immuno-oncology agent

Ipilimumab: immuno-oncology agent

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * Patient is at least 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) at screening. * Patient's tumor has been pathologically reviewed by the central laboratory. For Serous Ovarian Adenocarcinoma, patients must have confirmed positive MSLN expression on \>/= 30% of tumor cells that are 1+, 2+, and/or 3+ by immunohistochemistry (IHC). Ovarian patients will subsequently be stratified into two groups: high MSLN expression (\>/= 50% of tumor cells that are 2+ and/or 3+) or low MSLN expression (\>/= 30% of tumor cells that are 1+, 2+, and/or 3+ not meeting criteria for the high MSLN expression group). MPM patients must have MSLN expression of \>/= 50% of tumor cells that are 2+ and/or 3+ by IHC. Cholangiocarcinoma and NSCLC patients must have MSLN expression of \>/= 30% of tumor cells that are 1+, 2+, and/or 3+ by IHC. * Prior to gavo-cel infusion, patients must have received at least 1 systemic standard of care therapy for metastatic or unresectable disease, with the exception of Cholangiocarcinoma patients who may have elected not to pursue standard frontline therapy. Regardless of tumor type, patients must not exceed 5 prior lines of therapy (excluding bridging therapy and surgical procedures). 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

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
University of California, San Francisco San Francisco California
University of Miami Sylvester Cancer Center Miami Florida
University of Chicago Medical Center Chicago Illinois
National Cancer Institute Bethesda Maryland
Columbia University Medical Center New York New York
Memorial Sloan Kettering Cancer Center New York New York
Duke University Durham North Carolina
University of Pennsylvania Philadelphia Pennsylvania
SCRI Oncology Partners Nashville Tennessee
University of Texas MD Anderson Cancer Center Houston Texas
Princess Margaret Cancer Centre Toronto Ontario

On this site

📄 Opdivo (nivolumab) drug profile →

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03907852 on ClinicalTrials.gov ↗ ← All trials in the USA