Ovarian Cancer Clinical Trial

Phase 1/2 Trial of Gavo-cel (TC-210) 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 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.

View Eligibility Criteria

Eligibility 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) at screening.
Patient's tumor has been pathologically reviewed by the central laboratory. For MPM and Serous Ovarian Adenocarcinoma indications, patients must have confirmed positive MSLN expression on >/= 50% of tumor cells that are 2+ and/or 3+ by immunohistochemistry. Cholangiocarcinoma and NSCLC patients must have a MSLN expression on >/= 50% of tumor cells that are 1+, 2+, and/or 3+ by immunohistochemistry.
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

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

175

Study ID:

NCT03907852

Recruitment Status:

Recruiting

Sponsor:

TCR2 Therapeutics

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 7 Locations for this study

See Locations Near You

University of California, San Francisco
San Francisco California, 94143, United States More Info
Julie McCluggage
Contact
[email protected]
National Cancer Institute
Bethesda Maryland, 20814, United States More Info
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Roisin O'Cearbhail, MD
Contact
646-608-3742
[email protected]
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States More Info
Katie Elkins
Contact
215-615-6740
[email protected]
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States More Info
University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States More Info
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada More Info
Contact
416-946-4575

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Phase:

Phase 1

Estimated Enrollment:

175

Study ID:

NCT03907852

Recruitment Status:

Recruiting

Sponsor:


TCR2 Therapeutics

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.