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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03907852
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : June 29, 2021
Information provided by (Responsible Party):
TCR2 Therapeutics

Brief 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.

Condition or disease Intervention/treatment Phase
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 Drug: gavo-cel Drug: fludarabine Drug: cyclophosphamide Biological: anti-PD1 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Single Arm Open-Label Clinical Trial of Gavocabtagene Autoleucel (Gavo-cel) in Patients With Advanced Mesothelin-Expressing Cancer
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : January 2023

Arm Intervention/treatment
Experimental: gavo-cel
Drug: gavo-cel

Experimental: Lymphodepletion followed by gavo-cel
fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by TC-210 T Cells
Drug: gavo-cel

Drug: fludarabine

Drug: cyclophosphamide

Experimental: Phase 2 Dose
MPM, cholangiocarcinoma, and ovarian cancer will receive gavo-cel at the RP2D; NSCLC patients will receive gavo-cel at the RP2D or gavo-cel at the RP2D followed by anti-PD1
Drug: gavo-cel

Drug: fludarabine

Drug: cyclophosphamide

Biological: anti-PD1

Primary Outcome Measures :
  1. Phase 1 - Establish the recommended Phase 2 dose (RP2D) according to dose-limiting toxicity (DLT) of defined adverse events. [ Time Frame: DLTs within 28 days post-treatment ]
  2. 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 [ Time Frame: Overall Response Rate at 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
  • 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 gavo-cel 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03907852

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Contact: Clinical 617-949-5668

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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Julie McCluggage   
United States, Maryland
National Cancer Institute Recruiting
Bethesda, Maryland, United States, 20814
Contact    240-858-3159   
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Roisin O'Cearbhail, MD    646-608-3742   
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Katie Elkins    215-615-6740   
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact    615-329-7478   
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact    713-792-4384   
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2C1
Contact    416-946-4575      
Sponsors and Collaborators
TCR2 Therapeutics
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Study Chair: Clinical TCR2 Therapeutics
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Responsible Party: TCR2 Therapeutics Identifier: NCT03907852    
Other Study ID Numbers: TCR2-18-01
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Mesothelioma, Malignant
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Pleural Neoplasms
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents