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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.
 
ClinicalTrials.gov Identifier: NCT03907852
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : May 27, 2022
Sponsor:
Collaborator:
Bristol-Myers Squibb
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 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.


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 High Grade Ovarian Serous Adenocarcinoma Biological: gavo-cel Drug: fludarabine Drug: cyclophosphamide Drug: Nivolumab Drug: Ipilimumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel 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 : July 2024
Estimated Study Completion Date : April 2026


Arm Intervention/treatment
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 gavo-cel
Biological: gavo-cel
gavo-cel

Drug: fludarabine
lymphodepletion chemotherapy

Drug: cyclophosphamide
lymphodepletion chemotherapy

Experimental: Lymphodepletion followed by gavo-cel plus nivolumab
fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel with nivolumab 360mg every 3 weeks starting on Day 21 post gavo-cel
Biological: gavo-cel
gavo-cel

Drug: fludarabine
lymphodepletion chemotherapy

Drug: cyclophosphamide
lymphodepletion chemotherapy

Drug: Nivolumab
immuno-oncology agent

Experimental: Lymphodepletion followed by gavo-cel plus nivolumab and ipilimumab
fludarabine 30 mg/m2/d on days -7 through -4 and cyclophosphamide 600 mg/m2/d on days -6 through -4 followed by gavo-cel with nivolumab 360mg every 3 weeks starting on Day 21 post gavo-cel and ipilimumab 1mg/kg every 6 weeks starting on Day 42 post gavo-cel
Biological: gavo-cel
gavo-cel

Drug: fludarabine
lymphodepletion chemotherapy

Drug: cyclophosphamide
lymphodepletion chemotherapy

Drug: Nivolumab
immuno-oncology agent

Drug: Ipilimumab
immuno-oncology agent




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

  2. Phase 2- Primary Objective [ Time Frame: ORR at 3 months; DCR based on ORR + SD lasting at least 8 weeks ]
    To evaluate the efficacy of autologous genetically modified T cells (gavo-cel), with or without immuno-oncology agents, in patients with MSLN-expressing unresectable, metastatic, or recurrent cancers as determined by overall response rate and disease control rate using RECIST v1.1 (or mesothelioma-specific RECIST criteria, if applicable).



Information from the National Library of Medicine

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

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 ClinicalTrials.gov identifier (NCT number): NCT03907852


Contacts
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Contact: Clinical 617-949-5200 gavo-cel@tcr2.com

Locations
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United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94143
Contact: Julie McCluggage       HDFCCC.CIP@ucsf.edu   
United States, Maryland
National Cancer Institute Recruiting
Bethesda, Maryland, United States, 20814
Contact    240-858-3159    Cathy.wagner@nih.gov   
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    cart@mskcc.org   
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Katie Elkins    215-615-6740    Katie.Elkins@pennmedicine.upenn.edu   
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact    615-329-7478    cann.researchreferrals@scresearch.net   
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact    713-792-4384    dke@mdanderson.org   
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2C1
Contact    416-946-4575      
Sponsors and Collaborators
TCR2 Therapeutics
Bristol-Myers Squibb
Investigators
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Study Chair: Clinical TCR2 Therapeutics
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Responsible Party: TCR2 Therapeutics
ClinicalTrials.gov Identifier: NCT03907852    
Other Study ID Numbers: TCR2-18-01
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: May 27, 2022
Last Verified: May 2022

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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
Mesothelioma, Malignant
Cholangiocarcinoma
Cystadenocarcinoma, Serous
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenoma
Neoplasms, Mesothelial
Pleural Neoplasms
Cystadenocarcinoma
Neoplasms, Cystic, Mucinous, and Serous
Cyclophosphamide
Nivolumab
Fludarabine
Ipilimumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs