Phase 1/2 Trial of Gavo-cel (TC-210) in Patients With Advanced Mesothelin-Expressing Cancer
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| ClinicalTrials.gov Identifier: NCT03907852 |
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Recruitment Status :
Recruiting
First Posted : April 9, 2019
Last Update Posted : December 17, 2020
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Sponsor:
TCR2 Therapeutics
Information provided by (Responsible Party):
TCR2 Therapeutics
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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 |
| 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 : | June 2021 |
| Estimated Study Completion Date : | January 2023 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: gavo-cel
gavo-cel
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Drug: gavo-cel
gavo-cel |
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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
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Drug: gavo-cel
gavo-cel Drug: fludarabine fludarabine Drug: cyclophosphamide cyclophosphamide |
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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
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Drug: gavo-cel
gavo-cel Drug: fludarabine fludarabine Drug: cyclophosphamide cyclophosphamide Biological: anti-PD1 anti-PD1 |
Primary Outcome Measures :
- 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 ]
- 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 ]
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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).
- 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 ClinicalTrials.gov identifier (NCT number): NCT03907852
Contacts
| Contact: Clinical | 617-949-5668 | TC-210@tcr2.com |
Locations
| 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
Investigators
| Study Chair: | Clinical | TCR2 Therapeutics |
| 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: | December 17, 2020 |
| Last Verified: | December 2020 |
| 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 Cholangiocarcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
Neoplasms, Mesothelial Adenocarcinoma Carcinoma Cyclophosphamide Fludarabine Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists |