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 : March 16, 2023
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Sponsor:
TCR2 Therapeutics
Collaborator:
Bristol-Myers Squibb
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 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 |
| 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 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Cholangiocarcinoma
| Arm | Intervention/treatment |
|---|---|
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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 gavo-cel
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Biological: gavo-cel
gavo-cel Drug: fludarabine lymphodepletion chemotherapy Drug: cyclophosphamide lymphodepletion chemotherapy |
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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
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Biological: gavo-cel
gavo-cel Drug: fludarabine lymphodepletion chemotherapy Drug: cyclophosphamide lymphodepletion chemotherapy Drug: Nivolumab immuno-oncology agent |
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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
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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 :
- 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.
- 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).
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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 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
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 | 617-949-5200 | gavo-cel@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, Florida | |
| University of Miami Sylvester Cancer Center | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Sim Chehal 305-243-1696 sxc2314@med.miami.edu | |
| United States, Illinois | |
| University of Chicago Medical Center | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Brooke Pieke, MS 773-834-9636 bpieke@bsd.uchicago.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 | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Camden Esancy 212-342-3884 ce2331@cumc.columbia.edu | |
| 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
| 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: | March 16, 2023 |
| Last Verified: | March 2023 |
| 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 |