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Phase 1/2 Trial of TC-210 T Cells in Patients With Advanced Mesothelin-Expressing Cancer

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ClinicalTrials.gov Identifier: NCT03907852
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
TCR2 Therapeutics

Brief Summary:

TC-210 T cells are 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: TC-210 T Cells 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 TC-210 T Cells 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


Arm Intervention/treatment
Experimental: TC-210 T Cells
TC-210 T Cells
Drug: TC-210 T Cells
TC-210 T Cells

Experimental: Lymphodepletion followed by TC-210 T Cells
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: TC-210 T Cells
TC-210 T Cells

Drug: fludarabine
fludarabine

Drug: cyclophosphamide
cyclophosphamide

Experimental: Phase 2 Dose
MPM, cholangiocarcinoma, and ovarian cancer will receive TC-210 at the RP2D; NSCLC patients will receive TC-210 at the RP2D or TC-210 at the RP2D followed by anti-PD1
Drug: TC-210 T Cells
TC-210 T Cells

Drug: fludarabine
fludarabine

Drug: cyclophosphamide
cyclophosphamide

Biological: anti-PD1
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 TC-210 T cells 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 TC-210 T cell 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
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Contact: Clinical 617-949-5200 TC-210@tcr2.com

Locations
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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   
Sponsors and Collaborators
TCR2 Therapeutics
Investigators
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Study Chair: Clinical TCR2 Therapeutics

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Responsible Party: TCR2 Therapeutics
ClinicalTrials.gov Identifier: NCT03907852     History of Changes
Other Study ID Numbers: TCR2-18-01
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

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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
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 phosphate
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