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

NCT03907852

Description:

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.

Related Conditions:
  • Cholangiocarcinoma
  • Malignant Pleural Mesothelioma
  • Non-Small Cell Lung Carcinoma
  • Ovarian Serous Adenocarcinoma
  • Peritoneal Mesothelioma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Phase 1/2 Trial of TC-210 T Cells in Patients With Advanced Mesothelin-Expressing Cancer
  • Official Title: A Phase 1/2 Single Arm Open-Label Clinical Trial of TC-210 T Cells in Patients With Advanced Mesothelin-Expressing Cancer

Clinical Trial IDs

  • ORG STUDY ID: TCR2-18-01
  • NCT ID: NCT03907852

Conditions

  • 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

Interventions

DrugSynonymsArms
TC-210 T CellsTC-210 T Cells
fludarabineLymphodepletion followed by TC-210 T Cells
cyclophosphamideLymphodepletion followed by TC-210 T Cells
anti-PD1Phase 2 Dose

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
TC-210 T CellsExperimentalTC-210 T Cells
  • TC-210 T Cells
Lymphodepletion followed by TC-210 T CellsExperimentalfludarabine 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
  • TC-210 T Cells
  • fludarabine
  • cyclophosphamide
Phase 2 DoseExperimentalMPM, 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
  • TC-210 T Cells
  • fludarabine
  • cyclophosphamide
  • anti-PD1

Eligibility 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:TCR2 Therapeutics

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