A Phase I/II Study of TC-210 Gene Therapy in People with Advanced Mesothelin-Expressing Cancers

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Full Title

A Phase 1/2 Single Arm Open-Label Clinical Trial Of TC-210 T Cells In Patients With Advanced Mesothelin-Expressing Cancer

Purpose

This purpose of this study is to find the highest dose of the investigational drug TC-210 that can be given safely in patients with metastatic lung cancer, mesothelioma, ovarian cancer, or cholangiocarcinoma (a bile duct cancer) that makes a protein called mesothelin. TC-210 targets and kills cancer cells that have mesothelin on their surfaces.

TC-210 is a form of gene therapy. It is made of T cells that are removed from a patient, genetically modified in the laboratory to enable them to attack and kill cancer cells, and then returned to that patient. Patients may also receive the chemotherapy drugs fludarabine and cyclophosphamide to prepare them to receive TC-210 treatment. All medications used in this study are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have metastatic lung cancer, mesothelioma, ovarian cancer, or cholangiocarcinoma that makes mesothelin and has continued to grow despite prior standard treatments.
  • Patients should recover from the serious side effects of previous therapies before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please call 212-639-5317.

Protocol

19-472

Phase

I/II

Disease Status

Relapsed or Refractory

Investigator