A Phase I Study of Immunotherapy with Genetically Engineered T Cells (CAR T Cells) to Treat Mesothelioma and Malignant Pleural Disease from Lung and Breast Cancers

Full Title

A Phase I Clinical Trial of Malignant Pleural Disease Treated with Autologous T Cells Genetically Engineered to Target the Cancer-Cell Surface Antigen Mesothelin

Purpose

Patients with cancers of the pleura -- a lining of thin tissue that covers the lungs -- have a limited number of treatment options. Researchers have observed that the protein mesothelin is overexpressed in pleural disease from mesothelioma and lung or breast cancers. In this study, researchers are seeking to find the highest dose of genetically modified T cells (a type of white blood cell) that can be used to treat patients with pleural cancers that have continued to grow despite standard therapy.

The treatment involves utilizing a patient's own T cells and genetically modifying them in the laboratory to recognize mesothelin. The modified T cells, known as CAR T cells, are then returned to the patient to find and kill cancerous cells throughout the body. This approach is a form of immunotherapy.

All treatments in this study are given intrapleurally (directly into the chest cavity) via a catheter (a thin flexible tube).

Eligibility

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

  • Patients must have mesothelioma, or breast or non-small cell lung cancer that has spread to the pleura, and has continued to grow despite prior therapy.
  • Patients' tumors must contain the mesothelin protein.
  • At least 4 weeks must have passed since any major surgery or completion of prior chemotherapy or radiation therapy and entry into the study.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Prasad Adusumilli at 212-639-8093.

Protocol

15-007

Phase

I

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Locations