A Phase I Study of Immunotherapy with Genetically Engineered T Cells (CAR T Cells) for Advanced Breast Cancer

Full Title

A Phase I Clinical Trial to Evaluate the Safety and Tolerability of Mesothelin-specific Chimeric Antigen Receptor (CAR)-positive T-Cells in Patients with Metastatic Mesothelin-expressing Breast Cancer

Purpose

A protein called mesothelin is overexpressed in some 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 metastatic HER2-negative breast cancer that has continued to grow despite 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.

Patients will receive the treatment 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 HER2-negative breast cancer that has continued to grow despite at least one prior regimen of therapy.
  • Patients must recover from the serious side effects of prior treatments before entering 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

16-040

Phase

I

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diseases