A Phase 1 Study of Mesothelin-Targeted CAR T Cell Therapy in People With Esophagogastric Cancer

Full Title

A Phase I Trial of Intraperitoneal Mesothelin-Targeted CAR T-Cell Therapy in Patients with Mesothelin-Positive Esophagogastric Adenocarcinoma with Peritoneal Carcinomatosis

Purpose

Researchers want to find the best dose of a new CAR T cell therapy for esophagogastric cancer. Esophagogastric cancer is cancer of the esophagus or stomach. The people in this study have esophagogastric cancer that has metastasized (spread), including to the peritoneum (lining of the belly). In addition, their cancer makes a protein called mesothelin and keeps growing after initial treatment.

Mesothelin-targeted CAR T cell therapy is an immunotherapy made from your own white blood cells (called T cells). If you join this study, we will collect some of your T cells. We will add a gene (a small piece of DNA) from a virus. This will help your T cells find and kill cancer cells that have mesothelin. These genetically changed T cells are called chimeric antigen receptor (CAR) T cells. Treatments made from them are called CAR T cell therapies.

Before you get the study therapy, you will get chemotherapy to briefly weaken your immune system. These drugs will help prepare your body to receive the CAR T cell therapy. The treatments in this study are given intravenously (by vein).  

The CAR T cell therapy is given in the hospital. You must stay in the hospital for up to 7 days so we can monitor you for serious side effects. After you leave the hospital, you must stay within 1 hour of the hospital for the first full month. 

Who Can Join

To join this study, there are a few conditions. You must:

• Have metastatic esophagogastric cancer that keeps growing after treatment and makes mesothelin. You must have cancer that spread to the peritoneum, but cancer spread to additional sites is also permitted.
• Have recovered from the serious side effects of prior therapies before getting the study therapy.
• Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
• Be age 18 or older.

Contact

For more information or to see if you can join this study, please call Dr. Geoffrey Ku’s office at 646-608-2091.