Study on Using Genetically Modified T Cells to Treat Malignant Pleural Disease

Program Overview

The purpose of this study is to test the safety of using specially prepared T cells, taken from a patient's blood, to treat malignant pleural disease (MPD). These T cells are genetically modified to target a protein called mesothelin on cancer cells. In the first phase, researchers will determine a safe dose of these T cells. In the second phase, they will test this dose in combination with the drug pembrolizumab to see its effects on malignant pleural mesothelioma.

Description

This study involves two phases and is conducted at a single center. In Phase I, researchers will test different doses of T cells that are modified to target mesothelin, a protein found on certain cancer cells. These T cells will be given directly into the pleura, the area around the lungs, to patients with malignant pleural disease from mesothelioma, lung cancer, or breast cancer. The goal is to find a safe dose, with a maximum of 54 patients participating.

In Phase II, the study will focus on patients with mesothelioma, testing the safe dose found in Phase I along with pembrolizumab, a drug that helps the immune system fight cancer. Up to 21 patients may be involved in this phase.

Patients may receive radiation therapy to manage symptoms before or after the T cell treatment. If radiation is needed, it must be completed at least 2 days before starting another drug called cyclophosphamide.

For those in Phase II, pembrolizumab treatment will start about 4 weeks after the T cell therapy. Patients will receive three doses of pembrolizumab and be monitored for their response. If they benefit from the treatment without severe side effects, they may continue pembrolizumab for up to 6 months.

Patients who have previously participated and were removed from the study may re-enroll if they meet the criteria and could benefit from a higher dose. Outcomes for these patients will be analyzed separately.

Eligibility Criteria

Locations