Full TitleA Single-Arm, Open-Label, Phase I Trial to Assess the Safety of Genetically Engineered Autologous T Cells Targeting the Cell Surface Antigen Mesothelin with Cell-Intrinsic Checkpoint Inhibition in Patients with Mesothelioma
Pleural mesothelioma is a cancer of the lining of the lungs. 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 mesothelioma that has the protein mesothelin and persists despite prior treatment.
The treatment involves removing some of 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. The CAR T cells also have an anti-PD1 component. PD1 is a protein that usually acts as a “brake” on the immune system. The anti-PD1 component releases the brakes and allows T cells to target and destroy cancer cells.
This treatment is given intrapleurally (directly into the chest cavity) via a catheter (a thin flexible tube) after the patient receives a chemotherapy drug called cyclophosphamide.
To be eligible for this study, patients must meet several criteria, including but not limited to the following:
- Patients must have pleural mesothelioma that persists despite prior treatment.
- Patients may not have previously received CAR T cells.
- Patients must have recovered from the serious side effects of prior therapies before entering the study.
- Patients must be able to walk and do routine activities for more than half of their normal waking hours.
- This study is for patients age 18 and older.