A new clinical trial that launched this month is testing a new immunotherapy regimen that could offer hope to people with mesothelioma and other hard to treat cancers. It will be examining an experimental treatment that utilizes CAR-T cells, an immune cell engineered to find and attack cancer cells. The 100-person National Cancer Institute study is now recruiting participants. The study is available to adults who have been diagnosed with mesothelioma or other solid tumors that have returned or spread after treatment. For patients to qualify for the study, more than 50 percent of tumor cells must test positive for a specific protein called mesothelin. This protein is often found in high levels in people with pleural and peritoneal mesothelioma. It can also be found in high levels in people with ovarian cancer, pancreatic cancer, thymic cancer, bile duct cancers, and non-small cell lung cancer.
There are different eligibility requirements patients must meet to qualify for the study. This includes no history of lung fibrosis, inflammatory lung disease, or signs of pneumonitis at the start of enrollment. It is also required to have no history of serious autoimmune or immune system diseases that are not controlled. To be eligible, patients must have no other active cancers or uncontrolled illnesses and should have properly functioning organs. The trial will take place at the NIH Clinical Center in Bethesda, Maryland. There are no costs to participate in the study and some costs may be covered.
The study will be looking at the effects of a therapy called TNhYP218 CAR T-cells, which target the protein mesothelin. CAR T-cell therapy takes T cells, a type of white blood cell, and changes them in a lab so they make chimeric antigen receptors. This special receptor, or CAR, helps T cells recognize and kill mesothelioma cells. CAR T-cells have shown to be successful when treating blood cancers but have struggled to work against solid tumors like mesothelioma. This type of immunotherapy is not yet approved by the Food and Drug Administration for mesothelioma. It is only available in clinical trials. CAR T-cell therapy is approved for some blood cancers like leukemia and lymphoma. There is no cure for mesothelioma, but emerging new treatments for mesothelioma are giving hope for longer survival and better quality of life. Advances to standard treatments are also improving how doctors are able to manage the disease. The most common form of mesothelioma is pleural mesothelioma, which affects the lining of the lungs. It can also affect the lining of the abdomen, which is known as peritoneal mesothelioma. It can also affect the lining of the heart, known as pericardial mesothelioma and the tunica vaginalis, known as testicular mesothelioma. Workplace exposure to asbestos is the most common cause of mesothelioma.
In this early phase clinical trial, a biopsy will be performed to measure mesothelin levels. If your levels align with the study requirements, you will begin the trial. During treatment, you will be hospitalized for at least 14 days. In the first seven days, you will be given drugs to prepare you for the study treatment. The engineered T-cells will be reintroduced to you via IV. You will then stay an additional seven days in the hospital.
Steps in TNhYP218 trial:
- Blood will be drawn through a vein
- Blood will pass through a machine that separates the T-cells in a process called leukapheresis
- Remaining blood will be infused back into the body through another vein
- T-cells will be taken to a lab to be genetically modified, creating CARS known as TNhYP218 CAR T-cells, which are created to specifically target mesothelin
- Follow up visits will be scheduled to monitor the results of the therapy and your overall health
Follow up visits will be conducted for five years and can include imaging, blood and heart tests and a new biopsy. Participants will be followed for safety for up to 15 years, per the FDA requirement.
The trial will start as a phase I dose escalation clinical trial. If successful, the trial will move to phase II, to a dose expansion study to determine the efficacy of the treatment.
