Clinical Trial to Test New Mesothelioma CAR T-Cell Immunotherapy
Research & Clinical Trials
Written by Travis Rodgers | Edited By Amy Edel
A new clinical trial launched this month is testing a novel immunotherapy that could offer hope to people with mesothelioma or other hard-to-treat cancers. It will explore an experimental treatment using CAR T-cells, a type of immune cell engineered to find and attack cancer cells. The 100-person National Cancer Institute study is now recruiting participants.
This trial is open to adults who have been diagnosed with mesothelioma or other solid tumors that have returned or spread after standard treatment. To qualify, more than 50% 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’s also found in high levels in people with ovarian cancer, pancreatic cancer, thymic cancer, bile duct cancers and non-small cell lung cancer.
Additional Key Eligibility Requirements
- No history of lung fibrosis, inflammatory lung disease or signs of pneumonitis at the start of enrollment
- No history of serious autoimmune or immune system diseases that aren’t controlled
- No other active cancers or uncontrolled illnesses
- Properly functioning organs
Dr. Raffit Hassan, an oncologist and senior investigator at the NCI, will lead the study. The trial for this treatment will take place at the NIH Clinical Center in Bethesda, Maryland. There is no cost to participate in the trial, and some costs may be covered.
What Kind of New Immunotherapy Is This Trial Testing?
This clinical trial will study 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 mesothelioma cells and kill them.
While CAR T-cell therapies have shown success in treating blood cancers, they have struggled to work against solid tumors like mesothelioma. This type of immunotherapy isn’t Food and Drug Administration- approved for mesothelioma yet and is only available in clinical trials.CAR T-cell therapy is approved for some blood cancers like leukemia and lymphoma.
Currently, there is no known cure for this aggressive cancer. But emerging new mesothelioma treatments are offering 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 type of mesothelioma affects the lining of the lungs, known as pleural mesothelioma. It can also affect the lining of the abdomen in peritoneal mesothelioma, the lining around the heart in pericardial mesothelioma and the tunica vagalis in testicular mesothelioma. Workplace exposure to asbestos is the most common cause of mesothelioma.
What Can I Expect if I Participate in This Trial?
In this early-phase clinical trial, first you’ll have a biopsy to measure your mesothelin levels. If your levels align with the study requirements, you’ll then begin the trial.
During treatment you’ll be hospitalized for at least 14 days. In the first 7 days, you’ll be given drugs in order to prepare for the study treatment. The modified T-cells will be reintroduced to you via IV. You’ll then spend an additional 7 days in the hospital, according to the study details.
Steps in the New TNhYP218 CAR T-Cell Trial
- You’ll have blood drawn through a vein.
- Your blood will then pass through a machine to separate the T-cells in a process called leukapheresis.
- Then your remaining blood will be reinfused back into your body through another vein.
- Your T-cells will be taken to a lab to be genetically modified, creating CARs known as TNhYP218 CAR T-cells, specifically designed to 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 5 years and could include imaging, blood and heart tests and a new biopsy, according to the trial description. Participants will be followed for safety for up to 15 years, per the FDA requirement.
The trial will begin with a phase I dose-escalation clinical trial. If successful, the trial will move to phase II, to a dose-expansion to determine the efficacy of the treatment, according to the study overview.
