Chimeric Antigen Receptor (CAR) T-Cell Clinical Trial
Page Medically Reviewed and Edited by Kyle J. Becker, PharmD, MBA, BCOPThis page has been fact checked by a Doctor of Pharmacy who specializes in Oncology. Sources of information are listed at the bottom of the article.
We make every attempt to keep our information accurate and up-to-date.
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An exciting new immunotherapy treatment is now being tested in a phase I clinical trial that is still recruiting for participants. This provides a unique opportunity for patients who qualify to get access to an innovative medicine with great promise. Known as CAR T-cell therapy, this new treatment uses gene therapy to modify a patient’s immune system cells.
Previously this type of therapy showed successful results with patients suffering from bone marrow and blood cancers. The current trial is recruiting patients with peritoneal mesothelioma and ovarian cancer. If you have been diagnosed with peritoneal mesothelioma, and are interested in participating in clinical trials, talk to your medical team to find out if you qualify for the CAR T-cell study.
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What is CAR T-Cell Therapy?
While new to mesothelioma treatment, chimeric antigen receptor (CAR) T-cell therapy is not entirely new. It has been used and is already approved for some other types of cancer, including leukemia in both children and adults. It is also being tested in other cancers, including B-cell lymphoma, multiple myeloma, and acute myeloid leukemia.
Treatment with CAR T-cell therapy begins with taking a patient’s blood and isolating T-cells. These are the cells in the immune system that are mostly responsible for attacking and killing unhealthy cells and pathogens in the body. The T-cells are then modified outside the body so that they begin producing a cancer-specific receptor molecule on their cell surfaces. This receptor is the CAR, or chimeric antigen receptor.
The CAR has been created synthetically and is designed to target and attach to proteins on the surfaces of cancer cells. Once the T-cells have been modified with CAR they are injected back into the patient’s bloodstream. They multiply and the CAR molecules on all these T-cells quickly go to work attaching to and killing cancer cells.
CAR T-Cell Therapy for Peritoneal Mesothelioma
CAR T-cell therapy has been important in treating childhood leukemia in particular. It is now being expanded and tested with other types of cancers. Researchers often need to develop a new type of antigen because different cancers produce unique proteins on their cell surfaces.
MaxCyte, a cell-based medicine company, has produced a CAR T-cell therapy that is now being tested for ovarian cancer and peritoneal mesothelioma. The therapeutic candidate is known as MCY-M11, and it is currently being tested in the phase I clinical trial in the U.S. There are two locations: the National Institutes of Health in Maryland and Washington University in St. Louis. MCY-M11 is designed to target the cancer cell-expressed protein mesothelin, which is common in but not exclusive to mesotheliomas.
What makes MCY-M11 different from previous trials with CAR T-cell therapies is that the altered T-cells will not be given intravenously. Patients with peritoneal mesothelioma will have their T-cells injected directly into the abdominal cavity, so they will be placed closer to the site of action. MaxCyte is also using a new type of system for altering T-cells that is faster, allowing for quicker turnaround times in treating patients.
The MaxCyte CAR T-cell therapy clinical trial is currently recruiting patients. To qualify, peritoneal mesothelioma patients must have a longer than three month life expectancy and be four weeks or more past their last treatment. They must not be eligible for surgical treatment.
Disqualifying factors for the study include pregnancy, HIV, or hepatitis B or C, metastasis to the brain, serious heart disease, autoimmune disease, having other concurrent cancers or cancers in the past three years, and any current use of complementary or alternative therapies.
CAR T-Cell Therapy for Pleural Mesothelioma
Studies are also just beginning that will use CAR T-cell therapy for pleural mesothelioma and lung cancer. The Abramson Cancer Center in Philadelphia recently received a large grant from the National Cancer Institute to develop a CAR T-cell therapy for these cancers. Like the MaxCyte product already being tested in peritoneal patients, this one will target mesothelin proteins. This phase I trial is recruiting qualifying patients with pleural mesothelioma.
Further, results from another phase I trial were reported showing both safety and efficacy with a mesothelin-targeting CAR T-cell therapy. Researchers observed no CAR T-cell-related safety events, while witnessing promising improvement in the disease. Phase I trial results can be difficult to interpret, but of the nineteen pleural mesothelioma patients, two had complete metabolic response, with five partial responses and another four patients with stable disease.
Potential Side Effects
Participating in a clinical trial is important for patients with challenging cancers like mesothelioma. It gives patients a chance to access otherwise unavailable treatments that may work better than currently-approved therapies, and it allows them to help advance knowledge in treating that disease. On the other hand, there are risks. Clinical trials are conducted not only to measure effectiveness, but adverse effects as well.
Some of the side effects of CAR T-cell therapy can be troubling. The most common side effect is a condition called cytokine release syndrome (CRS). CRS causes severe, flu-like symptoms: chills, fever, fatigue, aches, generally lasting between three and twenty-one days. This response is caused by the rapid response of the immune system. In worst cases, multiple-organ failure can occur, so this is a medical emergency.
Another potential side effect of CAR T-cell therapy is CAR T-cell-related encephalopathy syndrome, also known as immune effector cell-associated neurotoxicity syndrome (ICANS). About five days after treatment is initiated, some patients experience confusion, disorientation, and an inability to talk. This is also a medical emergency and should be reported to your provider.
CAR T-cell therapy holds a huge amount of promise for patients with all types of cancer. It is already helping children with leukemia and is now being tested on rarer but difficult cancers like mesothelioma. If you are interested in being a part of this study, your doctors can determine if you qualify and can help get you enrolled.
Page Medically Reviewed and Edited by Kyle J. Becker, PharmD, MBA, BCOP
Kyle J. Becker, PharmD is certified by the Board of Pharmacy Specialties in Oncology Pharmacy. Dr. Becker earned his pharmacy degree from Shenandoah University and he currently serves as an oncology pharmacist at Parkview Cancer Institute.