Chimeric Antigen Receptor (CAR) T-Cell Clinical Trial
Page Medically Reviewed and Edited by Kyle J. Becker, PharmD, MBA, BCOP This 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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The chimeric antigen receptor (CAR) T-cell clinical trials recruiting now represent a unique opportunity for patients who qualify to access an innovative medicine with great promise. This new type of immunotherapy modifies a patient’s immune system cells and has already shown good results with bone marrow and blood cancers. Trials are now recruiting peritoneal mesothelioma patients.
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 other cancer types, including leukemia in both children and adults.[1] It is also being tested in other cancers, including B-cell lymphoma, multiple myeloma, and acute myeloid leukemia.[2]
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Treatment with CAR T-cell therapy requires several steps:[1]
- It 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 to 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. Oncologists and researchers are now testing the therapy 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 it began testing for the treatment of ovarian cancer and peritoneal mesothelioma in 2018. The therapeutic candidate is known as MCY-M11.[3]
MCY-M11 is designed to target the cancer cell-expressed protein mesothelin, which is common in but not exclusive to mesotheliomas. A phase I trial ended and is no longer recruiting, but in 2020, MaxCyte announced the trial would continue.[4]
This is based on initial results that showed the feasibility of intraperitoneal delivery of the therapy. The results also showed the method was safe and that results for patients were promising and warranted further study.[5]
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 that they will be placed closer to the site of action.
MaxCyte is also using a new type of system for altering T-cells faster, allowing for quicker turnaround times in treating patients.
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.[6]
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.[7]
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.[2]
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 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.