Chimeric Antigen Receptor (CAR) T-Cell Clinical Trial

In Clinical Studies News by Barbara Jacoby


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 study.

What is CAR T-Cell Therapy?

While new to mesothelioma treatment, 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 genetically altered so that they begin producing a 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.

The Current CAR Clinical Trial

CAR 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 different proteins on their cell surfaces.

The cell-based medicine company MaxCyte 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 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. MaxCyte is also using a new type of system for altering T-cells that is faster, allowing for quicker turnaround times in treating patients.

Qualifying 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, having other concurrent cancers or cancers in the past three years, and any current use of complementary or alternative therapies.

CAR 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 therapy for these cancers. Like the MaxCyte product already being tested in peritoneal patients, this one will target mesothelin proteins. A phase I trial is expected to begin soon and will be recruiting qualifying patients with pleural mesothelioma.

Potential Side Effects

Participating in a clinical trial is important for patients with difficult cancers like mesothelioma. It gives them a chance to access otherwise unavailable treatments that may work better than approved therapies and it allows them to help advance knowledge in treating that cancer. But on the other hand, there are risks. Clinical trials are conducted not just to measure effectiveness, but also adverse effects.

Some of the side effects patients being given CAR T-cell therapy can be troubling. The most common is a condition called CRS, cytokine release syndrome. Lasting no more than a week for most, CRS causes severe, flu-like symptoms: chills, fever, fatigue, achiness. This response is caused by the rapid response of the immune system.

Another potential side effect of CAR therapy is CAR T-cell-related encephalopathy syndrome. About five days after treatment is initiated, some patients experience confusion, disorientation, and an inability to talk. This can be disturbing and upsetting, but it resolves within a few days.

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 find out if you qualify and can help get you enrolled.