Thursday, June 30, 2022

Scientists Investigate Risk Cytokine Release Syndrome Associated With Using CAR-T Therapy


With more and more patients turning to CAR-T therapy to treat various syndromes and ailments around the world, doctors want to make sure that they can do a better job of predicting which individuals might wind up experiencing Cytokine Release Syndrome (CRS).

However, even though a number of organizations are studying CAR-T approaches to therapy, many of them are doing so with small clinical trials, which do not result in very much data to help determine what patients could be at more risk for CRS, according to a report from Fierce Biotech.

What Is CAR-T Therapy?

The term “CAR-T” refers to chimeric antigen receptor. Scientists use this innovative approach to boosting patients’ immune systems to campaign against certain types of cancers. It begins with a lab technician taking blood from a patient. Then, they take blood cells and use CAR-T therapy to train the immune system to recognize certain targeted antigen proteins.

These proteins identify rogue cancer cells, so the immune system can identify them readily and then destroy them before the patient gets sick or more sick. After the cells are enhanced in the lab setting, a technician infuses them back into the patient, where they start patrolling the blood system on alert for cancer cells with the specific antigen they’re set up to now recognize.

About Cytokine Release Syndrome Risk

CRS or cytokine release syndrome is a condition that can affect individuals as they receive CAR-T therapy.

As Fierce Biotech explained, CRS happens during CAR-T treatment “when a large, rapid release of immune system proteins called cytokines occurs in the blood. Symptoms include fever, nausea, headache, rash, rapid heartbeat, low blood pressure and trouble breathing.” While it is typically a mild response, sometimes the patient’s reaction could be quite severe and even life-threatening.

Hence the need to learn more about the connection between CAR-T therapeutic work and possible cytokine release syndrome. It’s crucial to find out more soon, as CRS has occurred during as many as 15 clinical trials since being tracked in 2016, per Fierce Biotech.

With that in mind, at the 2022 American Society of Clinical Oncology conference (ASCO), Medidata, a developer that creates clinical trial software, reported a study of data taken from 542 patients in various clinical trials using CAR-therapy, to help determine which of them might be more likely to have CRS.

What’s crucial is to gather as much information as possible about these patients and their clinical situations, to get more insight into the risk for CRS. While risk is difficult to quantify now, some new information could help. Medidata’s vice president, Jacob Aptekar said tests that are already commonly collected in labs today can help assess risk, such as the complete blood count test can help with CAR-T and CRS risk evaluations.

Aptekar also thinks that the Food and Drug Administration should set up a Risk Evaluation and Mitigation Strategy or REMS to require companies to make an in-depth plan about using medications and what the safety concerns are. That way, doctors can assess the potential benefits of using CAR-T therapies on patients with cancer in light of the possible risks of any of them experiencing cytokine release syndrome.

More Research Needed to Predict CRS Risk Associated With CAR-T Therapy

Ideally, there will be more tests of patients before they are deemed potential candidates for CAR-T therapy, with an awareness that they might experience CRS.

Knowing the relative risk for different patients based on measurements such as their complete blood count and comparing outcomes across thousands of other patients should make a big difference in determining the outcomes for more patients undergoing chimeric antigen receptor-based therapies.