In short
Currently, there is 1 ongoing clinical trial investigating lymphocyte adoptive therapy, specifically focusing on CAR-T cell therapy for blood-related cancers. This trial is examining how specially modified immune cells work in the body and how to better manage potential side effects affecting the nervous system.
Clinical trial locations
Study on Extracellular Vesicles in Hematology Patients Treated with Brexucabtagene Autoleucel and Drug Combination
This trial is designed to better understand how CAR-T cell therapy affects patients with blood cancers and to study a potential side effect that can affect the nervous system.
Who can participate:
- Adults over 18 years old
- Patients who need CAR-T treatment for their blood-related cancer
- Patients who are covered by a social security scheme or health insurance program
- Patients who understand the study and agree to participate by signing an informed consent form with the researcher
Main focus of the study:
The trial examines tiny particles called extracellular vesicles that cells release to communicate with each other. Researchers want to see how these particles change over time when patients receive CAR-T cell therapy. The study also focuses on a condition called Immune effector Cell-Associated Neurotoxicity Syndrome, or ICANS, which can temporarily affect the nervous system during treatment. Symptoms of ICANS may include confusion or difficulty speaking. The study will use imaging tests like MRI to observe any changes in the brain and monitor various immune system proteins called cytokines.
Treatment approach:
The trial uses several CAR-T cell therapy medications including Tecartus, Abecma, Kymriah, Breyanzi, and Yescarta. These are all forms of treatment that use a patient's own immune cells, which have been modified in a laboratory to better recognize and attack cancer cells. The modified cells are given back to the patient through an intravenous infusion. Gadovist, a contrast agent, will also be used during imaging tests to help doctors see internal body structures more clearly.
Study timeline:
After joining the study and completing initial health assessments, participants will receive their CAR-T cell therapy. They will then be monitored regularly to evaluate how the treatment affects their body, particularly looking at changes in extracellular vesicles and any signs of ICANS. Follow-up assessments may include cognitive tests and brain imaging. The study is expected to continue until November 2027.
Summary
This single ongoing trial in France represents an important effort to improve our understanding of CAR-T cell therapy for blood cancers. The study focuses particularly on managing neurological side effects that can occur during treatment. By examining how cells communicate through extracellular vesicles and monitoring for ICANS, researchers hope to develop better strategies for keeping patients safe during this innovative form of cancer treatment. The trial uses multiple approved CAR-T cell therapy products, reflecting the growing availability of these treatments for patients with blood-related cancers who need alternative therapeutic options.
