Neurologists see CAR T-cell potential, but questions remain

Most neurologists believe that CAR T-cell treatments have the potential to revolutionize care for neuro-immune diseases such as myasthenia gravis (MG), but hopes are tempered by still-unanswered questions about their safety and long-term impact.

That’s according to a survey of 92 neurologists in the U.S. conducted last month by Spherix Global Insights.

“Neurologists clearly see a potential role for CAR T in neuro-immune disease, but the path to adoption will depend on much more than efficacy alone,” Georgiana Kuhlmann, senior insights director at Spherix Global Insights, said in a company press release. “The therapies that ultimately gain traction will need to demonstrate durable benefit while also addressing the practical realities of safety monitoring, referral, treatment-center access, and patient selection.”

MG is caused by self-reactive antibodies that block communication between nerve and muscle cells, resulting in MG symptoms such as muscle weakness and fatigue. The antibodies that drive MG are produced by immune cells called B-cells.

CAR T-cell therapy uses the body’s T-cells, which can kill other cells and coordinate immune responses, to target specific cells that cause disease, including cancer and autoimmune diseases such as MG. It involves equipping T-cells with a human-made molecular weapon, called a chimeric antigen receptor (CAR), that directs the T-cells to attack a target.

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Targeting B-cells

In MG, this experimental approach aims to target B-cells, the immune cells responsible for producing antibodies, including those that drive MG. Several CAR T-cell therapy candidates are being tested in MG clinical trials.

Across CAR T-cell investigational programs for neuroimmune conditions, Descartes-08, an experimental MG treatment from Cartesian Therapeutics that uses a CAR targeting the B-cell protein BCMA, emerged as the most recognized among surveyed neurologists.

KYV-101, a CAR T-cell therapy for MG from Kyverna Therapeutics that targets a different B-cell protein, CD19, ranked second in neurologist familiarity.

Both Descartes-08 and KYV-101 have shown promise for easing MG symptoms in clinical trials. About half of the neurologists reported “a highly favorable impression” of Descartes-08, and 37% said “they are extremely interested in having [KYV-101] approved and available,” Spherix said.

The survey suggests that neurologists are generally optimistic: 77% of respondents said they think CAR T-cell therapies could make current standards of care obsolete and redefine the management of MG and other antibody-driven diseases.

However, big questions remain unanswered, particularly concerning safety. This therapeutic approach was first developed to treat blood cancers, and while it has proven highly effective for eliminating target cells, it often carries serious safety risks.

In the survey, 74% of neurologists agreed that the safety profile of CAR T-cell therapies will be a major barrier to adoption. Neurologists also noted that there are still unknowns about the long-term effects of CAR T-cell therapies and how outcomes with CAR T-cells will compare with those of currently available MG treatments.

Beyond questions of safety and efficacy, logistics are a concern with CAR T-cell therapies. Administering these treatments is complex, and according to the Spherix survey, neurologists expect them to be administered primarily at specialty academic centers. Access to these centers and logistical support will therefore play a major role in the availability of CAR T-cell therapies for MG patients.

Overall, the survey indicates that the use of CAR T-cell therapies in MG will depend largely on “long-term safety, clear patient-selection criteria, streamlined referral and treatment pathways, and robust support for physicians and patients,” Spherix said.