On March 29,2024, Kyverna Th erapeutics announced a report in Med on the first use of KYV-101 (a full human anti-CD19 chimeric antigen receptor (CAR) T-cell candidate) in two patients with advanced multiple sclerosis (MS) in both patients without responding to the designated patient program.

The results showed that the safety of the treatment was acceptable, and no clinical symptoms of early neurotoxicity were observed, so that larger clinical studies in MS patients are necessary.

 KYV-101 is an autologous, whole-human CD19-targeted CAR T cell therapy for the treatment of B cell-driven autoimmune diseases. The CAR in KYV-101 was designed by the National Institutes of Health (NIH) to improve tolerability. The therapy was previously examined in a phase 1 trial of 20 patients with B cell lymphoma, and 55% of them achieved complete remission. Cytokine levels in the blood of patients receiving this therapy are low, and only 5% of patients develop severe nephrotoxicity.

In January, Kyverna Therapeutics announced that KYV-101 was granted fast-track status by the US FDA for the treatment of multiple sclerosis (MS). The IND application for the phase 2 clinical trial of KYV-101 in KYSA-7 for MS was approved by the FDA in early January.

Christoph Heesen, MD, professor of clinical and rehabilitative multiple sclerosis studies, at the University Medical Centre Ependorf, Hamburg, Germany, said: " We are very pleased to provide this therapeutic opportunity for patients who have exhausted other medical resources. New findings suggest that this approach may affect the disease biology of the CNS, which is promising, as preventing disease progression remains one of the most difficult challenges in MS treatment.”

"Explore the safety of CART administration in this population, and want to determine that it has an advantage compared with hematopoietic stem cell transplantation, can bring cell therapy to more patients in need," said Nicolaus Kroger, M. D. " if you can copy safe administration in other patients, and formally determine efficacy in clinical trials, this may bring treatment options for patients with multiple sclerosis.”