Kyverna Therapeutics plans to submit its CAR-T cell therapy for stiff person syndrome (SPS) to the FDA by mid-year after improved mobility outcomes and reduced disabilities in presented results. If approved, the company would aim for the first treatment for SPS and the first personalized CAR-T therapy for an autoimmune disease. The program uses engineered T cells designed to reset the immune system by depleting B cells, targeting an approach that is increasingly being tested in autoimmune indications. Kyverna’s goal places it at the center of a fast-growing CAR-T expansion beyond hematologic malignancies. For biotech stakeholders, the submission timing is a near-term regulatory milestone and could shape expectations for the broader autoimmune CAR-T category—particularly around endpoints, durability, and patient selection for a one-time cell therapy in non-oncology populations.