Kyverna Therapeutics to Report Phase 2 Trial Results for CAR T-Cell Therapy in Stiff Person Syndrome
Key Insights
Kyverna Therapeutics will announce topline results from its registrational Phase 2 KYSA-8 trial evaluating KYV-101 in stiff person syndrome (search) on December 15, 2025.
KYV-101 is a fully human, autologous CD19 (search) CAR T-cell therapy designed to achieve deep B-cell depletion and immune system reset with a single administration.
The company is advancing KYV-101 through late-stage clinical development with registrational trials for both stiff person syndrome (search) and myasthenia gravis (search).
Kyverna Therapeutics announced it will host a live webcast and conference call on Monday, December 15, 2025 at 8:00 am ET to review topline results from the registrational Phase 2 KYSA-8 clinical trial evaluating KYV-101 in stiff person syndrome (search) (SPS). The clinical-stage biopharmaceutical company is focused on developing cell therapies for patients with autoimmune diseases (search).
Novel CAR T-Cell Approach for Autoimmune Disease
KYV-101 represents a fully human, autologous, CD19 (search) CAR T-cell therapy with CD28 (search) co-stimulation, designed for potency and tolerability. The therapy is under investigation for B-cell-driven autoimmune diseases (search) and aims to achieve deep B-cell depletion and immune system reset with a single administration. According to the company, KYV-101 has potential to deliver durable drug-free, disease-free remission in autoimmune diseases.
Expanding Clinical Development Program
Kyverna's lead CAR T-cell therapy candidate is advancing through late-stage clinical development with registrational trials for both stiff person syndrome (search) and myasthenia gravis (search). The company is also conducting two ongoing multi-center Phase 1/2 trials for patients with lupus nephritis (search). Additional KYSA trials and investigator-initiated trials are underway in multiple sclerosis (search) and rheumatoid arthritis (search) to inform the next priority indications for late-stage development.
Next-Generation Pipeline Development
The company's pipeline includes next-generation CAR T-cell therapies in both autologous and allogeneic formats, with plans to expand into broader autoimmune indications. Kyverna is developing KYV-102 using its proprietary whole blood rapid manufacturing process, which has the potential to increase patient reach.
Conference Call Access
Participants will need to register at the provided URL to listen and participate in the call. Once registered, participants will receive a dial-in phone number and unique PIN number required to join the call. The call can also be accessed via live webcast, with the webcast and supporting presentation materials available on the "Events & Presentations" section of Kyverna's Investor Relations webpage. An archived replay will be available on the website following the live event.