Kyverna Therapeutics
Kyverna Therapeutics works on 6 rare diseases tracked on Trial Friend, including Dermatomyositis, Lupus Nephritis, Multiple Sclerosis and 3 more, with 6 active clinical trials (3 recruiting).
Kyverna Therapeutics is an Emeryville, California cell therapy company chasing a first that would have sounded implausible a few years ago: an approved CAR-T therapy for a neurological autoimmune disease. Its lead therapy, miv-cel (KYV-101), engineers a patient's own T cells to deplete the CD19 B cells driving autoimmune attack, delivered as a one-time infusion with a design tuned for better tolerability in fragile neurology patients.
Stiff person syndrome is the beachhead. In December 2025 Kyverna announced positive topline data from KYSA-8, a registrational Phase 2 trial in 26 adults with the disease, and the full primary analysis presented at the American Academy of Neurology meeting in April 2026 showed statistically significant, durable benefit across all endpoints. The company is completing a rolling BLA submission in late 2026; if approved, miv-cel would become the first therapy ever specifically approved for stiff person syndrome.
Behind it, a Phase 3 trial in generalized myasthenia gravis is enrolling through 2027, backed by Phase 2 data showing deep responses sustained through 52 weeks, its multiple sclerosis program holds an FDA RMAT designation for non-active secondary progressive MS, and earlier work spans systemic sclerosis, myositis and lupus nephritis. For patients whose diseases are managed today with indefinite immunosuppression, Kyverna's one-time-reset premise is the thing to watch.
Kyverna Therapeutics Drug Pipeline
Kyverna Therapeutics has 6 active clinical trials across 4 development stages, with 3 currently recruiting participants. Clinical trials advance through phases: Phase 1 tests safety in a small group, Phase 2 evaluates effectiveness and side effects, Phase 3 confirms benefit in a larger population, and Phase 4 monitors long-term safety after FDA approval.
Note: This pipeline counts the active and recruiting trials listed on this page, from ClinicalTrials.gov. For companies that work outside rare disease, we list only trials for rare diseases we track, so the company's full pipeline may be larger.
Kyverna Therapeutics Clinical Trials (6)
Active and recruiting clinical trials sponsored by Kyverna Therapeutics, sourced live from ClinicalTrials.gov. Each trial card shows the study phase, current recruitment status, conditions under investigation, study locations, eligibility criteria, and a direct link to the full ClinicalTrials.gov record. You can also download a one-page PDF summary to share with your doctor.
Note: Recruitment statuses on ClinicalTrials.gov may not immediately reflect recent FDA decisions, sponsor announcements, or enrollment changes. Always confirm a trial's current status directly with the study coordinator.
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FDA-Approved Drugs
Kyverna Therapeutics Trial Locations
Kyverna Therapeutics clinical trials are running at 27 sites in 6 countries. Click any country to drill down by state, city, and individual research facility. Proximity to a trial site is one of the most important factors in deciding whether to participate.
Rare Disease Focus Areas (6)
Diseases targeted by Kyverna Therapeutics's clinical trial and drug development programs
Dermatomyositis is a rare autoimmune inflammatory disease causing muscle weakness and distinctive skin rashes, particularly over joints. It involves inflammation of muscles and skin blood vessels. Abo...
Lupus nephritis is kidney inflammation caused by systemic lupus erythematosus (SLE), in which the immune system attacks the kidneys' filters and, without treatment, can lead to kidney failure.
Multiple sclerosis is a chronic autoimmune disease where the immune system attacks the protective myelin sheath surrounding nerve fibers in the brain and spinal cord. This disrupts communication betwe...
Myasthenia gravis is a chronic autoimmune neuromuscular disorder causing muscle weakness and rapid fatigue. Antibodies attack acetylcholine receptors at the neuromuscular junction, preventing proper m...
Stiff Person Syndrome (SPS) is a rare neurological disorder characterized by progressive stiffness and rigidity of the trunk and limbs, along with painful muscle spasms. The condition results from aut...
Systemic sclerosis (scleroderma) is a rare autoimmune disease in which the immune system triggers scarring (fibrosis) of the skin and internal organs while also damaging small blood vessels. It can ha...
Patient Resources
Organizations and resources related to Kyverna Therapeutics's rare disease focus areas
Frequently Asked Questions About Kyverna Therapeutics
Common questions about Kyverna Therapeutics's rare disease programs, clinical trials, and treatments.