Kyv-101 Medicine 04 December 2025 Extended indication Kyv-101 in combination with standard lymphodepletion regimen for second line or later treatment of refractory Stiff person syndrome in adults and elderly with inadequate response to at least one immunomodulatory therapy. Therapeutic value No estimate possible yet Total cost Registration phase Clinical trials Product Active substance Kyv-101 Domain Neurological disorders Reason of inclusion New medicine (specialité) Main indication Muscular diseases other Extended indication Kyv-101 in combination with standard lymphodepletion regimen for second line or later treatment of refractory Stiff person syndrome in adults and elderly with inadequate response to at least one immunomodulatory therapy. Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Kyverna Portfolio holder Kyverna Mechanism of action CAR-T therapy Route of administration Intravenous Therapeutical formulation Intravenous drip Budgetting framework Intermural (MSZ) Centre of expertise Additional remarks CAR T-cell therapy involves modifying a patient’s T cells to recognise and remove B cells in the patient’s body. KYV-101, specifically targets CD19, a protein expressed on the surface of B cells, which is involved in various types of autoimmune diseases. Registration Registration route Centralised (EMA) Type of trajectory Normal trajectory Particularity ATMP Yes Submission date June 2026 Expected Registration July 2027 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options De symptomen kunnen met behandeling worden beheerd. De behandeling richt zich op het verminderen van spierstijfheid en pijnlijke spasmen. Bijvoorbeeld door middel van spierverslappers en IVIg. Therapeutic value No estimate possible yet This assessment does not indicate any potential inclusion in the package. Substantiation Er is een open label studie gestart. Er zijn nog onvoldoende resultaten beschikbaar om een inschatting te maken over de therapeutische waarde. Duration of treatment Frequency of administration Dosage per administration References NCT06588491 (KYSA-8) Additional remarks Expected patient volume per year Patient volume < 5 Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Erasmus MC (1); Expertopinie (2) Additional remarks In Nederland wordt het aantal patiënten met Stiff Person Syndrome (SPS) geschat op circa 50 (1). De precieze plaats van deze behandeling is nog niet duidelijk. Waarschijnlijk zal het gaan om een aanvullende optie voor patiënten die onvoldoende reageren op bestaande therapieën. Daarmee komt het in de praktijk neer op hooguit enkele behandelingen per jaar (2). Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Indications off label use References Additional remarks Indication extension Indication extensions Indication extensions References Additional remarks Other information Additional remarks