mivocabtagene autoleucel

Mivocabtagene autoleucel is a fully human, autologous CD19-targeted chimeric antigen receptor (CAR) T-cell therapy with CD28 co-stimulation developed by Kyverna Therapeutics. The therapy works by extracting a patient's own T cells via leukapheresis, genetically modifying them to express a CAR that recognizes and targets CD19-positive B cells, and then reinfusing the engineered cells back into the patient. This mechanism enables the elimination of CD19-positive B cells and resets the immune system, offering a potential one-time treatment with durable effects due to the CD28 co-stimulatory domain, which enhances therapeutic cell persistence and potency. The drug is in late-stage development for stiff person syndrome, with a registrational Phase 2 trial (KYSA-8) demonstrating highly statistically significant improvements in mobility and disability, and is also being investigated for generalized myasthenia gravis.

Brand names

KYV-101KYV101KYV 101

Other names

miv-cel