Kyverna Therapeutics has announced positive Phase II interim results showing 100% response rate in six patients with generalised myasthenia gravis (gMG) treated with CD19-directed CAR-T therapy KYV-101, demonstrating significant improvement in MG-ADL scale and QMG scores. All patients achieved clinically meaningful reduction of at least 3 points on both scales with average 8-point improvement at 24 weeks and two of three patients reaching minimal symptom expression (MSE) state. The therapy enabled complete discontinuation of immunosuppressants, high-dose steroids and FcRn inhibitors with no grade three or higher cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) events reported.

The autologous cell therapy enables deep B-cell depletion and immune system reset through single administration, addressing a severe autoimmune condition where 20% of patients experience life-threatening respiratory crises. Kyverna chief medical officer Naji Gehchan highlighted rapid onset within two weeks and sustained benefit, supporting a planned Phase III trial initiation by year-end. The registrational programme aims to demonstrate drug-free disease-free remission in B-cell-mediated autoimmune disorders including lupus nephritis and systemic sclerosis, following breakthrough therapy designation (BTD) from US regulatory authorities for gMG.