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News
A single infusion of miv-cel, a CD19-targeting CAR-T therapy, produced durable improvements in generalized myasthenia gravis patients lasting up to 1.5 years. All seven trial participants showed meaningful symptom reductions at 24 weeks and were able to stop immunosuppressive therapies entirely. The therapy's safety profile was favorable, with no severe cytokine release syndrome or neurotoxicity reported.
A single infusion of mivocabtagene autoleucel (miv-cel), a fully human CD19-targeting CAR-T cell therapy, is showing remarkable staying power in patients with generalized myasthenia gravis (gMG). Data from the phase II portion of the KYSA-6 trial, presented at the 2026 AANEM meeting, showed that all seven participants sustained clinically meaningful symptom improvements at 24 weeks — and five patients maintained those gains at the one-year mark.
Perhaps most striking: all patients were able to discontinue immunosuppressive therapies — including high-dose steroids, FcRn inhibitors, and complement inhibitors — and stay off them. At last follow-up, 57% of patients had minimal symptom expression, and evidence of immune reset was observed, with pathogenic antibodies declining while protective antibodies remained intact.
By the Numbers:
Why it matters: Myasthenia gravis is a chronic, often debilitating autoimmune disease with limited treatment options for refractory patients. A single-dose therapy that can put the disease into long-term remission — without ongoing immunosuppression — could be transformative. A phase III randomized trial comparing miv-cel to standard care is now underway, with enrollment expected to complete in mid-2027.
