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News
A single infusion of KYV-101 (miv-cel), a CD19-targeting CAR T-cell therapy, produced durable, drug-free responses in patients with generalized myasthenia gravis (gMG) at one year, according to new KYSA-6 trial data. Over half of evaluable patients achieved minimal symptom expression, and 86% remained off immunosuppressants. Parallel one-year data from the KYSA-8 trial in stiff person syndrome showed similarly impressive results, with 95% of responders sustaining benefit.
A single infusion of KYV-101 (miv-cel), Kyverna Therapeutics' autologous CD19-targeting CAR T-cell therapy, is showing remarkable staying power in two serious autoimmune neurologic diseases. One-year data from the phase 2/3 KYSA-6 trial in generalized myasthenia gravis (gMG) revealed that all 7 treated patients — who had previously failed multiple immunosuppressant therapies — achieved clinically meaningful symptom improvement at 24 weeks, with those gains holding at the one-year mark. Crucially, 86% remained completely off immunosuppressants at last follow-up, and the safety profile was clean, with no high-grade cytokine release syndrome or serious neurotoxicity events.
The one-year data from KYSA-8 in stiff person syndrome (SPS) were equally compelling. Among 26 enrolled patients, walking speed improved by a median of 49% at month 12, 95% of initial responders sustained their benefit, and 92% remained free of chronic SPS immunotherapies — a striking result in a disease with no currently approved treatments.
By the Numbers
Why it matters: These results position KYV-101 as a potential game-changer for refractory autoimmune neurologic diseases, offering patients a single-dose path to long-term, drug-free remission. With a rolling BLA for SPS on track for Q4 2026 and phase 3 gMG enrollment underway, regulatory approval could be on the horizon.
