The bet that B cell-depleting CAR-T could treat autoimmune disease is old enough now that the question isn’t so much “does it work.” The real question now is “does it keep working.”
At the AAN Annual Meeting this week, Kyverna Therapeutics presented 52-week follow-up data for miv-cel (mivocabtagene autoleucel, KYV-101), its autologous CD19 CAR-T, in generalized myasthenia gravis.
It’s a single infusion. Stock standard at this point.
Improvements across both the MG-ADL and QMG clinical scales at one year. Every patient in the follow-up cohort showed improvement.
Specific numbers weren’t broken out in the readout.
What Kyverna did disclose is that the data supports confidence in its ongoing Phase 3 program, KYSA-6, which is actively enrolling 60 patients to compare miv-cel to standard of care.
miv-cel vs. existing MG therapies (QMG reduction)
-7.7 pts
-6.2 pts
-2.8 pts
Prior Kyverna disclosures. One-time dose vs. chronic dosing.
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The thing that makes 52-week follow-up matter more than the initial response is durability.
MG patients on Uplizna (inebilizumab) and Vyvgart (efgartigimod) are on lifetime therapy. Infusion after infusion. Descartes-08, Cartesian’s RNA-based CAR-T, got FDA Fast Track but still uses multiple doses.
The Kyverna pitch has always been: one infusion, reset the immune system, patient is off maintenance therapy indefinitely.
At one year, miv-cel patients are, by Kyverna’s account, still improved. B cell repopulation happens around day 132, but the improvement sticks. That’s the fingerprint of a true immune reset rather than temporary B cell depletion.
For context on the broader field, look at our recent piece on Allogene — off-the-shelf CAR-T is coming fast, and Kyverna’s own pipeline includes an allogeneic version (KYV-201) built with Intellia’s CRISPR tech.
Kyverna is already in Phase 3 in stiff person syndrome with a BLA filing planned for H1 2026. If the MG Phase 3 reads out with similar durability to this 52-week data, Kyverna has two registrational shots on goal within 18 months. For an autoimmune CAR-T pure-play, that’s a real setup.
