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Abstract Details

Update on the Phase Two Portion of KYSA-6, an Open-label, Single-arm, Multicenter Study of KYV-101, a Fully Human CD19 Chimeric Antigen Receptor (CAR) T-cell Therapy in Generalized Myasthenia Gravis (gMG)
Neuromuscular and Clinical Neurophysiology (EMG)
S14 - Updates on Myasthenia Gravis (1:48 PM-2:00 PM)
005
Evaluate clinical outcomes with KYV-101 in patients with gMG.
MG is a B-cell and antibody-mediated neuromuscular autoimmune disease that can result in substantial disability. Novel therapies that provide greater absolute reduction in MG Activities of Daily Living (MG-ADL) to minimize or eliminate disease symptoms are needed. KYV-101 is a fully human, autologous CD19 CAR T-cell therapy with CD28 costimulation, designed for potency and tolerability. With a single dose, KYV-101 has potential to achieve deep B-cell depletion and immune reset to deliver durable, drug-free, disease-free remission. This is an update of KYSA-6 (NCT06193889) a phase 2, open-label, single-arm, multicenter study of KYV-101 in gMG.
Adults (18-75y) with gMG (MGFA class IIb-IV), history of AChR or MuSK autoantibodies, MG-ADL score ≥6, and ≥2 immunosuppressant/immunomodulator failures, received lymphodepletion and a single infusion of 1×108 CAR T cells.
As of October 3, 2025, 6 patients were dosed (mean [range]: age 45.5y [21-62]; MG-ADL 11.2 [7-16]; quantitative MG [QMG] 17.3 [9-28]). Follow-up ranged from 28 days to 9 months; 3 had ≥24-weeks follow-up. Robust CAR T-cell expansion and B-cell depletion occurred in all patients. With a single dose, 100% of patients had ≥3-point improvement in MG-ADL from baseline with 50% achieving minimal symptom expression (MG-ADL ≤1) at last follow-up. At 24-weeks, KYV-101 treatment resulted in 8.0-point (range, 7-9) and 7.7-point (range, 5-11) mean reductions from baseline in MG-ADL and QMG scores, respectively. Of the 6 patients, 5 became nonsteroidal immunosuppressant therapy-free. No ICANS and no high-grade CRS events occurred.
These findings support the potential of KYV-101 to deliver durable, drug-free, disease-free remission in patients with moderate to severe MG. KYV-101 treatment resulted in robust and sustained improvements in disease severity with an acceptable safety profile, while eliminating background immunosuppressants in the majority of patients. Phase 3 is ongoing; updated phase 2 follow-up will be presented.
Authors/Disclosures
Srikanth Muppidi, MD, FAAN
PRESENTER 		Dr. Muppidi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Alexion. Dr. Muppidi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for argenx. Dr. Muppidi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for UCB/Ra Pharma. Dr. Muppidi has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Horizont Pharma. Dr. Muppidi has received personal compensation in the range of $500-$4,999 for serving as a Consultant for J & J pharma. Dr. Muppidi has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Dianthus Pharma. Dr. Muppidi has received publishing royalties from a publication relating to health care.
Michael C. Hunter, MD (Intermountain Healthcare) Dr. Hunter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Amgen. Dr. Hunter has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Amgen.
Sarah Hoffmann, MD, PhD Prof. Hoffmann has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Alexion. Prof. Hoffmann has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx. Prof. Hoffmann has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Prof. Hoffmann has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Alexion. Prof. Hoffmann has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Argenx. Prof. Hoffmann has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Roche. Prof. Hoffmann has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Grifols. The institution of Prof. Hoffmann has received research support from Janssen. The institution of Prof. Hoffmann has received research support from Argenx.
Tobias Hegelmaier Tobias Hegelmaier has nothing to disclose.
Jeremias Motte, MD (UK RUB- St. Josef-Hospital) The institution of Prof. Motte has received research support from Ruhr-Univerity Bochum.
Ralf Gold, MD (Neurologische Universitaetsklinik) Dr. Gold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Biogen . Dr. Gold has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Novartis. Dr. Gold has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Roche. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Genzyme. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bayer Vital. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Eisai Pharamaceuticals. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Biogen. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Gold has received personal compensation in the range of $10,000-$49,999 for serving as an Editor, Associate Editor, or Editorial Advisory Board Member for SAGE Publishers. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Novartis. Dr. Gold has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Biogen. The institution of Dr. Gold has received research support from Novartis. The institution of Dr. Gold has received research support from Biogen.
Charlotte Schubert, MD Mrs. Schubert has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Argenx, Alexion, Johnson&Johnson. Mrs. Schubert has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Alexion, Argenx.
Bradley Hunter, MD Dr. Hunter has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Kite Pharma. Dr. Hunter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for BMS. Dr. Hunter has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Novartis. Dr. Hunter has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Johnson & Johnson. Dr. Hunter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Caribou Biosciences. Dr. Hunter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for In8 Bio. Dr. Hunter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda. Dr. Hunter has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Regeneron. Dr. Hunter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Johnson & Johnson. Dr. Hunter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Poseida Therapeutics . Dr. Hunter has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Kite Pharma. Dr. Hunter has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for AbbVie/Genmab. Dr. Hunter has stock in Actinium Pharmaseuticals. The institution of Dr. Hunter has received research support from Johnson & Johnson.
Everett Meyer (Stanford University) No disclosure on file
Marie Luise Hütter-Krönke, MD Dr. Hütter-Krönke has nothing to disclose.
Christian R. Schultze-Florey, MD Dr. Schultze-Florey has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. Dr. Schultze-Florey has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pfizer. Dr. Schultze-Florey has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sobi. Dr. Schultze-Florey has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Pierre Fabre. Dr. Schultze-Florey has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Gilead. Dr. Schultze-Florey has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Mikrogen. Dr. Schultze-Florey has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Roche. Dr. Schultze-Florey has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Johnson&Johnson. Dr. Schultze-Florey has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Takeda.
Roland Schroers Roland Schroers has received personal compensation in the range of $500-$4,999 for serving as a Consultant for KYVERNA.
Francis A. Ayuk, MD Prof. Ayuk has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Kite/Giliead. Prof. Ayuk has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Janssen. Prof. Ayuk has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for BMS. Prof. Ayuk has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Miltenyi Biomedicine. Prof. Ayuk has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for AbbVie. Prof. Ayuk has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Therakos. The institution of Prof. Ayuk has received research support from Therakos. The institution of Prof. Ayuk has received research support from Neovii.
Justin Chou, PhD Dr. Chou has received personal compensation for serving as an employee of Kyverna Therapeutics. Dr. Chou has received intellectual property interests from a discovery or technology relating to health care.
Baodong Xing, PhD Mr. Xing has nothing to disclose.
Naji Gehchan Dr. Gehchan has received personal compensation for serving as an employee of Kyverna Tx. Dr. Gehchan has received personal compensation for serving as an employee of Eli Lilly. Dr. Gehchan has stock in Eli Lilly.
Aiden Haghikia, MD (Hannover Medical School) Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Merck Serono. The institution of Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Sanofi. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Galapagos. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Merck Serono. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Kyverna. Dr. Haghikia has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for Roche. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Novartis. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Janssen. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Bayer. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Neuraxpharm. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving as a speaker with Biogen. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving as a speaker with Sanofi. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving as a speaker with Novartis. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving as a speaker with Merck Serono. Dr. Haghikia has received personal compensation in the range of $500-$4,999 for serving as a speaker with Celgene.