KYSA-6: A Study of KYV-101 for Generalized Myasthenia Gravis

This study, called KYSA-6, is looking at a treatment called KYV-101 for people with generalized myasthenia gravis (a chronic autoimmune disease causing muscle weakness). KYV-101 is a type of CAR T-cell therapy that targets CD19, aiming to reduce the B cells that play a role in myasthenia gravis. The study will compare KYV-101 to standard care. To join, you must be between 18 and 75 years old, have specific autoantibodies (AChR or MuSK), and certain scores on MG-ADL and QMG tests. Researchers will measure how safe KYV-101 is over 18 months and how well it improves daily activities (MG-ADL scores) over 24 weeks. The study is currently recruiting 66 participants, but its status is unclear.

Study design
This interventional study plans to enroll 66 participants. It compares KYV-101 treatment to standard of care, with an optional crossover for standard care participants to receive KYV-101.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will track safety for 18 months and measure treatment effectiveness for 24 weeks.

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NCT06193889

KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis

Recruiting
PHASE2Ages 18–75InterventionalTreatment
Kyverna Therapeutics
~66 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Standard of Care TreatmentStandard lymphodepletion regimenKYV-101

At a glance

Recruiting sites
22 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of adverse events (AEs) and laboratory abnormalities (Phase 2)
Measured over 18 months
+3 more outcomes measured
Myasthenia Gravis
Generalized Myasthenia Gravis
22 sites across 13 states
Germany7
California3
United Kingdom2
Florida1
Indiana1
Missouri1
Oregon1
Pennsylvania1
  • MD · STUDY_DIRECTOR · Kyverna Therapeutics, Inc.

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  • Incidence and severity of adverse events (AEs) and laboratory abnormalities (Phase 2)18 months
  • Efficacy of KYV-101 via Myasthenia Gravis Activities of Daily Living (MG-ADL) change from baseline (Phase 2)24 weeks
  • Efficacy of KYV-101 via Myasthenia Gravis Activities of Daily Living (MG-ADL) change from baseline for KYV-101 Treatment arm to Standard of Care arm (Phase 3)24 weeks
  • Efficacy of KYV-101 via Quantitative Myasthenia Gravis (QMG) change from baseline for KYV-101 Treatment arm to Standard of Care arm (Phase 3)24 weeks