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Standard of Care Treatment

Phase 2

Myasthenia Gravis | Small molecule | Neurology |Kyverna Therapeutics, Inc.|Last Updated: May 15, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment66
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06193889KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia GravisPHASE2 RECRUITING 66 — — Aug 28, 2024Sep 1, 2028May 15, 202617 United States, Australia +2
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Study Endpoints
Primary Endpoints
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
Secondary Endpoints
Efficacy of KYV-101 via Myasthenia Gravis Composite (MGC) score change from baseline for KYV-101 Treatment arm to Standard of Care arm (Phase 3)
24 weeks
Efficacy of KYV-101 via Percent change from baseline in anti acetylcholine receptors (anti-AChR) antibody levels for KYV-101 Treatment arm to Standard of Care arm (Phase 3)
24 weeks
Efficacy of KYV-101 via Percent change from baseline in anti muscle-specific tyrosine kinase (anti-MuSK) antibody levels for KYV-101 Treatment arm to Standard of Care arm (Phase 3)
24 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
KYV-101 CAR-T cells with lymphodepletion conditioningEXPERIMENTALPhase 2: Dosing with KYV-101 CAR-T cells
KYV-101 TreatmentEXPERIMENTALPhase 3
Standard of CareACTIVE_COMPARATORPhase 3 Optional crossover to receive KYV-101 Treatment after 24 weeks
Interventions
NameTypeDescription
Standard of Care TreatmentDRUGStandard of Care Medications Optional Crossover to receive KYV-101 treatment
Standard lymphodepletion regimenDRUGStandard lymphodepletion regimen
KYV-101BIOLOGICALAnti-CD19 CAR-T cell therapy
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites17

Key Inclusion Criteria 1. Presence of autoantibodies to AChR or MuSK 2. Myasthenia Gravis Foundation of America (MGFA) Class II-IV 3. MG-Activities of Daily Living (MG-ADL) total score of ≥6 at screening and confirmed at baseline visit 4. QMG total score of ≥11 at screening an confirmed at baseline...

Countries:United StatesAustraliaBrazilGermany
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Competitive Landscape -Myasthenia Gravis 49 trials
CompanyTickerTrialsLead PhaseDrugs
argenx SE Sponsored ADRARGX13PHASE3Efgartigimod, Efgartigimod PH20, efgartigimod administration, Efgartigimod or Efgartigimod PH20, Empasiprubart
AstraZeneca PLCAZN9PHASE3Ravulizumab, ALXN1720, Gefurulimab, Ultomiris
Novartis AG Sponsored ADRNVS3PHASE3Remibrutinib, Iptacopan, YTB323
Johnson & JohnsonJNJ3PHASE3Nipocalimab, Efgartigimod, Nipocalimab -LIV
Amgen Inc.AMGN2PHASE3inebilizumab, Inebilizumab
Regeneron Pharmaceuticals, Inc.REGN1PHASE3Pozelimab + Cemdisiran, Cemdisiran
Immunovant IncIMVT2PHASE3Batoclimab weekly, Batoclimab bi-weekly, IMVT-1402
Cartesian Therapeutics, Inc.RNAC3PHASE3Decartes-08, Descartes-08
Vor Biopharma, Inc.VOR1PHASE3Telitacicept
Dianthus Therapeutics, Inc.DNTH1PHASE2DNTH103
Kyverna Therapeutics, Inc.KYTX2PHASE2Standard lymphodepletion regimen, KYV-101
Bristol-Myers Squibb CompanyBMY1PHASE1CC-97540, Fludarabine, Cyclophosphamide
Vertex Pharmaceuticals IncorporatedVRTX1PHASE2Povetacicept
Gilead Sciences, Inc.GILD1PHASE1KITE-363, Fludarabine, Cyclophosphamide
Arcellx, Inc.ACLX1PHASE1anito-cel, Standard Lymphodepletion regimen
Cabaletta Bio, Inc.CABA1PHASE1CABA-201
Intuitive Surgical, Inc.ISRG1NAUndisclosed
Aurinia Pharmaceuticals Inc.AUPH1PHASE1Aritinercept
Smith & Nephew plc Sponsored ADRSNN1 — Undisclosed
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06193889primaryCompletionDate: changed
LOWMay 24, 2026NCT06193889studyFirstPostDate: changed