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Standard of Care Treatment

Phase 2

Myasthenia Gravis | Small molecule | Neurology |Kyverna Therapeutics, Inc.|Last Updated: Jul 29, 2026

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment66

FDA Designations

No designations recorded

Clinical trial landscape

Standard of Care Treatment · 1 trial · 2 indications

Phase 2 1
NCT06193889KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia GravisMyasthenia Gravis
RECRUITING66 Analytics
PHASE2RECRUITING
KYSA-6: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell Therapy, in Patients With Generalized Myasthenia Gravis
Myasthenia GravisUnlock trial analytics

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 to 75 Years
SexALL
Healthy VolunteersNo
Study Sites22

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 StatesAustraliaBrazilGermanySaudi ArabiaUnited Kingdom
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Recent Changes (Last 90 Days)

LOWJul 29, 2026NCT06193889lastUpdatePostDate: changed
LOWJul 29, 2026NCT06193889lastUpdatePostDate: changed
LOWJul 8, 2026NCT06193889lastUpdatePostDate: changed
LOWJul 8, 2026NCT06193889lastUpdatePostDate: changed

Frequently asked questions about Standard of Care Treatment

What is Standard of Care Treatment used for in Myasthenia Gravis?

Standard of Care Treatment is being studied for use in Myasthenia Gravis, specifically generalized myasthenia gravis. It is an investigational therapy currently in Phase 2 clinical development. The treatment is being evaluated in a clinical trial enrolling patients with this condition.

Who makes Standard of Care Treatment?

Standard of Care Treatment is being developed by Kyverna Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol KYTX. The company is conducting clinical research on this therapy for the treatment of myasthenia gravis.

What phase is Standard of Care Treatment in?

Standard of Care Treatment is currently in Phase 2 clinical development. It is an investigational therapy, meaning it has not been approved by regulatory authorities. The ongoing Phase 2 trial is actively recruiting participants to evaluate the treatment for generalized myasthenia gravis.

What clinical trials is Standard of Care Treatment in?

Standard of Care Treatment is being studied in a Phase 2 clinical trial with the identifier NCT06193889. This trial, titled KYSA-6, is recruiting patients with generalized myasthenia gravis. The study is active and enrolling participants in multiple countries including the United States, Australia, Brazil, Germany, Saudi Arabia, and the United Kingdom.

Is Standard of Care Treatment the same as KYSA-6?

Standard of Care Treatment is not the same as KYSA-6. KYSA-6 is the name of the clinical trial, not the drug itself. The trial, identified as NCT06193889, is evaluating Standard of Care Treatment in patients with generalized myasthenia gravis. The drug is being developed by Kyverna Therapeutics.