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

ConditionsMyasthenia GravisGeneralized Myasthenia Gravis
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKyverna Therapeutics

About this trial

A Study of the Anti-CD 19 Chimeric Antigen Receptor T Cell Therapy for Patients with Myasthenia Gravis

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Presence of autoantibodies to AChR or MuSK

Myasthenia Gravis Foundation of America (MGFA) Class II-IV

MG-Activities of Daily Living (MG-ADL) total score of ≥6 at screening and confirmed at baseline visit

QMG total score of ≥11 at screening an confirmed at baseline visit

Disqualifiers

Unable to washout or interrupt autoimmune disease therapy prior to apheresis and/or baseline if required

Co-occurring neurological autoimmune disease (ie, Lambert-Eaton Myasthenic Syndrome) or any disease affecting the neuromuscular junction or muscle causing weakness (eg, myositis, myopathy, motor neuropathy)

History of stroke (with residual sequalae and/or risk for recurrence), seizure (even if well controlled on antiepileptics), neurodegenerative disease, altered mental status (unexplained and/or recent/current), or uncontrolled/severe psychiatric disease

Any serious and/or uncontrolled medical condition that, in the investigator's judgment, would cause unacceptable safety risk, interfere with study procedures or results, or compromise compliance with the protocol, including but not limited to, clinically significant cardiac or pulmonary disease

Trial design

Design model

Single group

Treatments tested in this trial

  • Standard of Care Treatment

    Drug

    Standard of Care Medications Optional Crossover to receive KYV-101 treatment

  • Standard lymphodepletion regimen

    Drug

    Standard lymphodepletion regimen

  • KYV-101

    Biological/Vaccine

    Anti-CD19 CAR-T cell therapy

Treatment groups

66 Participants
are divided into 3 treatment groups
Group A: KYV-101 CAR-T cells with lymphodepletion conditioningExperimental treatment 2 interventions
Group B: KYV-101 TreatmentExperimental treatment 2 interventions
Group C: Standard of CareActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Incidence and severity of adverse events (AEs) and laboratory abnormalities (Phase 2)

Time frame
18 months
2

Efficacy of KYV-101 via Myasthenia Gravis Activities of Daily Living (MG-ADL) change from baseline (Phase 2)

Time frame
24 weeks
3

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)

Time frame
24 weeks
4

Efficacy of KYV-101 via Quantitative Myasthenia Gravis (QMG) change from baseline for KYV-101 Treatment arm to Standard of Care arm (Phase 3)

Time frame
24 weeks

Secondary outcomes

1

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)

Time frame
24 weeks
2

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)

Time frame
24 weeks
3

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)

Time frame
24 weeks
4

Efficacy of KYV-101 via Proportion of patients with a ≥3 point improvement from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) for KYV-101 Treatment arm to Standard of Care arm (Phase 3)

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kyverna Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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