RecruitingPhase 2/3

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

United States, Australia, Brazil66 participantsStarted 2024-08-28

Plain-language summary

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

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. Failed treatment with 2 or more immunosuppressive/immunomodulatory therapies, or failed at least 1 immunosuppressive therapy and required chronic plasmapheresis, or IVIG (or subcutaneous or intramuscular Ig) to control symptoms
. On a stable dose of glucocorticoids and/or other immunotherapies for ≥1 month prior to screening. For patients treated with azathioprine, a stable dose for ≥2 months prior to screening is required
. No change in dose of acetylcholinesterase inhibitors for ≥2 weeks prior to screening
. No use of intravenous immune globulin (IVIG) or plasmapheresis (PLEX) within 4 weeks of screening or pre-dose baseline (unless this is part of their SOC treatment regimen)

Exclusion criteria

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 18 months

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

Timeframe: 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)

Timeframe: 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)

Timeframe: 24 weeks

Trial details

NCT IDNCT06193889

SponsorKyverna Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09

Contact for this trial

Kyverna Therapeutics, Inc.

510-925-2484 Clinicaltrials@kyvernatx.com

View on ClinicalTrials.gov More Myasthenia Gravis trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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
. Failed treatment with 2 or more immunosuppressive/immunomodulatory therapies, or failed at least 1 immunosuppressive therapy and required chronic plasmapheresis, or IVIG (or subcutaneous or intramuscular Ig) to control symptoms
. On a stable dose of glucocorticoids and/or other immunotherapies for ≥1 month prior to screening. For patients treated with azathioprine, a stable dose for ≥2 months prior to screening is required
. No change in dose of acetylcholinesterase inhibitors for ≥2 weeks prior to screening
. No use of intravenous immune globulin (IVIG) or plasmapheresis (PLEX) within 4 weeks of screening or pre-dose baseline (unless this is part of their SOC treatment regimen)

Exclusion criteria

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

What they're measuring

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

Timeframe: 18 months

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

Timeframe: 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)

Timeframe: 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)

Timeframe: 24 weeks