Phase 3 Myasthenia Gravis Trial, Recruiting NCT06193889 Sponsor: Kyverna Therapeutics Condition: Myasthenia Gravis
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Phase 3 Myasthenia Gravis Trial, Recruiting

NCT06193889
Recruiting Phase 3 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Your blood tests show specific antibodies linked to myasthenia gravis (called AChR or MuSK antibodies)
  • Your myasthenia gravis has been rated as moderate to severe by your doctor (classified as MGFA Class II–IV)
  • Your symptoms score at least 6 out of 24 on a standard daily activities questionnaire at the start of the study
  • Your muscle weakness scores at least 11 out of 39 on a standard strength test at the start of the study
  • You have tried at least 2 immune-suppressing treatments that did not work well enough, OR tried at least 1 and also needed regular plasma exchange or immunoglobulin infusions to manage your symptoms
  • You have been on a stable dose of steroids or other immune treatments for at least 1 month before screening (or at least 2 months if you take azathioprine)
  • Your dose of muscle-strength medication (such as pyridostigmine) has not changed in the last 2 weeks before screening
  • You have not had an immunoglobulin infusion or plasma exchange in the 4 weeks before screening (unless it is part of your regular ongoing treatment)
  • You have not received rituximab or similar antibody treatments in the 12 weeks before screening
  • You are able and willing to attend all required visits at the study site

Who may not be able to join:

  • You are unable to temporarily stop certain autoimmune treatments before the study procedures if required
  • You have another nerve or muscle condition alongside myasthenia gravis, such as Lambert-Eaton syndrome, myositis, or motor nerve disease
  • You have a history of stroke with lasting effects or risk of recurrence, seizures, a degenerative brain condition, unexplained changes in mental status, or severe uncontrolled psychiatric illness
  • You have a serious uncontrolled medical condition — such as a significant heart or lung disease — that the study doctor believes could put you at risk or interfere with the study
  • You have a history of a primary immune deficiency, an organ or bone marrow transplant, or have had your spleen removed
  • You have an active or uncontrolled infection (viral, bacterial, or fungal), or a history of frequent repeated infections
  • You had your thymus removed less than 12 months before screening, or plan to have it removed during the study
  • You have previously received gene therapy or a cell-based immune treatment such as CAR-T therapy
  • You require ongoing blood-thinning (anticoagulant) medication that cannot be safely stopped for medical procedures

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: MD, Kyverna Therapeutics, Inc.

Phone: 510-925-2484

Australian sites

Westmead Institute for Medical Research, Westmead,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Sponsor
Kyverna Therapeutics
Registry
ClinicalTrials.gov
Start date
28 August 2024
Est. completion
1 September 2027

Where this trial is recruiting

🇦🇺 Australia 🇧🇷 Brazil 🇩🇪 Germany 🇸🇦 Saudi Arabia 🇬🇧 United Kingdom 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov