Phase 1 Myasthenia Gravis Trial, Recruiting NCT07304154 Sponsor: Kite, A Gilead Company Condition: Myasthenia Gravis
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Phase 1 Myasthenia Gravis Trial, Recruiting

NCT07304154
Recruiting Phase 1 🇦🇺 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:

For Multiple Sclerosis (MS):

  • You have been diagnosed with MS (any form, including relapsing or progressive) using recognised medical guidelines (2017 McDonald criteria)
  • For relapsing forms of MS: your MS has continued to be active despite being on a strong MS treatment, OR you have been unable to tolerate at least 2 MS treatments due to side effects
  • For relapsing forms of MS: your level of disability falls within a specific range on a standard MS scale (EDSS score 0 to 5.5)
  • For progressive forms of MS (non-active or primary progressive): your disease has continued to worsen over the past 12 months despite standard treatment
  • For progressive forms of MS: you have had no relapses for at least 2 years
  • For progressive forms of MS: a recent brain scan showed no signs of active inflammation (no gadolinium-enhancing lesions)
  • For progressive forms of MS: your disability level falls within a specific range and you are still able to walk (EDSS 3 to 6.5)

For Myasthenia Gravis (MG):

  • You have test results confirming specific antibodies linked to MG (against AChR, MuSK, or LRP4)
  • Your MG causes generalised muscle weakness (not just eye symptoms), classified at a moderate to severe level (MGFA class II–IV)
  • Your MG symptoms significantly affect your daily life, as measured by specific scoring tools (MG-ADL score of 6 or more, QMG score of 10 or more)
  • Your MG has not responded well enough to at least 2 different types of immune-suppressing treatments
  • If you have had thymus gland surgery, it must have been completed at least 12 months before joining the trial
  • You must be willing to use contraception methods specified by the trial, if this applies to you

For Chronic Inflammatory Demyelinating Polyneuropathy (CIDP):

  • You have a confirmed or probable diagnosis of CIDP (relapsing or progressive form) based on recognised medical guidelines
  • Your CIDP symptoms are active enough to meet specific scoring thresholds (CDAS score of 3 or more, INCAT score of 3 or more)
  • Your CIDP has not responded well enough to standard treatments, OR you have been unable to tolerate standard treatments due to side effects
  • There is documented evidence that your condition improved with certain treatments in the past 2 years, or worsened when those treatments were reduced or stopped (except for certain subtypes of CIDP)

Who may not be able to join:

General (all conditions):

  • You have a history of, or currently have, another condition affecting the brain or nerves that could affect thinking, strength, or cause weakness
  • You have previously had a stem cell transplant (using your own or a donor's cells) or an organ transplant

For MS specifically:

  • You are unable to complete certain physical tests within required time limits (a pegboard hand test in under 240 seconds and a 25-foot walk test in under 150 seconds) — applies to certain groups within the trial
  • You have had a serious allergic reaction to gadolinium contrast dye (used in MRI scans)
  • You have a kidney condition that would prevent you from safely receiving gadolinium dye
  • You have a medical reason that means you cannot safely have a lumbar puncture (spinal tap)

For MG specifically:

  • You are currently in a myasthenic crisis (severe sudden worsening) that has not been brought under control within 2 weeks before joining
  • You have had thymus gland surgery within the past 12 months

For CIDP specifically:

  • Your CIDP affects only your sense of feeling (pure sensory CIDP) or only one specific area of the body (focal CIDP)
  • Your nerve problems are caused by something other than CIDP

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

(Note: Additional eligibility criteria not listed here may also apply — the trial site can provide full details.)

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 1: approximately ~10% 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: Kite Study Director, Kite, A Gilead Company

Phone: 844-454-5483(1-844-454-KITE)

Australian sites

Concord Repatriation General Hospital, Sydney, New South Wales
Corner Hawkesbury Road and Darcy Road, Westmead, New South Wales

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 1
Sponsor
Kite, A Gilead Company
Registry
ClinicalTrials.gov
Start date
10 April 2026
Est. completion
1 June 2029

Where this trial is recruiting

🇦🇺 Australia 🇺🇸 United States

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

Primary endpoints

Phase 1a: Percentage of Participants Experiencing Treatment-emergent Adverse Event (TEAEs); Phase 1a: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363; Phase 1b: (All Cohorts) Percentage of Participants Experiencing TEAEs; Phase 1b: Relapsing Forms of MS (RRMS) and (aSPMS): Number of New T1 Gadolinium Enhancing (GadE+) Lesions on Magnetic Resonance Imaging (MRI) at Week 12; Phase 1b: Relapsing Forms of MS (RRMS and aSPMS): Number of New and/or Enlarging T2 Lesions on MRI at Week 12; Phase 1b: Progressive Forms of MS (PPMS) and (naSPMS): Tim...

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