Phase 1 Myasthenia Gravis Trial, Recruiting
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.
Contact this trial
Principal Investigator: Kite Study Director, Kite, A Gilead Company
Phone: 844-454-5483(1-844-454-KITE)
Australian sites
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
Where this trial is recruiting
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?
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.