Early Phase 1 Myasthenia Gravis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have given written agreement to take part and are willing and able to follow the study procedures (or have a legal representative who has done so on their behalf)
• People aged 18 to 75 years old (inclusive), of any sex
• People who have been diagnosed with refractory generalised Myasthenia Gravis (a persistent, hard-to-treat form of MG affecting more than just the eyes) classified at a moderate to severe level using a standard medical grading system called the MGFA classification
• People whose MG symptoms score at least 6 points on a standard daily living impact scale (MG-ADL), where eye-related symptoms make up less than half of that score, and who also score at least 11 on another standard MG severity scale (QMG)
• People whose MG has not responded well enough to standard treatments such as steroids, immune-suppressing medicines, or certain biological medicines, and who remain at risk of worsening
• People taking steroid medications (such as prednisone) at a stable dose of no more than 30 mg per day (or equivalent) for at least 4 weeks before the treatment infusion
• People whose blood test results during the screening period fall within acceptable ranges for blood cell counts, liver function, kidney function, blood clotting, and heart function (confirm specific values with trial site)
• Women of childbearing potential who have a negative pregnancy test at screening and who agree not to breastfeed for at least 1 year after the study treatment infusion (or until CAR-T cells are no longer detectable, whichever is later)
• People who agree to use effective contraception from the screening period until at least 2 years after the study treatment infusion (or until CAR-T cells are no longer detectable, whichever is later); male participants must also agree to use condoms during any sexual contact with women who are pregnant or could become pregnant within that period, even after a vasectomy
• People from whom blood can be collected through a vein without difficulty, and who have no medical reason preventing white blood cell collection

Who may not be able to join:

• People with a history of severe allergic reactions or serious hypersensitivity
• People who have a known allergy or medical reason to avoid the medicines fludarabine or cyclophosphamide, or any ingredient in the study treatment
• People who have received intravenous immunoglobulin, plasma exchange, or immunoadsorption therapy within 4 weeks before the treatment infusion
• People who have received a CD20-targeting medicine (such as rituximab) within 6 months before the white blood cell collection procedure
• People who have taken tacrolimus, cyclosporine, azathioprine, or mycophenolate mofetil within 1 week before the white blood cell collection procedure
• People who have received a type of medicine called an FcRn antagonist within 1 week before the white blood cell collection procedure
• People who have received complement inhibitor medicines (such as eculizumab) within 1 week before the white blood cell collection procedure
• People with significant heart conditions, including severe heart failure, recent heart attack or major heart surgery within 6 months, serious irregular heart rhythms, unexplained fainting episodes, certain abnormal heart electrical readings, a history of severe non-ischemic cardiomyopathy, or other serious heart abnormalities assessed as unsuitable by the study doctor
• People with an active or uncontrolled cancer (certain early-stage or skin-limited cancers that have been fully treated may still be eligible — confirm with trial site)
• People with serious underlying health conditions, including uncontrolled infections (such as active tuberculosis), significant dementia or changes in mental state, or a history of neurological conditions such as epilepsy, stroke, Parkinson's disease, paralysis, or serious mental illness
• People who test positive for HIV, active hepatitis B, hepatitis C with detectable virus levels, or syphilis (certain hepatitis B or C cases managed with antiviral treatment may still be considered — confirm with trial site)
• People who have previously received any CAR-T cell therapy
• People who have previously had an organ transplant or bone marrow transplant from a donor
• People who have had surgery within 2 weeks before the preparatory treatment phase, or who plan to have surgery during the study (minor procedures under local anaesthetic may be considered, except within 2 weeks of the infusion — confirm with trial site)
• People who have received a live vaccine within 4 weeks before the preparatory treatment phase
• People who have taken part in another clinical trial within 4 weeks of signing the consent form, or within 5 half-lives of the last dose from that trial (whichever is the longer period)
• Women who are pregnant or breastfeeding and do not agree to stop breastfeeding, and people with plans to start a family within 1 year of receiving the study treatment
• People who are currently assessed as having active thoughts of suicide or self-harm based on a standard assessment scale, or who have a recent history of suicidal behaviour
• People who, in the study doctor's judgement, have circumstances that could prevent full trial participation, affect the trial results, or for whom participation would not be in their best interest

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