Phase 1 Myasthenia Gravis Trial, Recruiting

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

Who might be able to join this trial:

• You are between 18 and 65 years old.
• You have been diagnosed with generalized myasthenia gravis (MG), a muscle weakness condition, at a moderate to severe level (classified as MGFA grade II–IV).
• Your myasthenia gravis is considered "refractory," meaning it has not responded well enough to standard treatments.
• Your muscle weakness score (called a QMG score) is above 11 at the start of the study and before a blood filtering procedure.
• You have tested positive for certain antibodies linked to myasthenia gravis (AChR-Ab and/or MuSK antibody) at the screening stage.
• If you are taking steroid medication (such as prednisone), your daily dose is no more than 40mg (or an equivalent) and has been stable for at least 4 weeks before the study starts.
• You fully understand what the trial involves and are willing to sign a consent form agreeing to take part.

Who may not be able to join:

• You have a known allergy or serious reaction to the study drug SYS6020 or any of its ingredients, including an ingredient called dextran 40.
• You have a major long-term illness that is not well managed and that the study doctor feels could put you at extra risk.
• You have another autoimmune disease that requires ongoing treatment throughout your whole body (note: people with stable thyroid autoimmune disease with normal thyroid levels on a steady dose may still be eligible — confirm with trial site).
• You had a serious repeated infection recently, or you currently have an active infection that the study doctor thinks could affect your participation.
• You have a history of HIV, or you currently test positive for certain hepatitis B markers with detectable hepatitis B virus in your blood.
• You have been diagnosed with a cancer in the past 5 years, or you currently have active cancer (note: some people with certain successfully treated or low-risk tumours, including some types of thymoma, may still be eligible — confirm with trial site).
• You have a serious lung or breathing condition.
• You have a history of serious heart problems, such as significant abnormalities in heart rhythm or electrical signals in the heart.
• Your blood test results show certain liver, kidney, or clotting values that are significantly outside the normal range (confirm with trial site for specific values).
• You have alcohol dependency or a history of drug misuse, or other health conditions the study doctor considers significant.
• You currently have a mental health condition that would make it hard for you to follow the study requirements.
• You have a history of a primary immune system deficiency disease, or have had an organ or bone marrow/stem cell transplant, or are planning to have one during the trial.
• You had a significant bleeding episode in the 30 days before screening, or you need to take blood-thinning medication on an ongoing basis.
• You have previously received CAR-T cell therapy or any gene therapy.
• You received intravenous immunoglobulin (IVIG), plasma exchange, or a similar blood-filtering treatment within 1 month before the blood collection procedure for this trial.
• You have recently used certain immune-suppressing or targeted medications (such as rituximab, cyclophosphamide, calcineurin inhibitors, or eculizumab) within specific time windows before the trial begins (confirm with trial site for exact timeframes).
• The study doctor has any other reason to believe the trial is not appropriate for you.

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