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 80 years old
• You are willing and able to follow the study plan, complete all required assessments, and attend follow-up visits
• You have been diagnosed with myasthenia gravis (MG) with typical symptoms, and your blood tests have shown positive MG-related antibodies (AChR-Ab, MuSK-Ab, or LRP4)
• Your MG has been considered "refractory" (hard to treat) by the study doctor, meaning at least two immunosuppressant medications have not worked well enough, or your condition keeps getting worse, or you cannot tolerate the side effects of current treatments
• You regularly need plasma exchange or intravenous immunoglobulin (IV infusions) to keep your symptoms under control
• Your MG severity falls within a specific middle range (called MGFA class IIa–IVa) at the time of screening and at the start of the study (confirm with trial site)
• Your MG symptom scores are above a certain level on standard rating scales at both screening and the start of the study (confirm with trial site)
• If you are male, you agree to use contraception during treatment and for at least 1 year afterward, and you agree not to donate sperm during the study
• If you are a woman who could become pregnant, you agree to use contraception during treatment and for at least 1 year afterward, and you have a negative pregnancy test at screening and before starting treatment

Who may not be able to join:

• You have a medical or mental health condition that the study doctor believes could be harmful or make it difficult for you to participate
• You are currently pregnant, breastfeeding, planning to become pregnant within 12 months of starting treatment, or have had a miscarriage or abortion in the 4 weeks before screening
• You have had a serious active infection (such as blood poisoning, pneumonia, or an abscess) or an infection serious enough to require hospitalisation or antibiotics in the 4 weeks before screening
• You have had surgery to remove a thymoma (a type of tumour near the heart) within the past 6 months, are planning such surgery during the study, or need chemotherapy or radiotherapy at any point
• You have received a live vaccine (such as certain flu, MMR, or shingles vaccines) within the 8 weeks before screening, or plan to receive one within 8 weeks after treatment
• You have been treated with rituximab (an immune-suppressing medication) in the 6 months before screening
• You have been treated with tocilizumab or eculizumab (immune-related medications) in the 3 months before screening
• You have received intravenous immunoglobulin, plasma exchange, or certain immunotherapy treatments in the 4 weeks before screening
• You have serious known health conditions such as significant liver or kidney problems, blood disorders, severe heart disease, severely uncontrolled high blood pressure, or poorly controlled diabetes
• You have a thymoma that has not been surgically removed (note: people who had a non-spreading thymoma removed more than one year ago may still be eligible — confirm with trial site)
• Your blood tests during screening show abnormal results for liver function, kidney function, blood clotting, red or white blood cell counts, or platelets (confirm specific values with trial site)
• You have a history of tuberculosis infection or are known to have an active tuberculosis infection
• You have a known immune deficiency condition, including HIV infection
• Your hepatitis B surface antigen test is positive at screening
• You have received a blood transfusion in the 4 weeks before or during the screening period
• Your MG symptoms worsen significantly during the lead-in period and reach a crisis or near-crisis level (MGFA class IVb–V)
• The study doctor has any other reason to consider your participation inappropriate

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