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 are willing to sign a consent form (either themselves or through a legal guardian)
• People aged 18 to 70 years old at the time of signing the consent form, of any gender
• People whose blood tests at screening show certain markers on their B cells (CD19 positive) and T cells (CD7 positive)
• People who have been formally diagnosed with one of the following conditions: Systemic Lupus Erythematosus (SLE), Myasthenia Gravis (MG), or Systemic Sclerosis (SSc, also called scleroderma), based on recognised medical diagnostic standards
• People who have had their autoimmune condition for at least 6 months before screening, and whose disease remains active despite standard treatments — the specific requirements differ depending on the condition (confirm with trial site)
• People whose steroid medication (such as prednisone) has been taken for more than 6 weeks before screening and has been at a stable, low dose for at least 14 days before the study treatment
• People taking certain antimalarial drugs (such as hydroxychloroquine or chloroquine) who have been on a stable dose for at least 8 weeks and started the medication at least 12 weeks before screening
• People with SLE whose blood tests show certain immune markers (ANA positive, and/or anti-dsDNA or anti-Smith antibodies positive)
• People with MG whose blood tests show certain immune markers related to the condition (anti-AChR or anti-MuSK antibodies positive)
• People with a life expectancy of more than 6 months
• People whose bone marrow, heart, lung, liver, kidney, and blood clotting functions meet certain minimum levels as measured by standard tests (confirm with trial site for specific values)
• Women of childbearing potential who test negative for pregnancy at screening and agree to use highly effective contraception during the study and for 12 months after the last dose
• Men whose partners could become pregnant and who agree to use highly effective contraception during the study and for 12 months after the last dose

Who may not be able to join:

• People who have another autoimmune disease that requires ongoing whole-body (systemic) treatment
• People with SLE who are experiencing a kidney crisis; people with MG who are in the most severe category (MGFA type V) or are experiencing a myasthenic crisis; people with SSc who have severe lung disease or severe lung blood pressure problems, or are experiencing a kidney crisis related to scleroderma
• People who test positive for Hepatitis B, Hepatitis C, HIV, CMV (a type of virus), or syphilis
• People who have another active infection that is not under control at the time of screening
• People whose kidney function falls below a certain level (as measured by specific kidney function tests — confirm with trial site)
• People who have previously had a major organ transplant (such as heart, lung, liver, or kidney) or a bone marrow or stem cell transplant
• People who have had serious heart problems in the 6 months before screening, such as severe heart failure, a heart attack, unstable chest pain, or certain heart rhythm problems
• People who have had significant bleeding in the 4 weeks before screening, or who need to take long-term blood-thinning medication
• People who have had a serious active brain or nervous system condition in the past 6 months, such as a stroke, seizures, severe brain injury, or dementia (people with stable conditions may be assessed individually by the trial doctor)
• People who have been diagnosed with a cancer in the past 5 years (some early-stage or fully treated skin, cervical, prostate, or breast conditions may be exceptions — confirm with trial site)
• People who have received a live vaccine in the past 4 weeks
• People who have recently received certain treatments, including plasma exchange or dialysis within 14 days before screening, another clinical trial drug within 4 weeks before screening, any previous bone marrow transplant, gene therapy, or CAR-T cell therapy, or any previous treatment using mRNA-LNP or similar technology
• People who are unable to complete the required washout period from previous medications, or unable to keep their autoimmune disease medications at a stable dose
• People who are pregnant or breastfeeding
• People who are allergic to medications commonly used to manage side effects of CAR-T cell therapy (such as tocilizumab)
• People who the trial doctor believes may be unwilling or unable to follow the study requirements

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