Phase 2 Transverse Myelitis 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 have a neuroimmune disease that has not responded well to treatment — specifically, it has not been controlled despite trying at least three different immune-suppressing medications for more than one year, OR you have had at least two relapses (flare-ups) in the past 12 months, or at least three relapses in the past 24 months with at least one in the past 12 months.
• If you are male, you must agree to use contraception during treatment and for one year afterward, and agree not to donate sperm during the study.
• If you are a woman who could become pregnant, you must agree to use contraception during treatment and for at least one year afterward, and have negative pregnancy test results before starting treatment.

Who may not be able to join:

• You have a medical or mental health condition that the study doctor believes could put you at risk or prevent you from fully participating.
• You have had a problem with drug or alcohol misuse in the past 12 months, or the doctor has concerns about your ability to follow the study plan.
• You are currently pregnant, breastfeeding, planning to become pregnant within 12 months after treatment, or have had a pregnancy loss within the 4 weeks before screening.
• You have had a significant active infection (such as blood poisoning, pneumonia, or an abscess) or a serious infection requiring hospitalisation or antibiotics within the past 4 weeks.
• You have received a live vaccine within 8 weeks before starting the study, or are scheduled to receive one (including a COVID-19 vaccine) within 8 weeks after treatment.
• You have received the medication rituximab within the past 6 months.
• You have received the medications tocilizumab or eculizumab within the past 3 months.
• You have received intravenous immunoglobulin, plasma exchange, or certain immunotherapy treatments within the past 4 weeks.
• You have serious ongoing health conditions such as significant liver or kidney problems, blood disorders, severe heart disease, severe high blood pressure, or poorly controlled diabetes.
• You have a diagnosed mental illness or have had thoughts of suicide (including a suicide attempt) in the past 6 months, as assessed using a standard scale (confirm with trial site).
• Your blood test results during screening show certain abnormalities, such as high liver enzyme levels, high bilirubin, reduced kidney function, or a low level of certain immune cells called CD19+ B cells (confirm with trial site for exact values).
• You have a history of tuberculosis or are considered at high risk of getting tuberculosis.
• You have a known immune deficiency condition, including HIV infection.
• You tested positive for the hepatitis B surface antigen during screening.
• You have received a blood transfusion in the 4 weeks before the start of the study or during the screening period.
• The study doctor considers you unsuitable for any other reason.

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