Phase 1 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:

• Adults between 18 and 80 years old (people aged 75 or older would need an additional geriatric health assessment before being considered)
• People diagnosed with Systemic Lupus Erythematosus (SLE) whose disease is severe and active, and whose condition has not responded well enough to multiple previous treatments including standard immune-suppressing medicines, a calcineurin inhibitor, and a biologic therapy — or who were unable to take those treatments due to side effects or medical reasons
• People diagnosed with Systemic Sclerosis (SSc, also called scleroderma), either the diffuse or limited form, with severe or rapidly worsening disease, whose condition has not responded to at least two standard immune-suppressing therapies — or who could not take them due to side effects or medical reasons
• People diagnosed with Inflammatory Muscle Disease (IIM), including dermatomyositis, anti-synthetase syndrome, immune-mediated necrotising myopathy, or polymyositis, with ongoing active disease signs, whose condition has not responded to at least two standard immune-suppressing therapies and either rituximab or IVIG — or who could not take them due to side effects or medical reasons
• People diagnosed with seropositive Rheumatoid Arthritis (RA) — meaning blood tests are positive for specific markers — with highly active disease that has not responded to at least four groups of standard treatments, including JAK inhibitors, anti-TNF agents, anti-IL6 drugs, and anti-CTLA4 treatments — or who could not take them due to side effects or medical reasons
• People diagnosed with AQP4-antibody-positive Neuromyelitis Optica Spectrum Disorder (NMOSD) who have had at least two relapses in the past two years (with at least one in the past year), and whose disease was not adequately controlled by standard immunosuppressants, rituximab, or targeted therapies — or who could not take them
• People with confirmed Primary Progressive or Secondary Progressive Multiple Sclerosis (MS), with a disability score between 3.0 and 8.5, whose disease has continued to worsen despite at least one high-efficacy treatment for at least six months, and who have previously been treated with an anti-CD20 antibody medicine with ongoing documented worsening disability
• People with confirmed generalised Myasthenia Gravis (MG) with positive antibodies (anti-AChR or anti-MuSK), significant symptoms affecting daily life, and disease that has not responded adequately to immune-suppressing or immune-modulating therapies — or who meet specific criteria for refractory disease as assessed by the trial site
• People with confirmed Antiphospholipid Antibody Syndrome (APLA) with medium to high antibody levels on repeated testing, whose disease has continued despite stable anticoagulation therapy and immune-suppressing treatments including rituximab
• People whose liver enzyme levels are within an acceptable range (below five times the upper limit of normal for AST/ALT, and below three times the upper limit of normal for bilirubin)
• People whose heart and lung function is broadly within acceptable limits, including a heart pumping function (ejection fraction) above 45%, no more than mild pulmonary high blood pressure, and blood oxygen levels above 93% at rest without supplemental oxygen
• People with no clear signs of active infection at the time of joining
• People who are able to have blood collected without medical contraindication
• Women who could become pregnant must have a negative pregnancy blood test before treatment begins, and all participants who are sexually active must agree to use effective contraception throughout the study
• People who are willing and able to give informed consent, either personally or through a legal representative, and who are able to follow the study schedule and requirements

Who may not be able to join:

• People with certain brain or spinal cord conditions unrelated to the autoimmune disease being studied, such as tumours, inherited neurological disorders, sarcoidosis, progressive non-autoimmune neurological conditions, or a history of a brain infection called PML
• People with significantly abnormal liver function test results (unless the abnormality is caused by inflammatory muscle disease, which the trial site would assess separately)
• People who have had a heart attack, unstable chest pain, or heart bypass surgery within the past six months, or who have had serious heart rhythm problems, significant pulmonary high blood pressure, or whose heart pumping function is below 45%
• People with serious lung disease, including blood oxygen levels below 90% at rest, severely reduced lung capacity on breathing tests, or significant pulmonary high blood pressure on assessment
• People with evidence of severe muscle wasting in the arms or legs, or with a muscle condition other than the one being treated — such as inclusion body myositis, or muscle disease associated with cancer diagnosed within the past two years
• People with other serious unstable or uncontrolled medical conditions unrelated to their autoimmune disease, which the investigating doctor considers could affect safety or study results
• People who have received rituximab within four months before the planned treatment, or who have had plasma exchange or immunoglobulin treatment within four weeks before the screening visit; MS patients must not have received high-dose steroid treatment in the 30 days before joining (confirm additional restrictions with the trial site)
• People who have taken part in another clinical trial within the past three months, or who would be participating in another trial at the same time
• People with a current or previous cancer diagnosis, with limited exceptions for certain fully treated skin cancers or cancers in complete remission for at least three to five years (confirm with trial site)
• People who have had a transplant of a vital organ (such as heart, lung, kidney, or liver) or a bone marrow or stem cell transplant
• MS or NMOSD patients who have had a disease relapse within the 30 days before joining
• People who are known to be HIV positive
• People with active hepatitis B or C infection
• People with active CMV (cytomegalovirus) infection
• Women who are pregnant or breastfeeding
• People who are unable to understand or follow the study requirements
• People with any other significant medical condition that the treating doctor considers may affect their safety or the study's results

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