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:

• People between 18 and 75 years old of any gender.
• People who are able and willing to use medically approved contraception or abstinence during the treatment period and for at least 6 months afterward; for women who could become pregnant, a negative pregnancy blood test within 7 days before joining is required, and breastfeeding must not be occurring at that time.
• People whose treating doctor estimates they are likely to survive for at least 12 weeks.
• People who are willing to take part voluntarily and sign a consent form.

For specific conditions, additional criteria apply:

• Multiple Sclerosis (MS): People with a confirmed diagnosis of progressive MS (primary or secondary) or relapsing-remitting MS under the 2017 McDonald diagnostic guidelines, with a disability score (EDSS) between 2 and 7, and — for relapsing-remitting MS — evidence of ongoing disease activity despite standard disease-modifying treatment (such as two relapses in the past two years, one relapse in the past year, or a positive specialised MRI scan in the past year).
• Neuromyelitis Optica Spectrum Disorder (NMOSD): People with a confirmed AQP4 antibody-positive diagnosis under the 2015 IPND guidelines, who have either used at least one immune-suppressing medication for over a year without adequate symptom control (or could not tolerate it), or who have had at least two relapses in the past 12 months or three relapses in the past 24 months with at least one in the past year.
• Autoimmune Encephalitis (AE): People with a clinical diagnosis under the 2016 International Diagnostic Criteria, who test positive for at least one relevant autoantibody, who have not had adequate symptom control with steroid and immune-suppressing treatments (including a CD20 monoclonal antibody), who have had an episode within the 3 months before signing the consent form, and who have a disability score meeting specific thresholds (mRS ≥ 2 or CASE ≥ 4) (confirm with trial site).
• Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): People with an antibody-positive diagnosis under the 2021 EAN/PNS guidelines, with a disability score between 2 and 9 on the INCAT scale, who have not had adequate symptom control after more than 3 months of at least one standard treatment (steroids, intravenous immunoglobulin, or plasma exchange), or who cannot tolerate those treatments.
• Myasthenia Gravis (MG): People with an antibody-positive diagnosis classified as MGFA Class II–IV under the 2020 MGFA guidelines, with a daily living impact score of 6 or more (MG-ADL), who have used at least one immune-suppressing medication for over a year without adequate control, or who require ongoing plasma exchange or intravenous immunoglobulin to manage their condition.
• MOG Antibody-Associated Disease (MOGAD): People with a clinical diagnosis under the 2023 International MOGAD criteria who test positive for MOG autoantibody on a specific type of laboratory test (cell-based assay), have a disability score (mRS) of 2 or above, and have not had adequate symptom control with steroid and immune-suppressing treatments (including a CD20 monoclonal antibody).
• Idiopathic Inflammatory Myopathies (IIM): People with a confirmed, treatment-resistant, antibody-positive diagnosis under the 2017 EULAR/ACR classification guidelines, who show signs of active disease on blood tests or imaging, test positive for specific muscle-related antibodies, and have not had adequate symptom control after at least one month of steroid treatment combined with more than 3 months of another immune-suppressing medication — or who cannot tolerate those treatments.

Who may not be able to join:

• People with a history of severe drug allergies or a strong tendency toward allergic reactions.
• People who have an active infection (fungal, bacterial, viral, or other) that is uncontrolled or requires treatment.
• People whose blood, liver, kidney, clotting, or heart function test results do not meet the minimum levels required by the trial (confirm with trial site for specific thresholds).
• People with a known history of a condition where the immune system cannot produce adequate antibodies from birth.
• People who have had an active or unresolved cancer diagnosis within the past 5 years.
• People who test positive for Hepatitis B (with detectable virus levels), Hepatitis C (with detectable virus levels), HIV, or syphilis.
• People with a confirmed history of serious psychiatric conditions, or a history of dependence on psychotropic substances that cannot be stopped.
• People who have taken part in another clinical trial within the 3 months before joining.
• People who have previously received CAR-T cell therapy.
• People who have had severe reactions to the medications cyclophosphamide or fludarabine in the past.
• People who have another autoimmune disease (separate from the condition being studied) that has caused organ damage or required immune-suppressing treatment within the past 2 years.
• People with a myasthenia gravis crisis that has not been effectively controlled in the 2 weeks before joining (relevant to MG participants).
• People who have had a stroke or a mini-stroke (transient ischaemic attack) within the 6 months before joining.
• People unwilling to use contraception from the time of consent until 6 months after treatment ends.
• People with any other medical condition that could interfere with measuring how safe or effective the treatment is.
• People who have had a blood clot in a vein or the lungs within the past 6 months and are currently receiving blood-thinning medication as a result.
• People who, in the treating doctor's judgement, are otherwise not suitable for the trial for any reason.

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