Early Phase 1 Multiple Sclerosis 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:

• Blood test results at screening must show healthy enough levels of immune cells, red blood cells, platelets, and clotting proteins, with no blood transfusions or growth factor support in the 7 days before testing (confirm with trial site for exact values).
• Liver enzyme levels, bilirubin levels, kidney function, and blood oxygen levels must all fall within acceptable ranges as measured at screening.
• Heart function must be assessed by an ultrasound or scan within 8 weeks before the cell collection procedure, showing the heart is pumping adequately, with no fluid around the heart and no significant abnormalities on a heart tracing.
• People who have been formally diagnosed with multiple sclerosis (MS) according to the 2024 McDonald criteria, with their type of MS classified under the 2013 Lublin criteria as relapsing or progressive.
• People with relapsing-remitting MS (RRMS) who have tried at least one high-strength MS medication continuously for 12 months or more and whose disease has remained active, shown by recent relapses or new areas of inflammation visible on brain MRI scans.
• People with primary progressive MS (PPMS) who have tried a high-strength MS medication and whose condition has continued to worsen within the past year, with no active inflammatory spots visible on their brain MRI at screening.
• People with secondary progressive MS (SPMS) who have tried a high-strength MS medication and whose condition has continued to worsen within the past year, with no active inflammatory spots visible on their brain MRI at screening.
• People whose MS-related disability level falls within a specific range on the standard disability scale (EDSS score of 2.0 to 6.5) (confirm with trial site).
• People who have a documented history, or confirmation at screening, of certain markers of MS-related immune activity in their spinal fluid (oligoclonal bands, elevated IgG index, or elevated KFLC index).

Who may not be able to join:

• People who have an active, uncontrolled infection, or who needed hospital care or intravenous antibiotics for an infection within the 4 weeks before screening (minor urinary tract infections or throat infections that are responding to treatment may be acceptable).
• People with active tuberculosis, or latent (inactive) tuberculosis that has not been properly treated before screening.
• People with a history of severe allergic reactions.
• People with a condition where the immune system does not work properly from birth (primary immunodeficiency).
• People with significant heart problems or reduced heart function.
• People with a serious breathing condition, including moderate-to-severe asthma, chronic obstructive pulmonary disease, scarring of the lungs, or similar lung diseases.
• People who have had cirrhosis (scarring of the liver), currently or in the past.
• People with a history of Crohn's disease, rheumatoid arthritis, or lupus within the past 2 years who have needed ongoing immune-suppressing or disease-modifying medications.
• People with an active cancer, or a history of most cancers within the past 5 years. Some very early-stage or fully treated skin, thyroid, cervical, or breast cancers may be exceptions (confirm with trial site).
• People who have had significant bleeding problems or a known bleeding disorder in the 6 months before screening.
• People who have experienced a stroke, brain bleed, deep vein blood clot, or pulmonary blood clot within the 6 months before screening.
• People with certain blood disorders, including a history of myelodysplastic syndrome, sickle-cell anaemia, or similar conditions affecting red blood cells.
• People with significant signs of dementia or major changes in mental functioning.
• People with a history of other brain or nervous system conditions such as epilepsy, seizures, paralysis, stroke, severe brain injury, Parkinson's disease, or psychosis.
• People with mental health or psychological conditions that, in the opinion of the trial team, would place them at unacceptable risk.
• People who test positive for HIV, active hepatitis B, active hepatitis C, human T-cell lymphotropic virus (types I or II), or syphilis.
• People who have received a live vaccine within 4 weeks before the cell collection procedure.
• People who have taken part in another clinical drug trial within 4 weeks before the cell collection procedure, or within a timeframe based on how long the previous trial drug stays in the body (whichever is longer).
• People who have had their spleen removed within the 12 months before signing the trial consent form.
• People who have previously received any CAR T-cell therapy, or any treatment targeting specific immune proteins called CD19 or BCMA.
• People who received certain B-cell targeting medications (such as rituximab, ofatumumab, or ocrelizumab) within 4 weeks before the cell collection procedure.
• People who took siponimod or ozanimod within 1 month before the cell collection procedure.
• People who took fingolimod within 6 weeks before the cell collection procedure.
• People who took teriflunomide within 3 months before the cell collection procedure.
• People who took dimethyl fumarate within 2 weeks before the cell collection procedure.
• People who have had major surgery within 8 weeks before signing the consent form, or who have surgery planned during the study period (minor surgery under local anaesthetic may be acceptable if not within 2 weeks of the treatment infusion).
• People who have previously had an organ transplant.
• People who have a diagnosis of neuromyelitis optica spectrum disorder, myelin oligodendrocyte glycoprotein (MOG) antibody-related disease, or another neurological condition that may be confused with MS.
• People with a history of tumours in the brain or spinal cord, certain spinal cord conditions, inherited progressive brain diseases, sarcoidosis, or other progressive neurological diseases unrelated to MS.
• People with other brain conditions, such as blood vessel disease, dementia, or unrelated spinal or brain disorders, that could make it harder to assess safety during the trial.
• People with a history of seizures, even if seizures have been well controlled with medication.
• People with particularly large MS lesions in the brain (3 cm or more within the past 5 years), reduced levels of consciousness, or other active brain changes that could complicate safety monitoring.
• People for whom a lumbar puncture (spinal tap) is not safe, including those with certain spinal abnormalities, bleeding risks, or who are taking blood-thinning medications that cannot be safely paused (low-dose aspirin of 100 mg/day or less may be acceptable).
• People who are unable or unwilling to have MRI scans as required by the trial, including those with claustrophobia or with metal implants, pacemakers, or similar devices that are not compatible with MRI.
• People for whom the trial team considers participation to not be in their best interest, or whose circumstances could interfere with the study.
• People who, based on a specific suicidality assessment tool (C-SSRS), are currently experiencing active thoughts of suicide with intent or a specific plan, or who have a recent history of suicidal behaviour.

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