Phase 2 Multiple Sclerosis 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 have read and signed a consent form agreeing to take part in the trial.
• People aged 18 or older at the time of screening.
• People who have been diagnosed with multiple sclerosis (MS) meeting specific diagnostic guidelines known as the 2017 McDonald criteria.
• People whose MS is progressing or getting worse, as defined by specific MS classification guidelines from 2014.
• People with relapsing or secondary progressive MS (RRMS/SPMS) whose disease has continued to be active — such as having relapses, worsening disability scores, or new areas of damage visible on MRI — despite having been on certain strong MS treatments for at least 6 months.
• People with primary progressive MS (PPMS) whose disease has continued to worsen or show new MRI activity despite treatment with a specific medication called ocrelizumab for at least 6 months.
• People with PPMS or SPMS who have a specific marker of immune activity in their spinal fluid, called oligoclonal bands (confirm with trial site).
• People who are fully vaccinated against Hepatitis B.
• People who either have evidence of past chickenpox/shingles infection through blood tests, or who have received at least one dose of the Shingrix shingles vaccine at least 4 weeks before treatment.
• People who have blood test evidence of past Epstein-Barr virus (EBV) infection.
• People whose blood test results show healthy levels of immune cells, platelets, and proteins within the ranges required by the trial.
• People whose kidneys, liver, lungs, and heart are functioning adequately, as confirmed by specific tests and measurements outlined in the trial requirements.
• People who test negative for Hepatitis B, Hepatitis C, CMV, chickenpox/shingles virus, and herpes simplex viruses 1 and 2.
• People who test negative for two specific antibodies — MOG and AQP-4 — that are associated with conditions other than MS.
• Women who could become pregnant must be willing and able to use at least one highly effective form of contraception from the time of signing consent until 12 months after receiving the trial treatment, and must not donate eggs during that period.
• Men whose partners could become pregnant must be willing and able to use at least one highly effective form of contraception from the time of signing consent until 12 months after receiving the trial treatment.
• People who are willing and able to follow all trial procedures throughout the study.
• People with stable and adequate vital signs (such as heart rate and blood pressure) at the time of screening.

Who may not be able to join:

• People with a disability score above 7.0 on the standard MS scale (EDSS), or people older than 55 years; additionally, for progressive MS only, people whose MS has been present for more than 15 years.
• People with a history of cancer, unless they have been cancer-free for 5 or more years — with the exception of certain minor skin cancers.
• People with a known history of active Hepatitis B infection.
• People with a known history of Hepatitis C infection, unless it has been successfully treated and confirmed clear by a specific blood test.
• People with any active, uncontrolled infection — whether bacterial, viral, or fungal.
• People with a history of HIV infection.
• People with a history of active or latent tuberculosis (TB); however, re-screening may be possible after completing a full course of TB treatment (confirm with trial site).
• People with a history of a condition called neuromyelitis optica spectrum disorder (NMOSD) or a related condition caused by MOG antibodies.
• People with a history of certain other neurological conditions affecting the brain or spinal cord that are not MS, including tumours, inherited disorders, sarcoidosis, or other progressive conditions that could affect the ability to complete trial assessments.
• People with a history of certain bone marrow or blood cell conditions, including myelodysplastic syndrome (MDS).
• People with a history of sickle cell anaemia or other inherited blood disorders affecting haemoglobin.
• People with a primary immune deficiency disease.
• People who test positive for certain antibodies linked to blood clotting disorders, including antiphospholipid antibodies, anti-cardiolipin, or lupus anticoagulant.
• People with moderate or severe kidney impairment, as defined by specific kidney function measurements.
• People with ongoing inflammatory conditions of the digestive tract, such as inflammatory bowel disease or peptic ulcers, that could increase the risk of serious complications.
• People with certain heart conditions, including advanced heart failure (New York Heart Association Stage III or IV), a heart attack or bypass surgery within the past 6 months, or a history of serious irregular heart rhythms or unexplained fainting.
• People with a history of severe non-ischemic cardiomyopathy (a type of heart muscle disease).
• People who have recently taken certain medications, including high-dose steroids within 7 days, certain immune-suppressing drugs within 21 days, previous CAR T cell therapy, live vaccines within 30 days, or other specific MS treatments — all measured before a procedure called leukapheresis (a process to collect immune cells).
• People with a known allergy or serious sensitivity to any medication likely to be used during the trial.
• People with any other medical reason that the trial doctor believes makes the trial procedures unsuitable for them.
• People who are pregnant or breastfeeding, or women who could become pregnant and are not willing to use effective contraception from leukapheresis through to 12 months after receiving the trial treatment.
• People currently taking part in another interventional clinical trial.
• People who are unable to understand the procedures and risks involved in the trial.
• People with any additional reason identified by the trial doctor that would make participation unsuitable.

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