Phase 2 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:

• People who have been diagnosed with multiple sclerosis (MS), specifically the progressive forms known as primary progressive MS (PPMS) or secondary progressive MS (SPMS), based on 2025 diagnostic guidelines.
• People whose MS-related disability falls within a specific range on a standard disability measurement scale (confirm with trial site for exact score range).
• People who have shown signs of their disability getting worse in the two years before joining the trial.
• People whose spinal fluid (CSF) or blood tests show certain markers of immune activity linked to MS.
• People aged 18 to 65 years old at the time of signing consent.
• People whose heart, kidneys, liver, and other organs are functioning adequately.
• Women who could become pregnant must have a negative pregnancy test at the screening visit.
• All participants must agree to use contraception for the duration of the study.
• People who are able to understand the study, give their consent, and attend all required visits and procedures.
• People who have immunity to chickenpox (varicella zoster virus) — those who do not have this immunity may need to receive a vaccination at least four weeks before receiving the study treatment.
• People who are willing to not donate blood for one year after receiving the study treatment.

Who may not be able to join:

• People whose MS has been stable on their current MS medication.
• People who have had an MS relapse (flare-up) in the year before joining the study.
• People whose symptoms may be caused by a condition other than MS, including certain antibody-related conditions (such as positive AQP4-IgG or MOG-IgG).
• People who have previously received CAR-T cell therapy or any gene therapy.
• People who have been treated with certain strong MS medications — including mitoxantrone, cladribine, or alemtuzumab — within the two years before receiving the study treatment.
• People who have received certain other MS medications (CD20-depleting antibodies, BTK inhibitors, or S1P modulators) too recently before the study treatment (timeframes vary by medication — confirm with trial site).
• People who have received a live vaccine within four weeks, or any other vaccine within two weeks, before receiving the study treatment.
• People with an active hepatitis B or hepatitis C infection based on blood tests.
• People who test positive for HIV.
• People with a history of a serious brain infection called progressive multifocal leukoencephalopathy (PML).
• People with active or untreated tuberculosis, or latent tuberculosis without a clear chest X-ray confirming no active disease.
• People with a known genetic disorder that causes a primary immune deficiency.
• People who have had their spleen removed.
• People with significant heart problems or impaired heart function.
• People with a current or past cancer diagnosis.
• People who have had an organ transplant, a stem cell transplant from a donor, or received certain blood products within three years before the study treatment.
• People who have had major surgery within four weeks before, or who have major surgery planned within four weeks after, receiving the study treatment.
• People with another neurological condition or serious medical condition that the study doctor believes would increase risk, including epilepsy or seizure disorders.
• People with known severe allergies or intolerance to the ingredients in the study treatment.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study period.
• People with a serious or uncontrolled medical condition that the study doctor believes could make participation unsafe or interfere with the study.

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