Comparing AZD0120 - Regimen 1 with AZD0120 - Regimen 2 for multiple sclerosis

Inclusion

• +Seropositive for HIV or HTLV (including any history of HIV or HTLV).
• +Active viral (any etiology, HBV, HCV) hepatitis are excluded.
• +Diagnosis of RMS according to the 2024 McDonald Criteria (Montalban et al 2025) or diagnosis of relapsing, active SPMS according to Lublin et al 2014.
• +Participants should have an EDSS of ≤ 6.5 at screeningScreeningThe checks done before joining, to see whether a study fits.Read more →.
• +Evidence of active disease (clinical relapses and MRI activities within 2 years prior to screening), or intolerance, while on a high efficacy disease-modifying therapy for ≥ 6 months.
• +PMS CohortCohortA group of participants sharing a characteristic, followed together.Read more → Specific Inclusion CriteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more →
• +Diagnosis of PPMS according to the 2024 McDonald Criteria (Montalban et al 2025) or non-relapsing SPMS according to Lublin et al 2014.
• +Participants must have an EDSS of ≥ 3.0 and ≤ 6.5 at screening.
• +Inadequate response ≥ 1 heDMT with ≥ 6 months treatment or intolerance.
• +Exclusion CriteriaExclusion criteriaThe things that would prevent someone from taking part.Read more →
• +Participants are excluded from the study if any of the following criteria apply:
• +Any prior CAR-T or CAR-NK cell exposure.
• +Underwent splenectomy within 12 months prior to signing the ICFInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
• +Received a solid organ transplant at any time or on an active transplant waiting list.
• +Cardiac conditions or any other significant cardiac condition that would present undue risk to the participant in the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s opinion:
• +Any other central nervous system disease including epilepsy, convulsive seizures, organic encephalopathy syndrome, non-MS related paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease or associated movement disorder, psychosis, CNS vasculitis, or any other neurological disease that may impact the ability to evaluate neurotoxicity. History of a seizure disorder even if the seizure disorder is well controlled with anti-epileptics.
• +Participant has significant psychiatric condition (active or history of).
• +History of other immune-mediated disease that required continued systemic immunosuppression/systemic disease-modifying agents.
• +Evidence of clinically significant bleeding or active bleeding diathesis within 90 days before screening
• +History of malignancy or ongoing treatment for prior malignancy.
• +Inborn error of immunity and/or primary immunodeficiency.
• +Unwilling or unsafe to proceed with CSF exams based on coagulopathy or anatomy or other considerations in the judgment of the study investigator.
• +Any contraindications to LP.
• +Participants not willing, able, or are unsafe to take MRI scans as per protocolProtocolThe detailed plan a study must follow.Read more →.
• +Pregnant, breastfeeding, or planning to become pregnant while enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in this study or within 1 year after receiving study treatment, whichever is longer.
• +Prior treatment with autologous hematopoietic stem cell transplantation or total lymphoid irradiation.
• +Major surgery within 4 weeks prior to apheresis or lymphodepletion or has surgery planned during the study or within 4 weeks after study treatment administration.