AZD0120 CAR T-cell therapy for adults with multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

AZD0120 is a BCMA/CD19 dual-targeting CAR+ T-cell therapy being given to adults with relapsing or progressive forms of multiple sclerosis in an open-label, multicenter Phase 1b protocol. Participants receive one of two AZD0120 regimens and are monitored closely for dose-limiting toxicities and treatment-emergent adverse events, with safety reviews by a safety review committee to determine the recommended Phase 2 dose for each cohort. Approximately 9–12 participants will be enrolled per disease cohort across three U.S. sites, and procedures include leukapheresis, cell manufacture, infusion, and scheduled follow-up visits. Enrollment is limited to adults 18–60 with adequate physiological reserve and cohort-specific disease activity or progression criteria.

Why it matters

Who can join: the full rules

Participants are eligible to be included in the study only if all of the following criteria apply:

Age

1. Age ≥ 18-years-old to ≤ 60-years-old at the time of consent

   Type of Participant and Disease Characteristics
2. Written informed consent in accordance with federal, local, and institutional guidelines
3. Adequate physiological function and reserve at screening

   RMS Cohort Specific Inclusion Criteria
4. 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.
5. Participants should have an EDSS of ≤ 6.5 at screening.
6. 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 Cohort Specific Inclusion Criteria
7. Diagnosis of PPMS according to the 2024 McDonald Criteria (Montalban et al 2025) or non-relapsing SPMS according to Lublin et al 2014.
8. Participants must have an EDSS of ≥ 3.0 and ≤ 6.5 at screening.
9. Inadequate response ≥ 1 heDMT with ≥ 6 months treatment or intolerance.

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

1. Any prior CAR-T or CAR-NK cell exposure.
2. Underwent splenectomy within 12 months prior to signing the ICF.
3. Received a solid organ transplant at any time or on an active transplant waiting list.
4. Prior treatment with autologous hematopoietic stem cell transplantation or total lymphoid irradiation.
5. Cardiac conditions or any other significant cardiac condition that would present undue risk to the participant in the investigator's opinion:
6. 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.
7. Participant has significant psychiatric condition (active or history of).
8. History of other immune-mediated disease that required continued systemic immunosuppression/systemic disease-modifying agents.
9. Evidence of clinically significant bleeding or active bleeding diathesis within 90 days before screening
10. History of malignancy or ongoing treatment for prior malignancy.
11. Inborn error of immunity and/or primary immunodeficiency.
12. Seropositive for HIV or HTLV (including any history of HIV or HTLV).
13. Active viral (any etiology, HBV, HCV) hepatitis are excluded.
14. 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.
15. Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 1 year after receiving study treatment, whichever is longer.
16. Unwilling or unsafe to proceed with CSF exams based on coagulopathy or anatomy or other considerations in the judgment of the study investigator.
17. Any contraindications to LP.
18. Participants not willing, able, or are unsafe to take MRI scans as per protocol.

Where it's running

• Research Site
  Washington D.C., District of Columbia, United States Recruiting
• Research Site
  St Louis, Missouri, United States Recruiting
• Research Site
  New York, New York, United States Recruiting
• Research Site
  New York, New York, United States Recruiting
• Research Site
  Seattle, Washington, United States Recruiting
• Research Site
  Milwaukee, Wisconsin, United States Recruiting

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.