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AZD0120 CAR T-cell therapy for adults with multiple sclerosis

A Phase 1b, Open-label, Multi-center, Randomized Study Evaluating the Safety and Tolerability of AZD0120, an Autologous CD19/BCMA Targeting Chimeric Antigen Receptor T-cells, in Adults With Refractory Relapsing or Progressive Multiple Sclerosis

Phase 1 Interventional AstraZeneca · NCT07224373

This trial will test whether AZD0120, a BCMA/CD19 dual-targeting CAR T-cell therapy, is safe and tolerable in adults with relapsing or progressive multiple sclerosis.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment24 (estimated)
Ages18 Years to 60 Years
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsCAR-T
Locations19 sites (Tucson, Arizona and 18 other locations)
Trial IDNCT07224373 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–60 with relapsing MS (including active SPMS) or progressive MS (PPMS or non-relapsing SPMS) who have recent disease activity or intolerance to high-efficacy therapy and adequate organ function are the intended candidates.

Not a fit: People outside the 18–60 age range, with advanced disability, significant comorbidities, inadequate physiologic reserve, or without recent disease activity are unlikely to benefit from this early-phase safety-focused trial.

Why it matters

Potential benefit: If safe and effective, this approach could provide a new immune-cell therapy option that reduces relapses or slows progression for some people with MS.

How similar studies have performed: Cellular immunotherapies have shown promising early results in small autoimmune disease trials, but BCMA/CD19 dual-targeting CAR T-cell therapy in MS is largely novel and unproven in larger studies.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Tucson, Arizona and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple SclerosisAZD0120MSRMSPMS
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.