An Open-label Study of AZD0120 in Adults With Multiple Sclerosis

Recruiting now · Phase 1

Conditions studied: Multiple Sclerosis

In brief

This trial is a Phase 1b, open-label, multi-center, clinical study of AZD0120, a BCMA/CD19 dual targeting CAR+ T-cell therapy, to evaluate the safety and tolerability in adult participants with Multiple Sclerosis.

Key facts

Study ID

NCT07224373

Run by

AstraZeneca

People needed

24

Starts

2025-12-09

Expected to finish

2028-12-12

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• 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 ICF.
• Received a solid organ transplant at any time or on an active transplant waiting list.
• Prior treatment with autologous hematopoietic stem cell transplantation or total lymphoid irradiation.
• Cardiac conditions or any other significant cardiac condition that would present undue risk to the participant in the investigator'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.
• Seropositive for HIV or HTLV (including any history of HIV or HTLV).
• Active viral (any etiology, HBV, HCV) hepatitis are excluded.
• 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.
• Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 1 year after receiving study treatment, whichever is longer.
• 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 protocol.

Where it is running

• Research Site — New York, New York, United States (enrolling)
• Research Site — Melbourne, Australia (enrolling)
• Research Site — St Louis, Missouri, United States (enrolling)
• Research Site — Seattle, Washington, United States (enrolling)
• Research Site — New York, New York, United States (enrolling)
• Research Site — Liverpool, Australia
• Research Site — Melbourne, Australia
• Research Site — Waratah, Australia
• Research Site — Montreal, Quebec, Canada
• Research Site — Leipzig, Germany
• Research Site — Magdeburg, Germany
• Research Site — Würzburg, Germany
• Research Site — Cambridge, United Kingdom
• Research Site — Tucson, Arizona, United States
• Research Site — London, United Kingdom
• Research Site — Aurora, Colorado, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Cleveland, Ohio, United States
• Research Site — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.