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Clinical Trials in Canada / NCT07224373
Recruiting Phase 1

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

NCT07224373 · tracked via the Priya Life Science Canada tracker
Phase
Phase 1
Started
2025-12-09
Last updated
2026-08-25

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

AZD0120 - Regimen 1AZD0120 - Regimen 2

AZD0120 - Regimen 1: Regimen 1, infusion of AZD0120

AZD0120 - Regimen 2: Regimen 2, infusion of AZD0120

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
Research Site Tucson Arizona Withdrawn
Research Site Aurora Colorado Not Yet Recruiting
Research Site Washington D.C. District of Columbia Recruiting
Research Site St Louis Missouri Recruiting
Research Site New York New York Recruiting
Research Site New York New York Recruiting
Research Site Cleveland Ohio Not Yet Recruiting
Research Site Seattle Washington Recruiting
Research Site Milwaukee Wisconsin Recruiting
Research Site Liverpool Australia Not Yet Recruiting
Research Site Melbourne Australia Recruiting
Research Site Melbourne Australia Not Yet Recruiting
Research Site Waratah Australia Not Yet Recruiting
Research Site Montreal Quebec Not Yet Recruiting
Research Site Leipzig Germany Withdrawn
Research Site Magdeburg Germany Withdrawn
Research Site Würzburg Germany Withdrawn
Research Site Cambridge United Kingdom Withdrawn
Research Site London United Kingdom Withdrawn

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07224373 on ClinicalTrials.gov ↗ ← All trials in Canada