RecruitingPhase 1NCT07224373

An Open-label Study of AZD0120 in 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


Sponsor

AstraZeneca

Enrollment

24 participants

Start Date

Dec 9, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called AZD0120 for adults with multiple sclerosis (MS). It is being evaluated both in people with relapsing forms of MS (whose disease has flare-ups) and progressive forms of MS (where disability steadily worsens). The drug aims to protect the nervous system and reduce disease activity. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with relapsing MS (including active secondary progressive MS) according to 2017 diagnostic criteria — with evidence of recent disease activity and either poor tolerance of or inadequate response to a high-efficacy MS treatment - OR you have been diagnosed with primary progressive MS or non-active secondary progressive MS, with disability between EDSS 3.0 and 6.5, and have not responded well to at least one high-efficacy therapy - Your overall health is adequate based on screening tests **You may NOT be eligible if...** - You have not tried any high-efficacy disease-modifying therapy previously (in most cases) - You have significant liver, kidney, or immune problems - You have an active infection or significant uncontrolled medical condition - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAZD0120 - Regimen 1

Regimen 1, infusion of AZD0120

BIOLOGICALAZD0120 - Regimen 2

Regimen 2, infusion of AZD0120


Locations(19)

Research Site

Tucson, Arizona, United States

Research Site

Aurora, Colorado, United States

Research Site

Washington D.C., District of Columbia, United States

Research Site

St Louis, Missouri, United States

Research Site

New York, New York, United States

Research Site

New York, New York, United States

Research Site

Cleveland, Ohio, United States

Research Site

Seattle, Washington, United States

Research Site

Milwaukee, Wisconsin, United States

Research Site

Liverpool, Australia

Research Site

Melbourne, 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

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07224373


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