Recruiting

ZENITHAZD0120 CAR T-cells for Refractory Multiple Sclerosis

Study Aim

This phase 1 study aims to evaluate the safety and tolerability of AZD0120 CAR T-cells in people with refractory multiple sclerosis over 104 weeks.

What is being tested

AZD0120 - Regimen 1

+ AZD0120 - Regimen 2

Biological

Who is being recruted

Autoimmune Diseases+4

+ Demyelinating Diseases

+ Immune System Diseases

From 18 to 75 Years

+27 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 1

Interventional

Study Start: December 2025

See protocol details

Summary

Principal SponsorAstraZeneca

Study ContactAstraZeneca Clinical Study Information Center

Last updated: February 3, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 9, 2025

Actual date on which the first participant was enrolled.

This clinical trial is focused on testing the safety and tolerability of a new treatment called AZD0120 for adults who have a form of multiple sclerosis (MS) that is either relapsing or progressing despite previous treatments. The study aims to find out if this treatment can be safely administered without harmful side effects. AZD0120 is a type of therapy that uses modified cells from the patient to target specific proteins related to their condition. This trial is important because it could lead to new treatment options for people with MS who have not responded well to existing therapies. Participants in the study will receive AZD0120, which involves using their own cells that are engineered to attack the disease. Researchers will monitor participants for up to 104 weeks, checking for any possible side effects or reactions to the treatment. The study will focus on identifying any adverse events, serious adverse events, and any dose limitations to ensure the safety of the treatment. By assessing these factors, the study aims to determine the appropriate dosage for future research phases, potentially paving the way for new advancements in MS treatment.

Official TitleA 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

NCT07224373

Principal SponsorAstraZeneca

Study ContactAstraZeneca Clinical Study Information Center

Last updated: February 3, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

24 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesDemyelinating DiseasesImmune System DiseasesMultiple SclerosisNervous System DiseasesAutoimmune Diseases of the Nervous SystemDemyelinating Autoimmune Diseases, CNS

Criteria

9 inclusion criteria required to participate

Diagnosis of RMS according to the 2017 McDonald Criteria (Thompson et al 2018) or diagnosis of relapsing, active SPMS according to Lublin et al 2014

Participants should have an EDSS of ≤ 6.5 at screening

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

Diagnosis of PPMS according to the 2017 McDonald Criteria (Thompson et al 2018) and/or diagnosis of not active progressive SPMS according to Lublin et al 2014

Show More Criteria

18 exclusion criteria prevent from participating

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

Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 1 year after receiving study treatment, whichever is longer

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

Participants not willing, able, or are unsafe to take MRI scans as per protocol

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

AZD0120 RMS

Group II

Experimental

AZD0120 PMS

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 13 locations

Recruiting

Research Site

St Louis, United StatesOpen Research Site in Google Maps

Recruiting

Research Site

New York, United States

Recruiting soon

Research Site

Tucson, United States

Recruiting soon

Research Site

Aurora, United States

Recruiting

13 Study Centers