Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsPhase1

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

Sponsor: AstraZeneca

NCT ID: NCT07224373

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
AZD0120 - Regimen 1 (biological), AZD0120 - Regimen 2 (biological)
How long the study runs
Study runs about 36 months (dates as stated)
About the drug or intervention
AZD0120 - Regimen 1 — biological: Regimen 1, infusion of AZD0120 · AZD0120 - Regimen 2 — biological: Regimen 2, infusion of AZD0120
Patient visit burden
Not specified by the sponsor

In plain English

This is an open-label study (everyone knows what treatment they are getting) testing a medicine called AZD0120 in adults aged 18 to 60 with multiple sclerosis (MS), a condition where the immune system affects the nerves. It includes people with relapsing MS (relapsing-remitting MS or active secondary progressive MS) and people with progressive MS (primary progressive MS or non-relapsing secondary progressive MS). The study is sponsored by AstraZeneca.

Who can take part

  • Aged 18 to 60 when agreeing to take part
  • Able to give written informed consent
  • Generally healthy body function at screening
  • For the relapsing MS group: a diagnosis of relapsing MS (including active secondary progressive MS), a disability score (EDSS) of 6.5 or less, and either signs of active disease (relapses or changes on MRI scans within the past 2 years) or intolerance to a strong disease-modifying therapy taken for at least 6 months
  • For the progressive MS group: a diagnosis of primary progressive MS or non-relapsing secondary progressive MS, a disability score (EDSS) between 3.0 and 6.5, and either not responding well or being intolerant to at least one strong disease-modifying therapy taken for at least 6 months

Who may not be able to

  • Previous treatment with CAR-T or CAR-NK cell therapies
  • Spleen removed within the past 12 months
  • Ever had a solid organ transplant, or on a transplant waiting list
  • Previous stem cell transplant (using your own cells) or total lymphoid irradiation
  • Serious heart conditions that would make taking part too risky
  • Other nervous system conditions, such as epilepsy, stroke, severe brain injury, dementia, Parkinson's disease, psychosis, or a history of seizures
  • A significant psychiatric condition, now or in the past
  • Another immune-mediated disease needing long-term immune-suppressing treatment
  • Significant bleeding problems within 90 days before screening
  • History of cancer or current cancer treatment
  • Born with an immune system problem (primary immunodeficiency)
  • Positive for HIV or HTLV, or active viral hepatitis (including hepatitis B or C)
  • Major surgery within 4 weeks before a procedure called apheresis or lymphodepletion, or surgery planned during the study or within 4 weeks after treatment
  • Pregnant, breastfeeding, or planning a pregnancy during the study or within 1 year after treatment (whichever is longer)
  • Unable or unsafe to have lumbar punctures (spinal fluid tests) or MRI scans

What taking part involves

  • • Taking the study medicine AZD0120 — Not stated — ask the trial team for details on how it is given and how often
  • • The study mentions procedures including apheresis (collecting cells from your blood), lymphodepletion (treatment to lower some immune cells), lumbar punctures (spinal fluid tests), and MRI scans

Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years to 60 Years
Who
All
Number of participants
24
Started
2025-12-09
Last checked
2026-08

Plain English Summary

What is this study?

  • • Testing a new treatment for multiple sclerosis
  • • Phase1 - 24 participants
  • • 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

Who can take part?

  • • Ages 18 Years to 60 Years
  • • Diagnosed with multiple sclerosis

Where?

  • • Cambridge - Research Site
  • • London - Research Site

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

This study will evaluate AZD0120 for safety, including DLTs and TEAEs, by the SRC for determination of the Recommended Phase 2 dose for each disease cohort. Approximately 9-12 participants will be evaluated per disease cohort.

Multiple Sclerosis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 60 Years
  • Who can join: All genders

Treatment history

Treatments you must have had:

  • ✓ an EDSS of ≥ 3
  • ✓ autologous hematopoietic stem cell transplantation
  • ✓ continued systemic immunosuppression/systemic disease-modifying agents

What the study is looking for

  • ✓Participants are eligible to be included in the study only if all of the following criteria apply:
  • ✓Age ≥ 18-years-old to ≤ 60-years-old at the time of consent
  • ✓Type of Participant and Disease Characteristics
  • ✓Written agreement to take part in accordance with federal, local, and institutional guidelines
  • ✓healthy physiological and reserve at screening
See the full 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 Is This Study? (2 UK sites)

Research Site

Cambridge CB2 2QQ, United Kingdom

WITHDRAWN

Research Site

London SE5 9RS, United Kingdom

WITHDRAWN

How to Get in Touch

AstraZeneca Clinical Study Information Center

Sponsor contact

CONTACT

1-877-240-9479 information.center@astrazeneca.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-08