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Multiple SclerosisPhase 1ZENITHNCT07224373

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

A Phase 1 study testing AZD0120 - Regimen 1 and AZD0120 - Regimen 2 in people with Multiple Sclerosis, run by AstraZeneca at 19 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
AZD0120 - Regimen 1 and AZD0120 - Regimen 2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
19 sitesin 5 countries
Study dates
9 Dec 2025to 12 Dec 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

None listed.

Who cannot join

  • 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:
Show all 19Show fewer
  • 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.

Trial locations and contacts

19 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

AstraZeneca Clinical Study Information Center contact

1-877-240-9479

information.center@astrazeneca.com

19 sites in 5 countries

United States9 sites, 8 recruiting

  • Research Site

    Aurora, Colorado, 80045

    Not yet recruiting

  • Research Site

    Cleveland, Ohio, 44195

    Not yet recruiting

  • Research Site

    Milwaukee, Wisconsin, 53226

    Recruiting

  • Research Site

    New York, New York, 10016

    Recruiting

  • Research Site

    New York, New York, 10032

    Recruiting

  • Research Site

    Seattle, Washington, 98122

    Recruiting

  • Research Site

    St Louis, Missouri, 63110

    Recruiting

  • Research Site

    Tucson, Arizona, 85719

    Withdrawn

  • Research Site

    Washington D.C., District of Columbia, 20010

    Recruiting

Other trials in United States

Australia4 sites, 4 recruiting

  • Research Site

    Liverpool, 2170

    Not yet recruiting

  • Research Site

    Melbourne, 3000

    Recruiting

  • Research Site

    Melbourne, 3004

    Not yet recruiting

  • Research Site

    Waratah, 2298

    Not yet recruiting

Other trials in Australia

Germany3 sites

  • Research Site

    Leipzig, 04103

    Withdrawn

  • Research Site

    Magdeburg, 39120

    Withdrawn

  • Research Site

    Würzburg, DE-97072

    Withdrawn

Other trials in Germany

United Kingdom2 sites

  • Research Site

    Cambridge, CB2 2QQ

    Withdrawn

  • Research Site

    London, SE5 9RS

    Withdrawn

Other trials in United Kingdom

Canada1 site, 1 recruiting

  • Research Site

    Montreal, Quebec, H3A 1A1

    Not yet recruiting

Other trials in Canada

About this study

Official title: 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

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.

Read the detailed description

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.

Being tested
AZD0120 - Regimen 1, AZD0120 - Regimen 2
Keywords
AZD0120, Multiple Sclerosis, MS, RMS, PMS
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD0120 - Regimen 1Biological

    Regimen 1, infusion of AZD0120

  • AZD0120 - Regimen 2Biological

    Regimen 2, infusion of AZD0120

Study groups in NCT07224373
Study groupRoleWhat they receive
Arm/Group 1: AZD0120 RMSExperimentalAZD0120 RMS
Receives: Biological: AZD0120 - Regimen 1; Biological: AZD0120 - Regimen 2
Arm/Group 2: AZD0120 PMSExperimentalAZD0120 PMS
Receives: Biological: AZD0120 - Regimen 1; Biological: AZD0120 - Regimen 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the safety, and tolerability of AZD0120 in participants with MS (disease cohort 1: RMS; disease cohort 2: PMS)

    Incidence and severity of Dose Limiting Toxicity (DLT) over 104 weeks following AZD0120 administration.

    Measured: Day 1 to day 29, and over 104 weeks

  2. Evaluate the safety, and tolerability of AZD0120 in participants with MS (disease cohort 1: RMS; disease cohort 2: PMS)

    Incidence and severity of Adverse Events (AE) over 104 weeks following AZD0120 administration.

    Measured: Day 1 to day 29, and over 104 weeks

  3. Evaluate the safety, and tolerability of AZD0120 in participants with MS (disease cohort 1: RMS; disease cohort 2: PMS)

    Incidence and severity of Serious Adverse Events (SAE) over 104 weeks following AZD0120 administration.

    Measured: Day 1 to day 29, and over 104 weeks

  4. Evaluate the safety, and tolerability of AZD0120 in participants with MS (disease cohort 1: RMS; disease cohort 2: PMS)

    Incidence and severity of Treatment Emergent Adverse Events (TEAE) over 104 weeks following AZD0120 administration.

    Measured: Day 1 to day 29, and over 104 weeks

Secondary outcomes (33)

  1. Evaluate the optimum regimen with AZD0120 in MS participants to determine the RP2D in each disease cohort

    Change from baseline in peripheral B-cell counts following AZD0120 administration

    Measured: Over 104 weeks

  2. Evaluate the optimum regimen with AZD0120 in MS participants to determine the RP2D in each disease cohort

    CK parameters in peripheral B-cell counts following AZD0120 administration

    Measured: Over 104 weeks

  3. Evaluate the preliminary efficacy of AZD0120 in RMS and PMS

    Annualized Relapse Rate (ARR) over 104 weeks (RMS cohort only)

    Measured: Over 104 weeks

  4. Evaluate the preliminary efficacy of AZD0120 in RMS and PMS

    Time to onset participants with CDP-12 over 104 weeks

    Measured: Over 104 weeks

  5. Evaluate the preliminary efficacy of AZD0120 in RMS and PMS

    Proportion of participants with CDP-12 over 104 weeks

    Measured: Over 104 weeks

  6. Evaluate the preliminary efficacy of AZD0120 in RMS and PMS

    Time to onset participants with CDP-24 over 104 weeks

    Measured: Over 104 weeks

  7. Evaluate the preliminary efficacy of AZD0120 in RMS and PMS

    Proportion of participants with CDP-24 over 104 weeks

    Measured: Over 104 weeks

  8. Evaluate the preliminary efficacy of AZD0120 in RMS and PMS

    Proportion of participants achieving CDI

    Measured: Over 104 weeks

  9. Evaluate the preliminary efficacy of AZD0120 in RMS and PMS

    Change from baseline in 9HPT (9-Hole Peg Test)

    Measured: Over 104 weeks

  10. Evaluate the preliminary efficacy of AZD0120 in RMS and PMS

    Change from baseline in T25FW (Timed 25-Foot Walk)

    Measured: Over 104 weeks

  11. Evaluate the preliminary efficacy of AZD0120 in RMS and PMS

    Change from baseline in EDSS (Expanded Disability Status Scale)

    Measured: Over 104 weeks

  12. Evaluate the preliminary efficacy of AZD0120 in RMS and PMS

    Change from baseline in SDMT (Symbol Digit Modalities Test)

    Measured: Over 104 weeks

  13. Evaluate the preliminary efficacy of AZD0120 in RMS and PMS

    Proportion of participants with NEDA-3 (No Evidence of Disease Activity)

    Measured: Over 104 weeks

  14. Evaluate the preliminary efficacy of AZD0120 in RMS and PMS

    Proportion of participants with PIRA (Progression Independent of Relapse Activity)

    Measured: Over 104 weeks

  15. Evaluate the preliminary efficacy of AZD0120 in RMS and PMS

    Change from screening in MRI parameters including: mean number of Gd+ T1 lesions over time

    Measured: Over 104 weeks

  16. Evaluate the preliminary efficacy of AZD0120 in RMS and PMS

    Change from screening in MRI parameters including: mean number of new or enlarging T2 hyperintense lesions

    Measured: Over 104 weeks

  17. Evaluate the preliminary efficacy of AZD0120 in RMS and PMS

    Change from screening in MRI parameters including brain volume

    Measured: Over 104 weeks

  18. Evaluate the preliminary efficacy of AZD0120 in RMS and PMS

    Change in MRI parameters including: mean number of Gd+ T1 lesions over time.

    Measured: Over 104 weeks

  19. Evaluate the preliminary efficacy of AZD0120 in RMS and PMS

    Change in MRI parameters including: mean number of new or enlarging T2 hyperintense lesions

    Measured: Over 104 weeks

  20. Investigate the effects of AZD0120 on the function and quality of life of participants with MS

    Change in SF-36v2 from baseline

    Measured: Over 104 weeks

  21. Investigate the effects of AZD0120 on the function and quality of life of participants with MS

    Change in Neuro-QoL-fatigue from baseline

    Measured: Over 104 weeks

  22. Characterize the CK and PD of AZD0120 in participants with MS

    Quantification of CAR transgene levels of AZD0120 in blood and CSF.

    Measured: Over 104 weeks

  23. Characterize the CK and PD of AZD0120 in participants with MS

    Cmax

    Measured: Over 104 weeks

  24. Characterize the CK and PD of AZD0120 in participants with MS

    AUC(0-28).

    Measured: Over 104 weeks

  25. Characterize the CK and PD of AZD0120 in participants with MS

    AUClast.

    Measured: Over 104 weeks

  26. Characterize the CK and PD of AZD0120 in participants with MS

    Clast.

    Measured: Over 104 weeks

  27. Characterize the CK and PD of AZD0120 in participants with MS

    Tmax.

    Measured: Over 104 weeks

  28. Characterize the CK and PD of AZD0120 in participants with MS

    Tlast.

    Measured: Over 104 weeks

  29. Characterize the CK and PD of AZD0120 in participants with MS

    B-cell counts

    Measured: Over 104 weeks

  30. To monitor the incidence of vector-derived RCL

    Proportion of participants with detectable RCL at pre-specified post infusion timepoints

    Measured: Over 104 weeks

  31. To assess the immunogenicity of AZD0120 in participants.

    Proportion of participants who develop anti- AZD0120 antibodies

    Measured: over 104 weeks

  32. To assess the immunogenicity of AZD0120 in participants.

    Time to development of anti-AZD0120 antibodies

    Measured: over 104 weeks

  33. To assess the immunogenicity of AZD0120 in participants.

    Changes in anti-AZD0120 antibody titers over 104 weeks

    Measured: over 104 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2025
  2. Study start9 Dec 2025
  3. Primary completion12 Dec 2028 (estimated)
  4. Study completion12 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07224373
Sponsor's protocol ID
D831DC00001
Other IDs
29707
Acronym
ZENITH
Status last verified
Aug 2026
First submitted
21 Oct 2025
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AZD0120 - Regimen 1 and AZD0120 - Regimen 2 in people with Multiple Sclerosis, run by AstraZeneca at 19 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Australia, Germany, United Kingdom, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact AstraZeneca Clinical Study Information Center (1-877-240-9479, information.center@astrazeneca.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the safety, and tolerability of AZD0120 in participants with MS (disease cohort 1: RMS; disease cohort 2: PMS) (time frame: Day 1 to day 29, and over 104 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07224373.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.

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