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Engineered immune cells take aim at autoimmune diseases

NCT ID NCT07295847

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 4 times

Summary

This early-stage trial tests a new treatment called AZD0120 for adults with three autoimmune diseases: systemic sclerosis, idiopathic inflammatory myopathies, or difficult-to-treat rheumatoid arthritis. AZD0120 is made from a patient's own immune cells, which are modified in a lab to target and attack faulty cells that drive the disease. The main goal is to check the treatment's safety and find the right dose for future studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 27 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Capable of giving signed informed consent. * Adequate physiological function and reserve at screening. * Able to comply with recommended medication washout period. * Participants who are suitable for the study as determined by medical evaluation and at the discretion of the investigator. * Willingness to remain on/start appropriate, highly effective methods of birth control or other acceptable criteria. Exclusion Criteria: * BMI at screening \< 18 or \> 35kg/m2. * Any prior CAR T exposure. * Unable or unwilling to remain within proximity (\~2 hours travel time) of the administering investigational site for the first 28 days post study drug administration. * Received a bone marrow or solid organ transplant at any time or on an active transplant waiting list. * Received any investigational drug within ≥ 5 half-lives or 4 weeks, whichever is longer, prior to screening. * Has certain heart conditions that could make it unsafe or unsuitable to take part in the study. * Requirement for supplemental oxygen at rest (except at night for sleep apnea) or mechanical ventilation. * Uncontrolled hypertension (\> 160/100 mmHg) or symptomatic hypertension. * Any central nervous system disease that may impact participants safety in the investigator's opinion. * Other concurrent autoimmune or autoinflammatory disease. Certain autoimmune/autoinflammatory diseases may be included after discussion with the medical monitor. * Evidence of clinically significant bleeding or active bleeding conditions within 90 days before screening * History of malignancy or ongoing treatment for prior malignancy. Certain malignancies may be excepted. * Known genetic inborn error of immunity and/or primary immunodeficiency. * Active viral, bacterial, or fungal infection, or any ongoing infection that requires systemic antimicrobial therapy in the 4 weeks prior to screening. * Seropositive for HIV. * Active viral hepatitis are excluded. * Active syphilis, positive for Treponema pallidum antibody. * Vaccinated with live, attenuated vaccine within 4 weeks prior to apheresis or lymphodepletion. * Not up-to-date on vaccinations per local/national health authority or institutional guidelines for immune-compromised individuals. * Known life threatening allergies, hypersensitivity, or intolerance to AZD0120 or its excipients, including dimethyl sulfoxide. * Contraindications or hypersensitivity to fludarabine and cyclophosphamide. * Major surgery, or has surgery planned during the study. * Pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 1 year after receiving study treatment (whichever is later). * Plans to father a child while enrolled in this study or within 1 year after receiving study treatment (whichever is later). * Any issue that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to provide informed consent or any condition in the opinion of the investigator, participation would not be in the best interest of the participant. Other protocol-defined eligibility criteria may apply.

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Conditions

The condition(s) this trial relates to.

acquired idiopathic inflammatory myopathy myositis disease rheumatoid arthritis systemic sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic inflammatory myopathies Rheumatoid arthritis Systemic sclerosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    22 sites in 6 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    NOT_YET_RECRUITING

    Tucson, Arizona, 85719, United States

  • Research Site

    NOT_YET_RECRUITING

    Stanford, California, 94305-5847, United States

  • Research Site

    NOT_YET_RECRUITING

    Chicago, Illinois, 60637, United States

  • Research Site

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

  • Research Site

    NOT_YET_RECRUITING

    St Louis, Missouri, 63110, United States

  • Research Site

    RECRUITING

    New York, New York, 10032, United States

  • Research Site

    NOT_YET_RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • Research Site

    NOT_YET_RECRUITING

    Seattle, Washington, 98104, United States

  • Research Site

    RECRUITING

    Darlinghurst, 2010, Australia

  • Research Site

    NOT_YET_RECRUITING

    Waratah, 2298, Australia

  • Research Site

    NOT_YET_RECRUITING

    Berlin, 13353, Germany

  • Research Site

    NOT_YET_RECRUITING

    Erlangen, 91054, Germany

  • Research Site

    NOT_YET_RECRUITING

    Hamburg, 20246, Germany

  • Research Site

    NOT_YET_RECRUITING

    Jena, 07747, Germany

  • Research Site

    NOT_YET_RECRUITING

    Mainz, 55131, Germany

  • Research Site

    NOT_YET_RECRUITING

    Würzburg, 97080, Germany

  • Research Site

    NOT_YET_RECRUITING

    Barcelona, 8035, Spain

  • Research Site

    NOT_YET_RECRUITING

    Madrid, 28041, Spain

  • Research Site

    NOT_YET_RECRUITING

    Madrid, 28046, Spain

  • Research Site

    NOT_YET_RECRUITING

    Huddinge, 141 57, Sweden

  • Research Site

    RECRUITING

    Edinburgh, EH4 2XU, United Kingdom

  • Research Site

    NOT_YET_RECRUITING

    London, SE5 9RS, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.