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Engineered immune cells take aim at Hard-to-Treat lupus

NCT ID NCT06897930

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 11, 2026 · Updated 7 times

Summary

This study tests a new treatment called AZD0120 for people with severe lupus that hasn't improved with standard therapies. AZD0120 is a type of CAR T cell therapy that targets two proteins (CD19 and BCMA) on immune cells to calm the overactive immune system. The trial will enroll 150 adults and first check safety and dosing, then measure how well it controls lupus symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AZD0120 (a dual-target CAR T cell therapy that attacks CD19 and BCMA proteins on immune cells)
What this could lead to
If successful, this could offer a new treatment option for people with severe lupus that hasn't responded to other therapies, potentially reducing disease activity without lifelong medication.
What could go wrong
This is an early-phase trial (1b/2) with only 150 participants, so results may not apply to all lupus patients. CAR T therapy carries risks like cytokine release syndrome and infections, and long-term safety is unknown.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 150 people

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

Started

Apr 2025

Expected to finish

May 2029

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 70 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: 1. Males or females aged 18 through 70 years inclusive at the time of consent. 2. Written informed consent in accordance with federal, local, and institutional guidelines. 3. Must be able and willing to adhere to the study visit schedule and other protocol requirements 4. Adequate hepatic, renal, pulmonary, and cardiac function 5. Have a clinical diagnosis of SLE according to the EULAR/ American College of Rheumatology (ACR) 2019 criteria with a positive ANA ≥1:80 and a score ≥10. 6. Have used at least two standard immunosuppressants (including one biological agent). 7. SLEDAI-2K score ≥6 at screening. 8. Must include a significant SLE related organ involvement: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, vasculitis, or renal. 9. For lupus nephritis: Diagnosis of proliferative lupus nephritis based on a renal biopsy obtained within 6 months prior to signing the informed consent form or during the screening period Class III, IV or V LN according to the WHO 2003 ISN/RPS classification. EXCLUSION: 1. Have received prior treatment with CAR T therapy directed at any target. 2. Have received any therapy that is targeted to CD19 and/or BCMA 3. Received allogenic stem cell transplant or autologous stem cell transplant. 4. An active malignancy that is progressing or requires active treatment. 5. Primary immunodeficiency 6. Active viral or bacterial infection

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Conditions

The condition(s) this trial relates to.

lupus nephritis systemic lupus erythematosus

As listed by the trial registrant

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

Lupus erythematosus, systemic

How to take part

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

  1. The places running it

    19 sites in 4 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

    RECRUITING

    San Francisco, California, 94143, United States

  • Research Site

    NOT_YET_RECRUITING

    Stanford, California, 94304-2201, United States

  • Research Site

    SUSPENDED

    Tampa, Florida, 33612, United States

  • Research Site

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Research Site

    NOT_YET_RECRUITING

    Chicago, Illinois, 60611, United States

  • Research Site

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21287, United States

  • Research Site

    WITHDRAWN

    Bethesda, Maryland, 20892, United States

  • Research Site

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Research Site

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Research Site

    RECRUITING

    New York, New York, 10032, United States

  • Research Site

    RECRUITING

    Syracuse, New York, 13202-2240, United States

  • Research Site

    RECRUITING

    Chapel Hill, North Carolina, 27599-7280, United States

  • Research Site

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Research Site

    NOT_YET_RECRUITING

    Richmond, Virginia, 23298, United States

  • Research Site

    RECRUITING

    Seattle, Washington, 98104, United States

  • Research Site

    RECRUITING

    Seattle, Washington, 98195, United States

  • Research Site

    RECRUITING

    Darlinghurst, 2010, Australia

  • Research Site

    NOT_YET_RECRUITING

    Melbourne, 3000, Australia

  • Research Site

    NOT_YET_RECRUITING

    Toronto, M5T 2S8, Canada

  • Research Site

    NOT_YET_RECRUITING

    Bristol, BS1 3NU, United Kingdom

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