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AZD0120 for Autoimmune Diseases

This study is testing a new treatment called AZD0120, which is a type of CAR T-cell therapy (a treatment that uses your own modified immune cells). It's for adults aged 18 to 75 with systemic sclerosis (a disease causing hardening of the skin and organs), idiopathic inflammatory myopathies (muscle inflammation), or difficult-to-treat rheumatoid arthritis (a chronic inflammatory disorder affecting joints). The main goal of this study is to see how safe AZD0120 is and what side effects it might cause over one year. We are looking for about 27 participants in total. The study is currently unclear about its recruitment status.

Study design
This is a Phase 1b, open-label study, meaning both you and your doctors will know which treatment you are receiving. It will include approximately 27 participants across multiple locations.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study will measure safety and side effects for one year after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07295847

A Study of AZD0120 in Autoimmune Diseases

Recruiting
PHASE1Ages 18–75InterventionalTreatment
AstraZeneca
~27 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:AZD0120

At a glance

Recruiting sites
4 of 22 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants and severity of dose limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs)
Measured over 1 year

Conditions

Systemic Sclerosis
Idiopathic Inflammatory Myopathies
Rheumatoid Arthritis

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Where it's being run

22 sites across 13 states
Germany6
Spain3
Australia2
United Kingdom2
Arizona1
California1
Illinois1
Michigan1

Who to contact

AstraZeneca Clinical Study Information Center
[email protected]
1-877-240-9479
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Number of participants and severity of dose limiting toxicities (DLTs) and treatment-emergent adverse events (TEAEs)1 year

    Incidence and severity of DLTs and TEAEs to evaluate the safety of AZD0120 and to confirm the recommended Phase 2 dose (RP2D) in each indication SSc, IIM, or RA