A Study of AZD0120 in Autoimmune Diseases

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type

Interventional

Phase

Phase 1 / Phase 2

Age range

18 years - 75 years

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

27 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

This trial is a Phase 1b/2, 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 systemic sclerosis (SSc), idiopathic inflammatory myopathies (IIM), or difficult-to-treat rheumatoid arthritis (D2T RA).

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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.
• Particpant musy be 18-years-old to ≤ 75-years-old inclusive at the time of signing the informed consent
• Others as described in Clinical Study Protocol

Exclusion Criteria:

• Any prior CAR T exposure.
• Unable or unwilling to remain within proximity (2 hours travel time) of the administering investigational site post discharge for the first 28 days post AZD0120 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 cardiac 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 or HTLV.
• 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 within 8 weeks prior to apheresis 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.

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Secondary measures

Research locations (27)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

27 locations

Study team and timeline

Lead sponsor

AstraZeneca

Study start

Jan 9, 2026 Actual

Primary completion

Feb 22, 2028 Estimated

Study completion

Feb 22, 2028 Estimated

First posted

Dec 22, 2025 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts