What is AZD0120 studying for autoimmune diseases?

AZD0120 is being studied to evaluate its safety and tolerability in adults with autoimmune diseases such as systemic sclerosis, idiopathic inflammatory myopathies, and difficult-to-treat rheumatoid arthritis. This research aims to determine the recommended dose and monitor how the therapy behaves in the body. The study is sponsored by AstraZeneca and involves adult participants receiving CAR T-cell therapy infusions.

Who may be eligible for this autoimmune disease clinical trial?

Adults aged 18 to 75 years with systemic sclerosis, idiopathic inflammatory myopathies, or difficult-to-treat rheumatoid arthritis may be eligible. Participants must be able to give informed consent, have adequate physiological function, and comply with medication washout periods. Both sexes can participate. Please review eligibility criteria for more details.

Is there any cost to participate in this autoimmune disease clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation needs.

Actively Recruiting

Phase 1

Age: 18Years - 75Years

All Genders

ID07295847

Phase 1b Study of AZD0120, a CD19BCMA Dual CAR T-cell Therapy, for Adults Aged 18 to 75 With Systemic Sclerosis, Idiopathic Inflammatory Myopathies, or Difficult-to-Treat Rheumatoid Arthritis

Led by AstraZeneca · Updated on 2026-07-28

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating AZD0120, a CD19BCMA dual targeting CAR T-cell therapy, in adults with autoimmune diseases including systemic sclerosis SSc, idiopathic inflammatory myopathies IIM, and difficult-to-treat rheumatoid arthritis D2T RA. This Phase 1b, open-label, multi-center study aims to assess the safety and tolerability of AZD0120 and to determine the recommended dose for each disease group. Approximately 9 to 12 participants will be studied in each disease category. Participants will receive an infusion of one of two AZD0120 regimens. The study is designed as a multi-cohort trial with parallel groups, where each participant receives the assigned CAR T-cell therapy infusion. The main focus is on monitoring dose-limiting toxicities and treatment-emergent adverse events over one year. Secondary outcomes include various cellular kinetics measures, antibody development, viral replication presence, and changes in disease activity and skin scores over the same period. During the study, participants will be closely monitored with clinical evaluations and laboratory tests to assess safety and therapeutic effects. Measurements such as Disease Activity Score DAS 28-CRP, modified Rodnan Skin Score mRSS, and total improvement scores will be tracked. Participants must comply with study requirements including medication washout periods and use of effective birth control. The overall participation involves intensive follow-up for one year to evaluate safety and disease response after receiving the AZD0120 infusion.

CONDITIONS

Brief Title

A Study of AZD0120 in Autoimmune Diseases

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Capable of giving signed informed consent.
Adequate physiological function and reserve at screening.
Able to comply with recommended medication washout period.
Suitable for the study as determined by medical evaluation and investigator discretion.
Willingness to use appropriate, highly effective birth control or other acceptable methods.

You will not qualify if you...

Body mass index (BMI) less than 18 or greater than 35 kg/m2.
Prior exposure to CAR T-cell therapy.
Unable or unwilling to remain within approximately 2 hours travel time of the investigational site for 28 days after study drug administration.
History of bone marrow or solid organ transplant, or currently on a transplant waiting list.
Use of investigational drugs within 5 half-lives or 4 weeks before screening.
Certain heart conditions making participation unsafe.
Requirement for supplemental oxygen at rest (except at night for sleep apnea) or mechanical ventilation.
Uncontrolled or symptomatic hypertension (greater than 160/100 mmHg).
Central nervous system disease affecting safety.
Other concurrent autoimmune or autoinflammatory diseases unless approved by medical monitor.
Clinically significant bleeding within 90 days before screening.
History of malignancy or current treatment for malignancy unless excepted.
Known genetic inborn error of immunity or primary immunodeficiency.
Active infections requiring systemic antimicrobial therapy within 4 weeks before screening.
Seropositive for HIV.
Active viral hepatitis or syphilis infection.
Vaccination with live attenuated vaccine within 4 weeks prior to apheresis or lymphodepletion.
Not up-to-date on vaccinations per local guidelines for immunocompromised individuals.
Life-threatening allergies or intolerance to AZD0120 or its components.
Contraindications or hypersensitivity to fludarabine and cyclophosphamide.
Major surgery planned or recent major surgery.
Pregnant, breastfeeding, or planning pregnancy during the study or within 1 year after treatment.
Plans to father a child during the study or within 1 year after treatment.
Any condition impairing ability to receive or tolerate treatment or provide informed consent in the investigator's opinion.

Research Team

AstraZeneca Clinical Study Information Center

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Phase 1b Study of AZD0120, a CD19BCMA Dual CAR T-cell Therapy, for Adults Aged 18 to 75 With Systemic Sclerosis, Idiopathic Inflammatory Myopathies, or Difficult-to-Treat Rheumatoid Arthritis

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria