Actively Recruiting
A Phase 1b, Open-label, Multi-cohort Study of AZD0120, an Autologous CD19/BCMA Targeting Chimeric Antigen Receptor T-cell, in Adults With Autoimmune Diseases
Led by AstraZeneca · Updated on 2026-06-02
27
Participants Needed
18
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating AZD0120, a CD19/BCMA dual targeting CAR T-cell therapy, in adult participants with autoimmune diseases including systemic sclerosis, idiopathic inflammatory myopathies, or difficult-to-treat rheumatoid arthritis. This Phase 1b, open-label, multi-center study aims to assess the safety and tolerability of this therapy and determine the recommended dose for each disease group. Approximately 9 to 12 participants will be studied in each disease cohort. Participants will receive one of two infusion regimens of AZD0120. The study includes different cohorts based on the specific autoimmune condition, and each participant will undergo treatment with one of the two regimens. This therapy uses the participant's own modified T-cells targeting specific proteins (CD19 and BCMA) associated with their disease. During the study, participants will be closely monitored for dose-limiting toxicities and treatment-emergent adverse events over one year. Researchers will also evaluate how the therapy behaves in the body, including cellular kinetics and immune response. Disease activity and improvement will be measured using standardized scores for skin thickness, disease activity, and overall improvement. Safety and treatment effects will be assessed regularly throughout the study duration, which may last up to one year after treatment.
CONDITIONS
Brief Title
A Study of AZD0120 in Autoimmune Diseases
Who Can Participate
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 remain on or start effective birth control methods or meet other acceptable criteria.
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 stay within approximately 2 hours of the study site for 28 days after treatment.
- Received bone marrow or solid organ transplant at any time or currently on transplant waiting list.
- Received any investigational drug within 5 half-lives or 4 weeks before screening.
- Certain heart conditions that may make participation unsafe.
- Need for supplemental oxygen at rest (except nighttime sleep apnea) or mechanical ventilation.
- Uncontrolled or symptomatic hypertension.
- Central nervous system disease affecting safety as judged by investigator.
- Other concurrent autoimmune or autoinflammatory diseases unless approved by medical monitor.
- Active or significant bleeding conditions within 90 days before screening.
- History of malignancy or ongoing treatment for malignancy, with some exceptions.
- Known genetic immune disorders or primary immunodeficiency.
- Active infections requiring treatment within 4 weeks before screening.
- Positive for HIV, active viral hepatitis, or active syphilis.
- Vaccinated with live vaccine within 4 weeks before certain study procedures.
- Not up-to-date on vaccinations for immune-compromised individuals.
- Known life-threatening allergies or intolerance to AZD0120 or its components.
- Contraindications or hypersensitivity to fludarabine or cyclophosphamide.
- Recent or planned major surgery during the study.
- Pregnant, breastfeeding, or planning pregnancy during or within 1 year after treatment.
- Plans to father a child during or within 1 year after treatment.
- Any condition impairing ability to receive or tolerate treatment or provide informed consent as judged by investigator.
- Other protocol-defined eligibility criteria may apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants receive an infusion of AZD0120, a CD19/BCMA dual CAR T-cell therapy, to evaluate safety and determine the recommended dose.
Multiple visits for treatment and monitoring during the year
Trial Site Locations
Total: 18 locations
1
Research Site
Tucson, Arizona, United States, 85719
Not Yet Recruiting
2
Research Site
Stanford, California, United States, 94305-5847
Not Yet Recruiting
3
Research Site
Chicago, Illinois, United States, 60637
Not Yet Recruiting
4
Research Site
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
5
Research Site
St Louis, Missouri, United States, 63110
Not Yet Recruiting
6
Research Site
New York, New York, United States, 10032
Actively Recruiting
7
Research Site
Chapel Hill, North Carolina, United States, 27599
Not Yet Recruiting
8
Research Site
Seattle, Washington, United States, 98104
Not Yet Recruiting
9
Research Site
Darlinghurst, Australia, 2010
Actively Recruiting
10
Research Site
Waratah, Australia, 2298
Not Yet Recruiting
11
Research Site
Hamburg, Germany, 20246
Not Yet Recruiting
12
Research Site
Mainz, Germany, 55131
Not Yet Recruiting
13
Research Site
Würzburg, Germany, 97080
Not Yet Recruiting
14
Research Site
Barcelona, Spain, 8035
Not Yet Recruiting
15
Research Site
Madrid, Spain, 28041
Not Yet Recruiting
16
Research Site
Madrid, Spain, 28046
Not Yet Recruiting
17
Research Site
Edinburgh, United Kingdom, EH4 2XU
Not Yet Recruiting
18
Research Site
London, United Kingdom, SE5 9RS
Not Yet Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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