Actively Recruiting
A Study of AZD0120 in Autoimmune Diseases
Led by AstraZeneca · Updated on 2026-05-01
27
Participants Needed
18
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a Phase 1b, 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).
CONDITIONS
Official 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
- Willing to remain on or start effective birth control methods or other acceptable criteria
You will not qualify if you...
- Body mass index (BMI) less than 18 or greater than 35 kg/m2 at screening
- Prior exposure to CAR T-cell therapy
- Unable or unwilling to stay within about 2 hours travel time from study site for first 28 days post treatment
- Received a bone marrow or solid organ transplant at any time or on active transplant waiting list
- Took any investigational drug within 5 half-lives or 4 weeks before screening, whichever is longer
- Certain heart conditions that make participation unsafe or unsuitable
- Need for supplemental oxygen at rest (except nighttime sleep apnea) or mechanical ventilation
- Uncontrolled or symptomatic hypertension (blood pressure over 160/100 mmHg)
- Any central nervous system disease affecting safety as judged by investigator
- Other concurrent autoimmune or autoinflammatory diseases unless approved by medical monitor
- Clinically significant bleeding or active bleeding within 90 days before screening
- History of malignancy or ongoing treatment for prior malignancy except certain exceptions
- Known genetic immune deficiencies or primary immunodeficiency
- Active viral, bacterial, or fungal infection requiring systemic antimicrobial therapy within 4 weeks before screening
- Seropositive for HIV
- Active viral hepatitis
- Active syphilis or positive Treponema pallidum antibody
- Vaccinated with live attenuated vaccine within 4 weeks before apheresis or lymphodepletion
- Not up-to-date on vaccinations as per local or institutional guidelines for immunocompromised individuals
- Known life-threatening allergies, hypersensitivity, or intolerance to AZD0120 or its components including dimethyl sulfoxide
- Contraindications or hypersensitivity to fludarabine and cyclophosphamide
- Major surgery planned or done during study
- Pregnant, breastfeeding, or planning pregnancy while enrolled or within 1 year after treatment
- Planning to father a child while enrolled or within 1 year after treatment
- Any condition impairing ability to receive or tolerate treatment, provide consent, or not in participant's best interest 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
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
CONTACT
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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