Actively Recruiting
A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE
Led by AstraZeneca · Updated on 2026-05-12
150
Participants Needed
18
Research Sites
210 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 1b/2, single-arm, open-label, multi-center, clinical study of AZD0120, a CD19/BCMA dual CAR T cell therapy, to evaluate the safety, tolerability, and efficacy in adult participants with refractory Systemic Lupus Erythematosus.
CONDITIONS
Official Title
A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 18 through 70 years inclusive at the time of consent.
- Written informed consent in accordance with federal, local, and institutional guidelines.
- Must be able and willing to adhere to the study visit schedule and other protocol requirements.
- Adequate hepatic, renal, pulmonary, and cardiac function.
- Have a clinical diagnosis of SLE according to the EULAR/American College of Rheumatology (ACR) 2019 criteria with a positive ANA 1:80 and a score 10.
- Have used at least two standard immunosuppressants (including one biological agent).
- SLEDAI-2K score 6 at screening.
- Must include a significant SLE related organ involvement: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, vasculitis, or renal.
- For lupus nephritis: Diagnosis of proliferative lupus nephritis based on a renal biopsy obtained within 6 months prior to signing the informed consent form or during the screening period Class III, IV or V LN according to the WHO 2003 ISN/RPS classification.
You will not qualify if you...
- Have received prior treatment with CAR T therapy directed at any target.
- Have received any therapy that is targeted to CD19 and/or BCMA.
- Received allogenic stem cell transplant or autologous stem cell transplant.
- An active malignancy that is progressing or requires active treatment.
- Primary immunodeficiency.
- Active viral or bacterial infection.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Research Site
San Francisco, California, United States, 94143
Not Yet Recruiting
2
Research Site
Stanford, California, United States, 94304-2201
Not Yet Recruiting
3
Research Site
Tampa, Florida, United States, 33612
Suspended
4
Research Site
Atlanta, Georgia, United States, 30322
Not Yet Recruiting
5
Research Site
Chicago, Illinois, United States, 60611
Not Yet Recruiting
6
Research Site
Bethesda, Maryland, United States, 20892
Withdrawn
7
Research Site
Boston, Massachusetts, United States, 02115
Actively Recruiting
8
Research Site
St Louis, Missouri, United States, 63110
Not Yet Recruiting
9
Research Site
New York, New York, United States, 10032
Actively Recruiting
10
Research Site
Syracuse, New York, United States, 13202-2240
Actively Recruiting
11
Research Site
Chapel Hill, North Carolina, United States, 27599-7280
Not Yet Recruiting
12
Research Site
Charlotte, North Carolina, United States, 28204
Actively Recruiting
13
Research Site
Richmond, Virginia, United States, 23298
Not Yet Recruiting
14
Research Site
Seattle, Washington, United States, 98104
Actively Recruiting
15
Research Site
Seattle, Washington, United States, 98195
Actively Recruiting
16
Research Site
Darlinghurst, Australia, 2010
Not Yet Recruiting
17
Research Site
Melbourne, Australia, 3000
Not Yet Recruiting
18
Research Site
Toronto, Canada, M5T 2S8
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
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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