Actively Recruiting
A Phase 1b/2 Study of AZD0120, a Chimeric Antigen Receptor T-cell Therapy Targeting CD19 and BCMA in Adults With Refractory Systemic Lupus Erythematosus
Led by AstraZeneca · Updated on 2026-05-12
150
Participants Needed
18
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying AZD0120, a dual CAR T cell therapy targeting CD19 and BCMA, in adults with refractory Systemic Lupus Erythematosus (SLE). This Phase 1b/2, open-label, multi-center clinical trial aims to evaluate the safety, tolerability, and efficacy of this investigational treatment in patients who have not responded to standard therapies. The study is sponsored by AstraZeneca and includes adults aged 18 to 70 with significant SLE-related organ involvement. The study has two parts: Phase 1b focuses on assessing safety and tolerability of AZD0120, while Phase 2 evaluates safety, tolerability, and efficacy at the selected dose from Phase 1b. Participants receive a single infusion of AZD0120 following lymphodepleting chemotherapy using cyclophosphamide and fludarabine. The treatment is delivered as one dose on study day 1 after completing the chemotherapy regimen. Participants will be closely monitored throughout the study, with evaluations including clinical assessments, laboratory tests, and quality of life measures over a two-year period. Researchers will assess the safety, tolerability, efficacy, cellular kinetics, immunogenicity, and presence of replication-competent lentivirus related to AZD0120. The study involves regular visits and follow-up to ensure participant safety and to gather data on treatment effects in refractory SLE.
CONDITIONS
Brief 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 according to federal, local, and institutional guidelines
- Ability and willingness to follow study visit schedule and protocol requirements
- Adequate liver, kidney, lung, and heart function
- Clinical diagnosis of SLE per EULAR/ACR 2019 criteria with positive ANA ≥1:80 and score ≥10
- Prior use of at least two standard immunosuppressants including one biological agent
- SLEDAI-2K score of 6 or higher at screening
- Significant SLE-related organ involvement such as arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, vasculitis, or kidney involvement
- For lupus nephritis: biopsy-confirmed proliferative lupus nephritis (Class III, IV, or V) within 6 months before consent or screening
You will not qualify if you...
- Prior treatment with any CAR T therapy targeting any antigen
- Previous therapies targeting CD19 and/or BCMA
- History of allogenic or autologous stem cell transplant
- Active progressing malignancy or cancer requiring treatment
- Primary immunodeficiency disorders
- Active bacterial or viral infection
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 - Single treatment day with follow-up over 2 years
Participants receive lymphodepleting chemotherapy followed by a single infusion of AZD0120.
1 infusion visit and multiple follow-up visits over 2 years
Duration - Up to 2 years
Participants are monitored for safety, tolerability, efficacy, and cellular kinetics of AZD0120.
Multiple visits over 2 years for assessments
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
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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