A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE

Recruiting now Phase 1/2 NCT06897930

Run by AstraZeneca · for 18 to 70 · All sexes

What this study 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.

Who can join (things the study team will check)

INCLUSION: 1. Males or females aged 18 through 70 years inclusive at the time of consent. 2. Written informed consent in accordance with federal, local, and institutional guidelines. 3. Must be able and willing to adhere to the study visit schedule and other protocol requirements 4. Adequate hepatic, renal, pulmonary, and cardiac function 5. 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. 6. Have used at least two standard immunosuppressants (including one biological agent). 7. SLEDAI-2K score ≥6 at screening. 8. Must include a significant SLE related organ involvement: arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, vasculitis, or renal. 9. 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. EXCLUSION: 1. Have received prior treatment with CAR T therapy directed at any target. 2. Have received any therapy that is targeted to CD19 and/or BCMA 3…

Where this trial is running

Research Site, San Francisco, California, United States
Research Site, Stanford, California, United States
Research Site, Tampa, Florida, United States
Research Site, Atlanta, Georgia, United States
Research Site, Chicago, Illinois, United States
Research Site, Bethesda, Maryland, United States
Research Site, Boston, Massachusetts, United States
Research Site, St Louis, Missouri, United States
Research Site, New York, New York, United States
Research Site, Syracuse, New York, United States
Research Site, Chapel Hill, North Carolina, United States
Research Site, Charlotte, North Carolina, United States

+ 6 more sites.

Who to contact

AstraZeneca Clinical Study Information Center · 1-877-240-9479 · information.center@astrazeneca.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06897930.

Open the interactive checklist for this trial →

Verify everything on the official ClinicalTrials.gov record. Page updated July 2026.

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