Tests AZD0120 cell therapy in adults with hard-to-treat lupus
Tests AZD0120, a CAR T cell treatment, in adults with lupus.
Plain-language title generated from the registry record
Registry title: A Study to Investigate the Safety, Tolerability, and Efficacy of AZD0120 in Adults With Refractory SLE
Key facts
- Where
- Darlinghurst and Melbourne, AustraliaSee the 2 sites
- Phase
- Phase 1/2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with systemic lupus erythematosus (SLE) that has not improved with earlier treatments. They will receive AZD0120, a CAR T cell therapy.
- Age
- 18 to 70 years
- Sex
- Men and women
- Disease stage
- SLE diagnosed by EULAR/ACR 2019 criteria with positive ANA ≥1:80 and a score ≥10. SLEDAI-2K score ≥6 at screening. Significant organ involvement such as arthritis, myositis, rash, alopecia, mucosal ulcers, pleurisy, pericarditis, vasculitis or kidney. If lupus nephritis: proliferative disease, Class III, IV or V, shown by a kidney biopsy.
- Earlier treatment
- Must have used at least two standard immunosuppressants, including one biological agent. Must not have had CAR T therapy, therapy aimed at CD19 or BCMA, or a stem cell transplant.
- Biomarker or test result
- Positive ANA ≥1:80.
Main reasons for not taking part
- Earlier CAR T therapy
- Earlier therapy aimed at CD19 and/or BCMA
- Earlier stem cell transplant (allogenic or autologous)
- Active cancer that is growing or needs treatment
- Primary immunodeficiency or active viral or bacterial infection
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06897930, who can take part
Where in Australia
- DarlinghurstDarlinghurst, AustraliaTaking people
- MelbourneMelbourne, AustraliaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT06897930
- Record updated
- 10 September 2026
- Original description
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.Read full original descriptionShow less
A Phase 1b/2 Study of AZD0120, a Chimeric Antigen Receptor T-cell (CAR T) Therapy Targeting CD19 and B-cell Maturation Antigen (BCMA) in Subjects With Refractory Systemic Lupus Erythematosus (SLE)
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.
INCLUSION:; 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; EXCLUSION:; 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.