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
- Toronto, CanadaSee the site
- Phase
- Phase 1/2
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 Canada
- TorontoToronto, CanadaNot 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.