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

Inclusion Criteria

• •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. Received allogenic stem cell transplant or autologous stem cell transplant.
• •4. An active malignancy that is progressing or requires active treatment.
• •5. Primary immunodeficiency
• •6. Active viral or bacterial infection