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

A regiszterben nem jelölt feltételek

• 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