Clinical Study of Cizutamig in Systemic Lupus Erythematosus

Prior treatment

• Receipt of or inability to discontinue any excluded therapies
• Receipt of live vaccine within 4 weeks prior to Screening
• Presence of any concomitant autoimmune disease
• APS or thrombotic event not adequately controlled by anticoagulation therapy
• Presence of 1 or more significant concurrent medical conditions
• Major surgery requiring use of general anesthesia within 12 weeks or planned or expected major surgery during the study

Other illness

• Active infection
• Active or known history of catastrophic anti-phospholipid syndrome (APS)
• History of progressive multifocal leukoencephalopathy
• History of primary immunodeficiency or a hereditary deficiency of the complement system
• Central nervous system disease
• Have a diagnosis or history of malignant disease within 5 years
• Serious mental illness, alcohol or drug abuse, dementia, or any other condition that would impair the patient's ability to receive the planned treatment or to understand informed consent at the study site as determined by local practice
• History of severe allergic or anaphylactic reactions to mAb therapy (or recombinant antibody-related fusion proteins) or any constituents of cizutamig
• History of or planned organ transplant and/or autologous or allogeneic hematopoietic stem cell transplantation

Lab values

• Inadequate clinical laboratory parameters at Screening

Other

• Inability to comply with protocol-mandated requirements
• Women who are pregnant or breastfeeding
• Patients who do not agree to the use of highly effective contraception as defined by the protocol
• Individuals considered to be part of a vulnerable population (eg, incarceration)

• 18 to 75 years old at the time of signing the informed consent form
• Diagnosis of SLE according to the ACR/EULAR classification criteria
• Positive anti-dsDNA or positive anti-Smith antibodies AND positive for at least one other of anti-dsDNA, anti-Smith antibodies, or ANA ≥1:80 at screening
• SLEDAI-2K total score ≥6 and SLEDAI-2K clinical score≥4 at Screening
• The investigator judged that the patient had an inadequate response to prior treatment for at least 3 months before screening
• Stable use of concomitant therapies
• For patients with active LN only: LN Class III or IV