A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus

Exclusion Criteria

• •Active inflammatory disease other than SLE. Thyroiditis or secondary Sjogren's syndrome is allowed.
• •Considered at high risk for thrombosis.
• •Rapidly progressive glomerulonephritis, and/or urine protein/creatinine \>3 mg/mg (339 mg/mmol).
• •Active severe neuropsychiatric/CNS manifestations of SLE.
• •Evidence of hepatitis B, hepatitis C (HCV) infection, human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection.
• •History of splenectomy.
• •Prior treatment with the following:
• •* Cellular or gene therapy product directed at any target.
• •* Investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day 1.
• •* Any anti-CD19 or anti-CD20 therapy less than 3 months prior to Day 1.
• •* Non-biologic DMARD within 14 days prior to Day 1.
• •* Cyclophosphamide within 1 month or a biologic immunomodulating therapy during 2 months prior to Day 1.
• •Live or attenuated vaccine within 28 days prior to screening or during screening.
• •Active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including SARS-CoV-2 infection, within 14 days before Day 1.
• •Active or latent tuberculosis (TB) evidenced by a positive or indeterminant Interferon Gamma Release Assay (IGRA), unless the patient has documented previous completion of TB treatment and no current clinical indication of TB.
• •Any condition for which, in the opinion of the Investigator and/or Sponsor, would not be in the best interest of the patient to participate in the study or that could prevent, limit, or confound any protocol-defined assessment.