Toczeń: badanie fazy I leku CLN-978

Kryteria wyłączenia kto nie może wziąć udziału (16)

1. Active inflammatory disease other than SLE. Thyroiditis or secondary Sjogren's syndrome is allowed.
2. Considered at high risk for thrombosis.
3. Rapidly progressive glomerulonephritis, and/or urine protein/creatinine >3 mg/mg (339 mg/mmol).
4. Active severe neuropsychiatric/CNS manifestations of SLE.
5. Evidence of hepatitis B, hepatitis C (HCV) infection, human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection.
6. History of splenectomy.
7. Prior treatment with the following:
8. Cellular or gene therapy product directed at any target.
9. Investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to Day 1.
10. Any anti-CD19 or anti-CD20 therapy less than 3 months prior to Day 1.
11. Non-biologic DMARD within 14 days prior to Day 1.
12. Cyclophosphamide within 1 month or a biologic immunomodulating therapy during 2 months prior to Day 1.
13. Live or attenuated vaccine within 28 days prior to screening or during screening.
14. Active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including SARS-CoV-2 infection, within 14 days before Day 1.
15. 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.
16. 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.