A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus

A Randomized, Double-blind, Placebo-controlled, Dose-escalation, Multiple-dose Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of CM313 Injection in Subjects With Systemic Lupus Erythematosus

A study of CM313 in subjects with systemic lupus erythematosus

This is a multi-center, randomed, open-label, dose escalation and dose expansion, Phase 1 study to evaluate the safety, tolerability, Pharmacokinetics and preliminary anti-tumor activity.

About 40 patients who meet eligibility criteria will be randomized 4:1 to receive either CM313 or matched placebo, intravenous infusion.

The treatment period includes single dosing and multiple dosing period, in which CM313 and placebo will be adminitrated intravenously, once every 1 week.

Inclusion Criteria:

• 18 years old ≤ age ≤ 65 years old.
• Positive autoantibody serology test at screening.
• Contraception.
• Voluntarily sign the ICF.

Exclusion Criteria:

• With central nervous system disease caused by or not caused by SLE within 8 weeks before the first dose of study drug.
• Possibly active Mycobacterium tuberculosis infection.
• With the history of vital organ transplantation or hematopoietic stem cell/or bone marrow transplantation.
• Heavy drinking in the 3 months prior to screening.
• With depression or suicidal thoughts.