NCT05465707

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Keymed Biosciences Co.Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A study of CM313 in subjects with systemic lupus erythematosus

Detailed description

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.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	CM313 2 mg/kg	Once 1 week, intravenous infusion.
BIOLOGICAL	CM313 4 mg/kg	Once 1 week, intravenous infusion.
BIOLOGICAL	CM313 8 mg/kg	Once 1 week, intravenous infusion.
BIOLOGICAL	CM313 16 mg/kg	Once 1 week, intravenous infusion.
BIOLOGICAL	Placebo	Once 1 week, intravenous infusion.

Timeline

• Start date: 2022-10-30
• Primary completion: 2023-10-30
• Completion: 2023-10-30
• First posted: 2022-07-20
• Last updated: 2022-07-20