MedPath

A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus

Phase 1
Conditions
Systemic Lupus Erythematosus
Registration Number
NCT05465707
Lead Sponsor
Keymed Biosciences Co.Ltd
Brief 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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
40
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Incidence of treatment-emergent adverse events (TEAEs).Baseline up to Day 113

Safety parameters

Secondary Outcome Measures
NameTimeMethod

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.