A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus

Phase 1

• Conditions: Systemic Lupus Erythematosus
• Interventions: Biological: CM313 8 mg/kg; Biological: CM313 2 mg/kg; Biological: CM313 16 mg/kg; Biological: CM313 4 mg/kg; Biological: Placebo

• 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.

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-07-07
• Study First Submitted QC: 2022-07-19
• Last Update Submitted: 2022-07-19
• Study First Posted: 2022-07-20
• Last Update Posted: 2022-07-20
• Study Start: 2022-10-30
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30

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

Arm && Interventions

Group	Intervention	Description
CM313 8 mg/kg	CM313 8 mg/kg	Once 1 week, intravenous infusion.
CM313 2 mg/kg	CM313 2 mg/kg	Once 1 week, intravenous infusion.
CM313 16 mg/kg	CM313 16 mg/kg	Once 1 week, intravenous infusion.
CM313 4 mg/kg	CM313 4 mg/kg	Once 1 week, intravenous infusion.
Placebo	Placebo	Once 1 week, intravenous infusion.

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events (TEAEs).	Baseline up to Day 113	Safety parameters