A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05465707
• Other study ID #: CM313-106001
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: October 30, 2022
• Est. completion date: October 30, 2023

Study information

• Verified date: July 2022
• Source: Keymed Biosciences Co.Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A study of CM313 in subjects with systemic lupus erythematosus

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: October 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Biological:
• CM313 2 mg/kg
Once 1 week, intravenous infusion.
• CM313 4 mg/kg
Once 1 week, intravenous infusion.
• CM313 8 mg/kg
Once 1 week, intravenous infusion.
• CM313 16 mg/kg
Once 1 week, intravenous infusion.
• Placebo
Once 1 week, intravenous infusion.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Keymed Biosciences Co.Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of treatment-emergent adverse events (TEAEs).	Safety parameters	Baseline up to Day 113