A Study of CM313 Injection in Subjects With Systemic Lupus Erythematosus

Keymed Biosciences Co.Ltd40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Systemic Lupus Erythematosus

Interventions

CM313 2 mg/kgBIOLOGICAL

Once 1 week, intravenous infusion.

CM313 4 mg/kgBIOLOGICAL

Once 1 week, intravenous infusion.

CM313 8 mg/kgBIOLOGICAL

Once 1 week, intravenous infusion.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of treatment-emergent adverse events (TEAEs).

Safety parameters

Time frame: Baseline up to Day 113

Data from ClinicalTrials.gov

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