Study of CM355 in Patients With Systemic Lupus Erythematosus

NCT ID: NCT07104344

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-25
• Study Completion Date: 2026-10-31

Brief Summary

This study was designed to investigate the safety and efficacy of CM355 in patients with refractory SLE.

Detailed Description

This study is designed to investigate the safety and efficacy of CM355 in patients with moderately to severely active SLE who are refractory to treatment, and to analyze its pharmacokinetic profile , pharmacodynamic effects, and immunogenicity.

Conditions

Systemic Lupus Erythematosus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CM355

Group Type: EXPERIMENTAL

CM355

Intervention Type: BIOLOGICAL

CM355 injection

Interventions

CM355

CM355 injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Ability to understand the nature of the study and voluntarily sign the informed consent form (ICF);
• Age ≥ 18 to ≤ 65 years old, male or female;
• At screening, patients must meet the 2019 European League Against Rheumatism (EULAR)/ American college of Rheumatology (ACR)classification criteria for systemic lupus erythematosus (SLE) as assessed by a qualified doctor, and have a disease course of ≥ 12 months；
• systemic lupus erythematosus disease activity index2000 (SLEDAI-2K)≥8 points at screening. If there is a low complement and/or anti-ds-DNA antibody score, the SLEDAI-2K) clinical symptoms (excluding low complement and/or anti-ds-DNA antibody) score ≥ 6 points or ≥ 1 organ system in BILAG score should be Class A at screening；
• Definition of refractory SLE;
• The treatment regimen for SLE was stable for more than 4 weeks before the first dose.

Exclusion Criteria

• Renal disease: patients with severe lupus nephritis;
• Patients with central nervous system diseases;
• Patients who have received monoclonal antibodies targeting Cluster of Differentiation 19(CD19) or Cluster of Differentiation 20(CD20) or other B-cell depleting agents within 6months prior to the first dose ;
• Any other condition assessed by investigator as unsuitable for participation in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hai Long

Role: PRINCIPAL_INVESTIGATOR

Second Xiangya Hospital of Central South University

Locations

Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Countries

China

Central Contacts

Qianjin Lu

Role: CONTACT

qianlu5860@pumcderm.cams.cn

+86 13787097676

Facility Contacts

Qianjin Lu

Role: primary

qianlu5860@pumcderm.cams.cn

+86 13787097676

Other Identifiers

CM355_SLE_IIT

Identifier Type: -

Identifier Source: org_study_id