MSC303 Subcutaneous Injection for the Treatment of Immunologic Glomerular Disease.

NCT07000292 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: MSC303-CT201
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the safety and efficacy of MSC303 in patients with Immune glomerular diseases.

Conditions

Lupus Nephritis (LN); ANCA-Associated Glomerulonephritis

Keywords

MSC303; Immune glomerular diseases

Outcome Measures

Primary Outcomes (1)

• Phase Ib: safety Phase II: Urine Protein/Creatinine Ratio (UPCR)

  Phase Ib: To evaluate the safety of MSC303 for injection in subjects with immune glomerular diseases. Phase II: To evaluate the change in Urine Protein/Creatinine Ratio (UPCR) from baseline at Week 12.

  12 week

Study Arms (1)

MSC303

EXPERIMENTAL

MSC303 is an asymmetric trivalent bispecific antibody targeting both CD20 and CD3 (with a ratio of CD20:CD3 at 2:1). By binding to the CD20 antigen on the surface of B cells with one end and the CD3 on the surface of T cells with the other, MSC303 recruits activated T cells around B cells, thereby enhancing the killing effect on B cells.

Drug: Injection of MSC303

Interventions

Injection of MSC303 DRUG

Dose Group 1: D1, D8, D15, and D36 were respectively given 1, 5, 15, and 15 mg of MSC303 for injection; The second dose group: D1, D8, D15 and D36 were respectively given for injection MSC303 1, 5, 20, 20 mg.

MSC303

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 65 years (including boundary values), gender unspecified；
• Willing to participate voluntarily in this clinical study and with good compliance；
• Regarding the criteria for the study diseases, meet the diagnostic criteria for any of the following diseases:
• Diagnosed with lupus nephritis(LN);
• diagnosed with ANCA-associated glomerulonephritis (ANCA-GN);
• Sufficient organ function;

You may not qualify if:

• History of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of MSC303；
• Active infection requiring antibiotic treatment；
• Concomitant with other serious diseases；
• Patients with congenital immunoglobulin deficiency；
• Infection with human immunodeficiency virus (Human immunodeficiency virus (HIV)), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal Hepatitis B Virus DNA (HBV DNA) or Hepatitis C virus RNA (HCV RNA ));

Sponsors & Collaborators

• Shanghai Changzheng Hospital: lead

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

Location

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Huji Xu, Ph.D, MD

  Shanghai Changzheng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huji Xu, Ph.D, MD

CONTACT

+862181885516; xuhuji@smmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Physician, Head of the Department of Rheumatology and Immunology, Shanghai Changzheng Hospital.

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 2, 2025
• Study Start: June 20, 2025
• Primary Completion (Estimated): May 20, 2026
• Study Completion (Estimated): February 20, 2027
• Last Updated: June 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)