MSC303 Subcutaneous Injection for the Treatment of Immunologic Glomerular Disease.

NCT ID: NCT07000292

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-20
• Study Completion Date: 2027-02-20

Brief Summary

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

Detailed Description

The primary endpoint of Phase Ib：Evaluate the safety of MSC303 in patients with Lupus Nephritis (LN）and ANCA-associated glomerulonephritis (ANCA-GN).

The primary endpoint of Phase II：Evaluate the change of Urine Protein/Creatinine Ratio (UPCR) in Week 12 compared with the baseline of MSC303 in patients with Lupus Nephritis(LN） and ANCA-associated glomerulonephritis (ANCA-GN).

Conditions

Lupus Nephritis (LN); ANCA-Associated Glomerulonephritis

Study Design

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

Study Groups

MSC303

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.

Group Type: EXPERIMENTAL

Injection of MSC303

Intervention Type: 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.

Interventions

Injection of MSC303

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Aged 18 to 65 years (including boundary values), gender unspecified；

2. Willing to participate voluntarily in this clinical study and with good compliance；

3. Regarding the criteria for the study diseases, meet the diagnostic criteria for any of the following diseases:

1. Diagnosed with lupus nephritis(LN);

2. diagnosed with ANCA-associated glomerulonephritis (ANCA-GN);

4. Sufficient organ function;

Exclusion Criteria

1. History of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of MSC303；

2. Active infection requiring antibiotic treatment；

3. Concomitant with other serious diseases；

4. Patients with congenital immunoglobulin deficiency；

5. 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 ));

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Changzheng Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xu huji

Professor and Chief Physician, Head of the Department of Rheumatology and Immunology, Shanghai Changzheng Hospital.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huji Xu, Ph.D, MD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Changzheng Hospital

Locations

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Huji Xu, Ph.D, MD

Role: CONTACT

xuhuji@smmu.edu.cn

+862181885516

Facility Contacts

Huji Xu, Ph.D, MD

Role: primary

xuhuji@smmu.edu.cn

+862181885516

Other Identifiers

MSC303-CT201

Identifier Type: -

Identifier Source: org_study_id