Trials Sponsors Conditions Drugs Pricing

Conditions

ANCA-Associated Glomerulonephritis Lupus Nephritis (LN)

Keywords

MSC303Immune 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 MSC303Drug

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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；

Sponsors & Collaborators

Shanghai Changzheng Hospital
Otherlead

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, Shanghai Municipality, 200003, China

Huji Xu, Ph.D, MDCONTACT+862181885516 xuhuji@smmu.edu.cn

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLupus Erythematosus, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune 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 2
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

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

MSC303 Subcutaneous Injection for the Treatment of Immunologic Glomerular Disease.

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

MSC303

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

MSC303

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations