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This study will evaluate the safety and efficacy of MSC303 in patients with Immune glomerular diseases.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Aged 18 to 65 years (including boundary values), gender unspecifiedï¼›
Willing to participate voluntarily in this clinical study and with good complianceï¼›
Regarding the criteria for the study diseases, meet the diagnostic criteria for any of the following diseases:
Sufficient organ function;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huji Xu, Ph.D, MD | Contact | +862181885516 | xuhuji@smmu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Huji Xu, Ph.D, MD | Shanghai Changzheng Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Changzheng Hospital | Shanghai | Shanghai Municipality | 200003 | China |
Due to concerns regarding the security of patient personal information.
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| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |