Status:
NOT_YET_RECRUITING
MSC303 Subcutaneous Injection for the Treatment of Immunologic Glomerular Disease.
Lead Sponsor:
Shanghai Changzheng Hospital
Conditions:
Lupus Nephritis (LN)
ANCA-Associated Glomerulonephritis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 cha...
Eligibility Criteria
Inclusion
- 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;
Exclusion
- 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 ));
- Other exclusion criteria may apply.
Key Trial Info
Start Date :
June 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 20 2027
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07000292
Start Date
June 20 2025
End Date
February 20 2027
Last Update
June 11 2025
Active Locations (1)
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1
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200003