Not Yet RecruitingPhase 1/2

MSC303 Subcutaneous Injection for the Treatment of Immunologic Glomerular Disease.

China12 participantsStarted 2025-06-20

Plain-language summary

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

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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;

✕. 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.

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

Timeframe: 12 week

NCT IDNCT07000292

SponsorShanghai Changzheng Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05-20

Huji Xu, Ph.D, MD