NCT07000292Not yet recruitingPhase 1/2
MSC303 Subcutaneous Injection for the Treatment of Immunologic Glomerular Disease.
A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics and Efficacy of Subcutaneous Injection of MSC303 for the Treatment of Immune Glomerular Diseases
Source: ClinicalTrials.gov · Last updated 11 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study will evaluate the safety and efficacy of MSC303 in patients with Immune glomerular diseases.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 29 May 2025
- Start date
- 20 Jun 2025
- Primary completion date
- 20 May 2026
- Lead sponsor
- Shanghai Changzheng Hospital
- Diseases
- Lupus (SLE)
- NCT number
- NCT07000292
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 12
- From 20 Jun 2025 to the primary completion date, 20 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant with other serious diseases；
Other illness
- History of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of MSC303；
- Active infection requiring antibiotic treatment；
- 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
- Patients with congenital immunoglobulin deficiency；
- Other exclusion criteria may apply.
Who the study is looking for
- 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;
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Changzheng Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.