NCT07087314

A Study of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Nephrotic Syndrome With Frequent Relapses or Steroid Dependence

A Clinical Study to Evaluate the Initial Efficacy and Safety of Anti-CD38 Monoclonal Antibody (SG301) Subcutaneous Injection in Children With Frequent Relapses or Steroid-Dependent Nephrotic Syndrome

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Mao Jianhua · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open - label study to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of SG301 Subcutaneous injection in children with frequently relapsing or steroid - dependent nephrotic syndrome.

Detailed description

This study will recruit children aged 6 - 18 with frequently relapsing or steroid - dependent nephrotic syndrome, who have morning urine protein \< 1 + or urine protein / creatinine \< 0.2 g/g (\<20 mg/mmol) for at least three consecutive days after steroid treatment. The study will stratify participants into two age groups:≥6 - \<12 years and≥12 - \<18 years. Recruitment will start with the 12 - 18 - year - old group. After collecting sufficient safety and clinical pharmacology data to support moving to lower age groups, the 6 - 12 - year - old group will be recruited. For every 1 to 3 participants enrolled, there will be a phased data review to guide further recruitment. The trial has three phases: screening (D - 28\~D - 1), treatment (12 - week), and follow - up (40 - week). The enrolled participants will be treated with 10 mg/kg SG301 Subcutaneous injection subcutaneously. They will receive weekly injections for the first six weeks, then every two weeks for three times, totaling nine injections.

Conditions

• Nephrotic Syndrome in Children

Interventions

Type	Name	Description
DRUG	SG301 Subcutaneous injection	Subcutaneous injection every weeks (QW\*6),subsequently, administer it once every two weeks for a total of three times (Q2W\*3). The total number of doses is nine.

Timeline

• Start date: 2025-08-25
• Primary completion: 2028-07-09
• Completion: 2029-07-09
• First posted: 2025-07-25
• Last updated: 2026-02-27

Locations

1 site across 1 country: China