RecruitingPhase 2NCT07087314

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

Sponsor

Mao Jianhua

Enrollment

30 participants

Start Date

Aug 25, 2025

Study Type

INTERVENTIONAL

Conditions

Nephrotic Syndrome in Children

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.

Eligibility

Min Age: 6 YearsMax Age: 18 Years

Inclusion Criteria7

Aged 6 - 18 years.
Steroid-sensitive nephrotic syndrome with frequent relapses (FRNS) or steroid dependence (SDNS).
Normal renal function: eGFR≥90 ml/min/1.73m².
After steroid treatment, morning urine protein\<1 + or urine protein/creatinine\<0.2 g/g (\<20 mg/mmol) for ≥3 consecutive days.
Within 7 days before enrollment, blood tests (without growth factors or transfusions) must meet: hemoglobin\>80 g/L; platelets\>75×10⁹/L; neutrophils\>1.5×10⁹/L.
Prothrombin time/INR≤1.5×ULN, unless due to anticoagulation.
No Tacrolimus, cyclosporine A, mycophenolate mofetil, belimumab, levamisole, azathioprine, or cyclophosphamide in prior 2 months; no rituximab or obinutuzumab in prior 6 months.

Exclusion Criteria9

Family history of nephrotic syndrome, chronic glomerulonephritis, or uremia.
Alanine aminotransferase \>2×ULN or total bilirubin\>2×ULN with a sustained increase for 2 weeks.
HBsAg or HBcAb positive with Hepatitis B virus DNA above the lower limit of normal; Hepatitis C virus antibody - positive with Hepatitis C virus RNA positive; HIV antibody - positive.
Chronic active infections (e.g., Epstein-Barr Virus, Cytomegalovirus, tuberculosis) that may worsen with steroids/ immunosuppressants.
Acute active infection (excluding onychomycosis) requiring systemic antibiotics/antivirals.
Secondary nephrotic syndrome (e.g.,immunoglobulin A - associated, lupus nephritis); steroid - resistant nephrotic syndrome (SRNS).
Other autoimmune diseases, primary immunodeficiency, or malignancy.
Prior anti - cluster of differentiation 38 (CD38) treatment.
Live/attenuated vaccine receipt or major surgery (non - diagnostic) within 4 weeks before first dose.

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Interventions

DRUGSG301 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.