SG301 (anti-CD38) injection for children with frequently relapsing or steroid-dependent nephrotic syndrome

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

This Phase 2 trial will test whether SG301 (an anti-CD38 antibody) injections are safe and help children aged 6–18 who have frequently relapsing or steroid‑dependent nephrotic syndrome.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 6 Years to 18 Years
• Sex: All
• Sponsor: The Children's Hospital of Zhejiang University School of Medicine (Academic / other)
• Drugs / interventions: belimumab, rituximab, obinutuzumab, cyclophosphamide
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07087314 on ClinicalTrials.gov

What this trial studies

This open-label Phase 2 study enrolls children aged 6–18 with steroid-sensitive nephrotic syndrome who have frequent relapses or steroid dependence and are in protein remission after steroid treatment. Recruitment begins with the 12–18 age group and will expand to the 6–12 group after interim safety and pharmacology reviews, with phased data review for each 1–3 participants. Participants receive subcutaneous SG301 at 10 mg/kg with weekly injections for six weeks then every two weeks for three doses (nine total injections) during a 12-week treatment period, followed by a 40-week follow-up. The trial focuses on safety, pharmacokinetics, pharmacodynamics, and preliminary signs of reduced relapse or steroid need.

Who should consider this trial

Good fit: Children 6–18 years old with steroid-sensitive nephrotic syndrome who have frequent relapses or steroid dependence, normal renal function, documented low urine protein after steroid treatment, and no recent excluded immunosuppressive or B‑cell depleting therapies are ideal candidates.

Not a fit: Children with familial nephrotic syndrome, chronic glomerulonephritis or uremia history, significant liver enzyme elevation, active high‑burden hepatitis B infection, impaired renal function, or recent rituximab/other excluded drugs are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, SG301 could lower relapse frequency and reduce reliance on steroids and other long‑term immunosuppressants in affected children.

How similar studies have performed: Early case reports and small series of anti‑CD38 antibodies in refractory proteinuric kidney diseases have shown some promise, but robust controlled pediatric data are limited.

Eligibility criteria

Inclusion Criteria:

1. Aged 6 - 18 years.
2. Steroid-sensitive nephrotic syndrome with frequent relapses (FRNS) or steroid dependence (SDNS).
3. Normal renal function: eGFR≥90 ml/min/1.73m².
4. After steroid treatment, morning urine protein\<1 + or urine protein/creatinine\<0.2 g/g (\<20 mg/mmol) for ≥3 consecutive days.
5. 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.
6. Prothrombin time/INR≤1.5×ULN, unless due to anticoagulation.
7. No Tacrolimus, cyclosporine A, mycophenolate mofetil, belimumab, levamisole, azathioprine, or cyclophosphamide in prior 2 months; no rituximab or obinutuzumab in prior 6 months.

Exclusion Criteria:

1. Family history of nephrotic syndrome, chronic glomerulonephritis, or uremia.
2. Alanine aminotransferase \>2×ULN or total bilirubin\>2×ULN with a sustained increase for 2 weeks.
3. 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.
4. Chronic active infections (e.g., Epstein-Barr Virus, Cytomegalovirus, tuberculosis) that may worsen with steroids/ immunosuppressants.
5. Acute active infection (excluding onychomycosis) requiring systemic antibiotics/antivirals.
6. Secondary nephrotic syndrome (e.g.,immunoglobulin A - associated, lupus nephritis); steroid - resistant nephrotic syndrome (SRNS).
7. Other autoimmune diseases, primary immunodeficiency, or malignancy.
8. Prior anti - cluster of differentiation 38 (CD38) treatment.
9. Live/attenuated vaccine receipt or major surgery (non - diagnostic) within 4 weeks before first dose.

Where this trial is running

Hangzhou, Zhejiang

• Children's Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Yanyan Jin, Doctor

Conditions Nephrotic Syndrome in Children