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

NCT07087314 | Recruiting Phase 2

• 1 other identifier: CSG-301 SC-204
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nephrotic Syndrome in Children

Outcome Measures

Primary Outcomes (2)

• Incidence and rate of treatment-Emergent Adverse Events

  Number and percentage of adverse events which are calculated by worst CTCAE grade by CTCAE 5.0

  From baseline through study completion, an average of 1 year

• Relapse free survival rate

  Relapse free survival rate at 6 and 12 months

  Average 1 year per subject

Secondary Outcomes (8)

• Relapse frequency in times

  From baseline through study completion, an average of 1 year

• Time to Relapse

  From baseline through study completion, an average of 1 year

• Serum creatinine

  From baseline through study completion, an average of 1 year

• estimated glomerular filtration rate

  From baseline through study completion, an average of 1 year

• Cumulative corticosteroid dose

  From baseline through study completion, an average of 1 year

Study Arms (1)

SG301 Subcutaneous injection

EXPERIMENTAL

full - dose prednisone (60 mg/m²/day, up to 80 mg) for remission induction. After 3 days of negative urine protein, start SG301 Subcutaneous injection with steroid tapering. Taper prednisolone to 60 mg/m² (max 80 mg) every other day, reducing by 1/6 every 2 weeks, and stop after 3 months.

Drug: SG301 Subcutaneous injection

Interventions

SG301 Subcutaneous injection DRUG

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.

SG301 Subcutaneous injection

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mao Jianhua: lead

Study Sites (1)

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

RECRUITING

Central Study Contacts

Yanyan Jin, Doctor

CONTACT

+86 19357612502; jinyanyanzj@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 25, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): July 9, 2028
• Study Completion (Estimated): July 9, 2029
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)