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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Incidence and rate of treatment-Emergent Adverse Events [Срок оценки: From baseline through study completion, an average of 1 year]
• Relapse free survival rate [Срок оценки: Average 1 year per subject]

Вторичные конечные точки (8)

• Relapse frequency in times [Срок оценки: From baseline through study completion, an average of 1 year]
• Time to Relapse [Срок оценки: From baseline through study completion, an average of 1 year]
• Serum creatinine [Срок оценки: From baseline through study completion, an average of 1 year]
• estimated glomerular filtration rate [Срок оценки: From baseline through study completion, an average of 1 year]
• Cumulative corticosteroid dose [Срок оценки: From baseline through study completion, an average of 1 year]
• SG301 anti-drug antibodies [Срок оценки: From baseline through study completion, an average of 1 year]
• Neutralizing antibodies against SG301 [Срок оценки: From baseline through study completion, an average of 1 year]
• pharmacokinetics : Ctrough [Срок оценки: From baseline through study completion, an average of 1 year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Children's Hospital, Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07087314 · CSG-301 SC-204

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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