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

NCT ID: NCT07087314

Last Updated: 2025-09-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-25
• Study Completion Date: 2029-07-09

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.

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 12 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SG301 Subcutaneous injection

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.

Group Type: EXPERIMENTAL

SG301 Subcutaneous injection

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mao Jianhua

OTHER

Sponsor Role: lead

Responsible Party

Mao Jianhua

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Henan Children's Hospital Zhengzhou Children's Hospital

Zhengzhou, Henan, China

Site Status: NOT_YET_RECRUITING

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, China

Site Status: NOT_YET_RECRUITING

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yanyan Jin, Doctor

Role: CONTACT

jinyanyanzj@163.com

+86 19357612502

Facility Contacts

Cuihua Liu, Master

Role: primary

Liru Qiu, Doctor

Role: primary

Jianhua Mao, Docter

Role: primary

Other Identifiers

CSG-301 SC-204

Identifier Type: -

Identifier Source: org_study_id