NCT06607991 Blinatumomab for CNI-Resistant/Intolerant SRNS in Children
| NCT ID | NCT06607991 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | The Children's Hospital of Zhejiang University School of Medicine |
| Condition | CNI-resistant Steriod Resistant Nephrotic Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 6 participants |
| Start Date | 2024-09-19 |
| Primary Completion | 2026-09-19 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 6 participants in total. It began in 2024-09-19 with a primary completion date of 2026-09-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This exploratory clinical trial aims to evaluate the efficacy and safety of Blinatumomab in treating children with calcineurin inhibitor (CNI)-resistant or multidrug-resistant steroid-resistant nephrotic syndrome (SRNS). Eligible participants include pediatric patients aged 2 to 17 years who have either failed to respond to adequate CNI therapy or are resistant to at least two classes of immunosuppressants, including CNIs and biologics. A short course of low-dose Blinatumomab will be administered in an open-label, single-arm, self-controlled trial design. The study seeks to determine whether Blinatumomab can reduce proteinuria and induce clinical remission in this difficult-to-treat population, offering a potential new therapeutic option for children with limited response to conventional therapies.
Eligibility Criteria
\- Inclusion Criteria: Subjects must meet all of the following criteria to be included in the study: 1.Age between 2 and 17 years, regardless of gender. 2.Meet the 2021 KDIGO definition of steroid-resistant nephrotic syndrome (SRNS), and fulfill either of the following: 1. Have received an adequate dose of calcineurin inhibitors (CNIs) for more than 6 months without achieving at least partial remission. 2. Or have contraindications to CNI use, including: 1\) Significant renal impairment, defined as estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m², or presence of acute kidney injury at the time of diagnosis; 2) Renal biopsy showing prominent acute or chronic tubular injury, such as tubular atrophy or interstitial fibrosis involving more than 50% of the sampled tissue; 3) Elevated urinary markers (β2-microglobulin, α1-microglobulin, or retinol-binding protein) exceeding three times the upper limit of normal; 4) Abnormal glucose tolerance; 5) Severe uncontrolled hypertension, defined as systolic and/or diastolic blood pressure ≥ the 95th percentile + 12 mmHg for age, sex, and height, or ≥ 140/90 mmHg; 6) Concomitant use of medications known to have significant interactions with CNIs, leading to increased toxicity or reduced efficacy; 7) Known allergy or hypersensitivity to CNIs or any of their components. (3) Or have demonstrated inadequate response or disease relapse after treatment with at least two immunosuppressive agents, including CNIs and at least one of the following: 1. Conventional immunosuppressive agents: cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide 2. Biologic agents: abatacept, ofatumumab, obinutuzumab, rituximab Inadequate response is defined as failure to achieve complete remission after 12 months of therapy or relapse following initial response. 3\. Renal biopsy performed prior to screening confirms a diagnosis of minimal change disease (MCD) or focal segmental glomerulosclerosis (FSGS). 4\. The subject and/or their legal guardian must provide written informed consent, indicating understanding of the study's purpose and procedures, with the right to withdraw consent at any time without affecting the subject's future medical care. -Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from the study: 1. eGFR \< 60 mL/min/1.73 m² (using the modified Bedside Schwartz formula); 2. Stroke or seizure within 6 months prior to screening, or other active central nervous system disorders; 3. Genetic nephropathy confirmed by genetic testing; 4. Renal biopsy confirming IgA nephropathy, membranous nephropathy, or membranoproliferative glomerulonephritis; 5. Severe congenital heart disease or history of acute myocardial infarction within 6 months, or severe arrhythmias (e.g., frequent multifocal ventricular or supraventricular tachycardia, ventricular tachycardia), or moderate to large pericardial effusion, severe myocarditis, or unstable vital signs requiring vasopressors to maintain blood pressure; 6. Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with hepatitis B virus (HBV) DNA levels above the normal range; positive for hepatitis C virus (HCV) antibodies with HCV RNA levels above the normal range; or positive for human immunodeficiency virus (HIV) antibodies, syphilis, or cytomegalovirus (CMV) DNA; 7. Abnormal laboratory values prior to screening: moderate to severe neutropenia (≤1.0×10⁹/L); moderate to severe anemia (hemoglobin ≤90 g/L); thrombocytopenia (≤75×10⁹/L); or liver dysfunction (ALT, AST, or bilirubin greater than 2.5 times the upper limit of normal and persisting for 2 weeks); 8. Subjects with tumors or other life-threatening diseases prior to screening; 9. Positive blood pregnancy test; 10. Participation in other clinical trials within 1 month prior to enrollment; 11. Received rituximab or cyclophosphamide therapy within the past 3 months; 12. Any other condition deemed by the investigator to be unsuitable for participation; 13. Vaccination with live vaccines within 4 weeks prior to screening.
Contact & Investigator
Jianhua Mao, PhD, MD
PRINCIPAL INVESTIGATOR
Children's Hospital, Zhejiang University School of Medicine
Frequently Asked Questions
Who can join the NCT06607991 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 17 Years, studying CNI-resistant Steriod Resistant Nephrotic Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06607991 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06607991 currently recruiting?
Yes, NCT06607991 is actively recruiting participants. Contact the research team at maojh88@zju.edu.cn for enrollment information.
Where is the NCT06607991 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06607991 clinical trial?
NCT06607991 is sponsored by The Children's Hospital of Zhejiang University School of Medicine. The principal investigator is Jianhua Mao, PhD, MD at Children's Hospital, Zhejiang University School of Medicine. The trial plans to enroll 6 participants.