Clinical Trial

Blinatumomab for CNI-Resistant/Intolerant SRNS in Children

Recruiting Phase 1
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-09-19; most recent amendment 2025-08-03.
Trial Details
NCT Number NCT06607991
Lead Sponsor The Children's Hospital of Zhejiang University School of Medicine
Conditions CNI-resistant Steriod Resistant Nephrotic Syndrome, CNI-intolerent, Steriod Resistant Nephrotic Syndrome, Multidrug Resistant Nephrotic Syndrome
Enrollment 6 participants
Start Date 2024-09-19
Primary Completion 2026-09-19 (estimated)
Study Completion 2027-09-18 (estimated)
Updated on ClinicalTrials.gov 2025-08-06