drugset / Trial / NCT06607991

Blinatumomab for CNI-Resistant/Intolerant SRNS in Children

NCT06607991

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-09-19
Primary completion
2026-09-19
Completion
2027-09-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Blinatumomab Monoclonal antibody 5 ug/m2 Intravenous