RecruitingPhase 1NCT06607991

Blinatumomab for CNI-Resistant/Intolerant SRNS in Children

Study of Blinatumomab for the Treatment of Calcineurin Inhibitor-Resistant or Intolerant Steriod-Resistant Nephrotic Syndrome in Pediatric Patients


Sponsor

The Children's Hospital of Zhejiang University School of Medicine

Enrollment

6 participants

Start Date

Sep 19, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Blinatumomab Treatment for people with cni-intolerent, cni-resistant steriod resistant nephrotic syndrome, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 2 Years to 17 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBlinatumomab Treatment

Blinatumomab treatment for CNI-resistant/Intolerant pediatric steriod-resistant nephrotic syndrome Patients will receive two 5-day cycles of Blinatumomab (5 µg/m²/day, maximum dose 9 µg/day), administered intravenously. The second cycle will begin on the first day of the third week following the first cycle.


Locations(1)

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT06607991