RecruitingPhase 1NCT06789107

Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus

Clinical Trial of Blinatumomab in Refractory/Active Systemic Lupus Erythematosus in Children


Sponsor

Mao Jianhua

Enrollment

6 participants

Start Date

Dec 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if blinatumomab works to treat refractory or active systemic lupus erythematosus (SLE) in children and adults. It will also learn about the safety of blinatumomab. The main questions it aims to answer are: Does blinatumomab improve symptoms and disease activity in refractory/active SLE? What side effects or adverse events do participants experience when taking blinatumomab? Participants will: Receive two courses of blinatumomab injections over five consecutive days each Be monitored for 52 weeks to evaluate the treatment's safety and effectiveness Undergo regular blood tests and assessments of disease activity during follow-up visits Researchers will collect data on changes in serological markers, disease symptoms, and adverse events throughout the study.


Eligibility

Min Age: 5 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Blinatumomab 9ug for people with blinatumomab, children, and other related conditions. The study is currently recruiting participants at 2 locations.

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 9ug

Blinatumomab for Refractory/Active Systemic Lupus Erythematosus. 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(2)

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT06789107


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