Clinical Trial

Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus

Study acronym: BRASLE
Recruiting Phase 1
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-01-17; most recent amendment 2025-11-22.
Trial Details
NCT Number NCT06789107
Lead Sponsor Mao Jianhua
Conditions Systemic Lupus Erythematosus (SLE), Children, Blinatumomab
Enrollment 6 participants
Start Date 2024-12-08
Primary Completion 2027-12-07 (estimated)
Study Completion 2027-12-07 (estimated)
Updated on ClinicalTrials.gov 2025-11-28