NCT06789107

Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Mao Jianhua · Academic / Other
• Sex: All
• Age: 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Lupus Erythematosus (SLE)
• Children
• Blinatumomab

Interventions

Type	Name	Description
DRUG	Blinatumomab 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.

Timeline

• Start date: 2024-12-08
• Primary completion: 2027-12-07
• Completion: 2027-12-07
• First posted: 2025-01-23
• Last updated: 2025-11-28

Locations

2 sites across 1 country: China

Regulatory

• FDA-regulated drug study