Study of Blinatumomab Treatment for Children and Adults with Active Systemic Lupus Erythematosus Not Responding to Other Therapies

What this Trial Is About

Researchers are evaluating the use of blinatumomab to treat children and adults with refractory or active systemic lupus erythematosus SLE, a condition where the immune system attacks the bodys own tissues. This phase 1 clinical trial aims to understand if blinatumomab can improve SLE symptoms and disease activity, while also assessing the safety and side effects experienced by participants. The study is sponsored by Mao Jianhua and focuses on patients who have not responded well to other treatments. Participants will receive two cycles of blinatumomab, each lasting five consecutive days, given as intravenous infusions. The dose is 5 micrograms per square meter per day, with a maximum of 9 micrograms per day. The second cycle starts three weeks after the first. After treatment, participants will be monitored for up to 52 weeks to assess safety and treatment effects, with regular follow-up visits and blood tests to track changes in disease activity and immune markers. During the study, participants will undergo frequent evaluations including blood tests to measure immune cell counts and disease-related antibodies. Researchers will collect data on symptom changes, serological markers, and any adverse events. The primary outcome focuses on safety within the first 12 weeks of treatment, while secondary outcomes include remission rates and immune cell changes over 24 to 52 weeks. The total participation time covers treatment and a year-long follow-up to closely monitor responses and side effects.

Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus