drugset / Trial / NCT06789107

Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus

NCT06789107

Phase 1 Recruiting 6 enrolled Mao Jianhua
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2024-12-08
Primary completion
2027-12-07
Completion
2027-12-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Blinatumomab Monoclonal antibody 5 ug/m2 Intravenous