NCT06789107
Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus
Recruiting · Phase 1 · Mao Jianhua · registry updated 2025-11-28
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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.
Inclusion
- Participants must meet all the following criteria to be eligible for enrollment:
- Age: ≥ 5 years old.
- Diagnosis: Diagnosed with systemic lupus erythematosus (SLE) based on the 2019 EULAR/ACR classification criteria.
- Positive Antibody: At least one of the following antibodies positive within 12 months before screening or during the screening period:
- Antinuclear antibody (ANA) ≥ 1:80.
- Anti-double-stranded DNA (anti-dsDNA) antibody above the upper limit of normal (ULN).
Exclusion
- Participants meeting any of the following criteria will be excluded:
- Central nervous system disease: active or unstable lupus-related neuropsychiatric disease within 60 days, including epilepsy, confusion, cerebrovascular events, etc.;
- Acute severe nephritis: renal replacement therapy within 3 months before the screening period or ongoing, or significant kidney disease that, in the opinion of the investigator, may occur and lead to the need for high-dose glucocorticoid (prednisone dose ≥ 2 mg/kg/d or equivalent of other hormones), cyclophosphamide or escalated MMF treatment within the first 3 months of the study;
- Severe antiphospholipid syndrome within 12 months before or during screening；
- Congenital heart disease or a history of acute myocardial infarction within 6 months before screening, or severe arrhythmia (including polymorphic ventricular tachycardia, ventricular tachycardia, etc.); or combined with moderate to large pericardial effusion, severe myocarditis, etc.; or unstable vital signs, patients who need blood pressure-raising drugs to maintain blood pressure;
- Suffering from other diseases that require long-term administration of glucocorticoids or immunosuppressive agents;