Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age5+
SponsorMao Jianhua
About this trial
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.
Eligibility criteria
Qualifiers
Age: ≥ 5 years old.
Diagnosis: Diagnosed with systemic lupus erythematosus (SLE) based on the 2019 EULAR/ACR classification criteria.
Antinuclear antibody (ANA) ≥ 1:80.
Anti-double-stranded DNA (anti-dsDNA) antibody above the upper limit of normal (ULN).
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Blinatumomab 9ug
Treatment groups
6 Participants
are divided into 1 treatment groupSponsors and collaborators
Mao Jianhua
Lead sponsor
The Children's Hospital of Zhejiang University School of Medicine
Sponsor institution
Source ClinicalTrials.gov