Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus (NCT06789107) | Clinical Trial Compass
RecruitingPhase 1
Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus
China6 participantsStarted 2024-12-08
Plain-language 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.
Who can participate
Age range5 Years
SexALL
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Inclusion criteria
β. Age: β₯ 5 years old.
β. Diagnosis: Diagnosed with systemic lupus erythematosus (SLE) based on the 2019 EULAR/ACR classification criteria.
β. Positive Antibody: At least one of the following antibodies positive within 12 months before screening or during the screening period:
β. Treatment Resistance: Inadequate response to at least three of the following:
β. SLEDAI-2000 Score: β₯ 6 based on the SLEDAI-2000 scoring system.
β. Stable Standard Treatment: Currently receiving one or more of the following treatments at a stable dose:
β. Laboratory Parameters:
β. Contraception: Female participants of childbearing potential must have a negative urine pregnancy test and agree to use effective contraception during the study and for 1 year after infusion.
Exclusion criteria
β. Central nervous system disease: active or unstable lupus-related neuropsychiatric disease within 60 days, including epilepsy, confusion, cerebrovascular events, etc.;
What they're measuring
1
safety of Blinatumomab
Timeframe: with 12 weeks of Blinatumomab treatment
β. 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 β₯ 2 mg/kg/d or equivalent of other hormones), cyclophosphamide or escalated MMF treatment within the first 3 months of the study;
β. Severe antiphospholipid syndrome within 12 months before or during screeningοΌ
β. 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;
β. Suffering from other diseases that require long-term administration of glucocorticoids or immunosuppressive agents;
β. Having active infections or uncontrollable infections that require systemic treatment within one week before screening;
β. Having received solid organ transplantation or hematopoietic stem cell transplantation within three months before screening; or having grade 2 or higher acute graft-versus-host disease (GVHD) within two weeks before screening;
β. History of severe recurrent or chronic infections, especially recurrent or chronic infections associated with respiratory problems.