Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus
Trial Parameters
Brief 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.
Eligibility Criteria
Inclusion Criteria: Participants must meet all the following criteria to be eligible for enrollment: 1. Age: ≥ 5 years old. 2. Diagnosis: Diagnosed with systemic lupus erythematosus (SLE) based on the 2019 EULAR/ACR classification criteria. 3. 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). * Anti-Smith (Anti-Sm) antibody above the ULN. 4. Treatment Resistance: Inadequate response to at least three of the following: * Oral corticosteroids (OCS), * Antimalarials, * Conventional immunosuppressants (e.g., cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide), * Biologics (e.g., TULIP-2, belimumab, rituximab). At least one treatment must involve immunosuppressants or biologics. 5. SLEDAI-2000 Score: ≥ 6 based on the S