Actively Recruiting
Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus
Led by Mao Jianhua · Updated on 2025-11-28
6
Participants Needed
2
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Blinatumomab in Refractory Active Childhood Systemic Lupus Erythematosus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 5 years or older
- Diagnosed with systemic lupus erythematosus (SLE) using 2019 EULAR/ACR criteria
- Positive for one or more antibodies: ANA ≥ 1:80, anti-dsDNA above normal, or anti-Smith above normal within 12 months before or during screening
- Inadequate response to at least three treatments including corticosteroids, antimalarials, immunosuppressants, or biologics; at least one must be immunosuppressants or biologics
- SLEDAI-2000 disease activity score of 6 or higher
- Stable dose of one or more standard treatments (oral corticosteroids, antimalarials, immunosuppressants) for the required time before study start
- Laboratory values within defined limits including lymphocyte count, CD19+ B cells, neutrophils, hemoglobin, platelets, heart function, kidney function, liver enzymes, and oxygen saturation
- Negative pregnancy test and agreement to use effective contraception if female of childbearing potential
- Written informed consent from participant and legal guardian
You will not qualify if you...
- Active or unstable lupus-related neuropsychiatric disease within 60 days
- Severe acute nephritis requiring recent or ongoing renal replacement therapy or high-dose treatments
- Severe antiphospholipid syndrome within 12 months
- Significant heart conditions including recent myocardial infarction, severe arrhythmias, or unstable vital signs
- Other diseases needing long-term glucocorticoids or immunosuppressive agents
- Active or uncontrolled infections needing systemic treatment within one week
- Recent solid organ or stem cell transplant or significant graft-versus-host disease
- History of severe or recurrent infections, especially respiratory-related
- Low immunoglobulin G levels below age-specific limits
- History or evidence of hepatitis B, HIV, active hepatitis C, CMV, or EBV infections
- History or active tuberculosis or unclear tuberculosis test results
- Recent macrophage activation syndrome
- Recent use of anti-CD19 or anti-CD20 therapies
- Recent use of JAK inhibitors, BTK inhibitors, TYK2 inhibitors, or certain biologics
- Known allergy or intolerance to study drugs or components
- Live vaccine within 4 weeks prior to screening
- Positive pregnancy test
- Known malignant tumors before screening
- Participation in other clinical trials within 3 months
- Depression or suicidal tendencies
- Any other condition deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310051
Actively Recruiting
2
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
J
Jianhua Mao, PhD, MD
CONTACT
X
Xiaojing Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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