Actively Recruiting
Clinical Trial of Blinatumomab in Refractory/Active Systemic Lupus Erythematosus in Children
Led by Mao Jianhua · Updated on 2025-11-28
6
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of blinatumomab to treat children and adults with refractory or active systemic lupus erythematosus (SLE), a condition where the immune system attacks the body's own tissues. This phase 1 clinical trial aims to understand if blinatumomab can improve SLE symptoms and disease activity, while also assessing the safety and side effects experienced by participants. The study is sponsored by Mao Jianhua and focuses on patients who have not responded well to other treatments. Participants will receive two cycles of blinatumomab, each lasting five consecutive days, given as intravenous infusions. The dose is 5 micrograms per square meter per day, with a maximum of 9 micrograms per day. The second cycle starts three weeks after the first. After treatment, participants will be monitored for up to 52 weeks to assess safety and treatment effects, with regular follow-up visits and blood tests to track changes in disease activity and immune markers. During the study, participants will undergo frequent evaluations including blood tests to measure immune cell counts and disease-related antibodies. Researchers will collect data on symptom changes, serological markers, and any adverse events. The primary outcome focuses on safety within the first 12 weeks of treatment, while secondary outcomes include remission rates and immune cell changes over 24 to 52 weeks. The total participation time covers treatment and a year-long follow-up to closely monitor responses and side effects.
CONDITIONS
Brief 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) based on 2019 EULAR/ACR criteria
- Positive for at least one antibody: ANA ≥ 1:80, anti-dsDNA above normal, or anti-Smith above normal
- Inadequate response to at least three treatments including immunosuppressants or biologics
- SLEDAI-2000 score of 6 or higher
- Stable dose of oral corticosteroids, antimalarials, or immunosuppressants prior to study
- Adequate blood counts and organ function including lymphocytes, neutrophils, hemoglobin, platelets, kidney and liver function
- Left ventricular ejection fraction ≥ 55% with no significant ECG abnormalities
- Female participants of childbearing potential must have negative pregnancy test and agree to effective contraception
- Provided informed consent with legal guardian if applicable
You will not qualify if you...
- Active or unstable neuropsychiatric lupus within 60 days
- Acute severe nephritis requiring recent or ongoing renal replacement therapy or high-dose immunosuppression
- Severe antiphospholipid syndrome within 12 months
- Congenital heart disease, recent myocardial infarction, severe arrhythmia, or unstable vital signs
- Other diseases requiring long-term glucocorticoids or immunosuppressants
- Active or uncontrolled infections within 1 week before screening
- Recent organ or stem cell transplantation or active graft-versus-host disease
- History of severe recurrent or chronic infections
- Low immunoglobulin G levels
- History or evidence of hepatitis B, HIV, hepatitis C, cytomegalovirus, or Epstein-Barr virus infections
- History or active tuberculosis
- Recent macrophage activation syndrome
- Recent treatment with anti-CD19 or anti-CD20 therapies
- Recent use of JAK, BTK, or TYK2 inhibitors
- Recent treatment with cyclophosphamide or biologics
- Known allergy or intolerance to study therapy components
- Live vaccine within 4 weeks prior to screening
- Positive pregnancy test
- Known malignant diseases
- Participation in other clinical trials within 3 months
- History of depression or suicidal tendencies
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 weeks
Participants receive two 5-day cycles of Blinatumomab administered intravenously. The second cycle begins on the first day of the third week following the first cycle.
2 treatment cycles with visits on each dosing day and additional assessments during the interval between cycles
Duration - Up to 47 weeks after treatment
Participants are monitored for safety and treatment outcomes after completing Blinatumomab treatment.
Periodic visits for up to 52 weeks total from treatment start
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
X
Xiaojing Zhang, MD
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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