Actively Recruiting
Immune Profiling of Refractory cSLE Exposed to CD3×CD19 BiTE
Led by The Children's Hospital of Zhejiang University School of Medicine · Updated on 2026-01-20
6
Participants Needed
1
Research Sites
117 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This prospective observational study aims to characterize the peripheral immune landscape of pediatric patients with childhood-onset systemic lupus erythematosus ( cSLE) who are receiving CD3×CD19 bispecific T-cell engager (BiTE) therapy under a separate, approved exploratory clinical study. The present study does not assign, modify, or influence any therapeutic interventions. Peripheral blood samples are collected longitudinally at predefined time points in parallel with routine clinical follow-up. Immune profiling is performed using multiparameter flow cytometry, with single-cell sequencing conducted in a subset of samples to further explore cellular and molecular features. Clinical data, including disease activity indices and relevant serological biomarkers, are recorded concurrently. The objective of this study is to describe immune cell dynamics and immune features associated with changes in disease activity in cSLE, and to explore potential biomarker candidates that may inform future immune-monitoring strategies and mechanistic research in this population.
CONDITIONS
Official Title
Immune Profiling of Refractory cSLE Exposed to CD3×CD19 BiTE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 5 years or older
- Confirmed diagnosis of systemic lupus erythematosus (SLE) according to 2019 EULAR/ACR criteria
- Refractory or persistently active SLE, shown by inadequate response to prior treatments or moderate to high disease activity (SLEDAI score 6)
- Currently receiving CD3�d7CD19 bispecific T-cell engager (BiTE) therapy with traceable dosing and timeline
- Availability of peripheral blood samples collected before and/or after BiTE therapy suitable for immunologic analysis
- Prior informed consent obtained allowing storage and use of biological samples and clinical data for research, with willingness to cooperate with study follow-up
You will not qualify if you...
- Inability to obtain adequate peripheral blood samples for immune analysis
- Presence of acute severe infection, organ failure, or other acute medical conditions interfering with immune profiling
- Significant risk for blood sampling such as severe anemia or coagulation disorders
- Lack of essential clinical data needed for immune and disease activity correlation
- Refusal or withdrawal of permission for participation or use of biological samples by legal guardian or child
- Any other condition that may affect study completion, data quality, or participant safety as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, China
Actively Recruiting
Research Team
X
Xiaojing Zhang, Dr
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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