Clinical Research Directory
Browse clinical research sites, groups, and studies.
Immune Profiling of Refractory cSLE Exposed to CD3×CD19 BiTE
Sponsor: The Children's Hospital of Zhejiang University School of Medicine
Summary
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.
Official title: A Prospective Observational Study of Immune Profiling in Childhood-Onset Systemic Lupus Erythematosus Under CD3×CD19 Bispecific T-Cell Engager Exposure
Key Details
Gender
All
Age Range
5 Years - Any
Study Type
OBSERVATIONAL
Enrollment
6
Start Date
2025-09-30
Completion Date
2027-12-30
Last Updated
2026-01-20
Healthy Volunteers
No
Locations (1)
Children's Hospital, Zhejiang University School of Medicine
Hangzhou, China