Immune Profiling of Refractory cSLE Exposed to CD3×CD19 BiTE
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5+
SponsorThe Children's Hospital of Zhejiang University School of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 5 years.
Diagnosis of systemic lupus erythematosus (SLE) confirmed according to the 2019 EULAR/ACR classification criteria.
Inadequate response to prior standard treatments, including oral glucocorticoids, antimalarial agents, conventional immunosuppressants (cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide), and biologic therapies (telitacicept, belimumab, rituximab).
Moderate to high disease activity, such as a SLEDAI score ≥ 6. 4.Receiving CD3×CD19 bispecific T-cell engager (BiTE) therapy as part of routine clinical management, with traceable dosing information and treatment timeline.
Disqualifiers
Inability to obtain peripheral blood samples of adequate quality for immunologic analyses, including insufficient sample volume, severe hemolysis, or failure to meet predefined cell viability criteria.
Presence of acute severe infection, acute organ decompensation, or other acute medical conditions that may substantially interfere with immune profiling analyses.
Significant risk associated with blood sampling, such as severe anemia, serious coagulation disorders, or other conditions deemed by the investigator to pose unacceptable risk for phlebotomy.
Inability to obtain essential clinical data required for immune-clinical correlation analyses (e.g., disease activity scores, complement levels, autoantibody results, or renal parameters).
Trial population
The study population consists of patients with childhood-onset systemic lupus erythematosus (cSLE) who have refractory or persistently active disease and are receiving CD3×CD19 BiTE therapy under a separate, approved exploratory clinical study. Participants are enrolled in this prospective observational cohort for longitudinal immune profiling using peripheral blood samples, without assignment or modification of therapeutic interventions.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
6 Participants
are grouped into 1 trial groupGroup A: CD3×CD19BiTE-Treated cSLE Cohort
Trial outcomes
Primary outcomes
1
Change in proportions and phenotypic characteristics of peripheral blood immune cell subsets
Quantitatively characterize longitudinal changes in the proportions, phenotypes, and activation status of major peripheral immune cell populations (including B cells, T cells, and other relevant subsets) assessed by immunologic assays (primarily multiparameter flow cytometry; single-cell profiling may be used when available) in pediatric patients with refractory SLE treated with CD3×CD19 BiTE.
Time frame
From baseline through 52 weeksSecondary outcomes
1
Association between changes in peripheral blood immune cell subsets and disease activity indices
Assessment of associations between longitudinal changes in peripheral blood immune cell subsets (cell subset proportions and/or phenotypic/activation markers) and disease activity indices during follow-up after CD3×CD19 BiTE exposure.
Time frame
From baseline through 52 weeks2
Single-cell sequencing-derived gene expression and pathway activity profiles in peripheral blood immune cells
In selected samples, assessment of single-cell sequencing-derived molecular profiles, including differentially expressed genes, pathway activity, and inferred cell-cell communication signals in peripheral blood immune cells.
Time frame
From baseline through 12 weeksSponsors and contacts
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Source ClinicalTrials.gov