Immune Profiling of Refractory cSLE Exposed to CD3×CD19 BiTE

NCT07352332 | Recruiting

• 1 other identifier: ZhangXJ1984
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Childhood-onset Systemic Lupus Erythematosus

Keywords

Childhood-onset Systemic Lupus Erythematosus; Refractory Systemic Lupus Erythematosus; Immune Profiling; Bispecific T-Cell Engager; Single-Cell Sequencing; Flow Cytometry

Outcome Measures

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.

  From baseline through 52 weeks

Secondary Outcomes (2)

• Association between changes in peripheral blood immune cell subsets and disease activity indices

  From baseline through 52 weeks

• Single-cell sequencing-derived gene expression and pathway activity profiles in peripheral blood immune cells

  From baseline through 12 weeks

Study Arms (1)

CD3×CD19BiTE-Treated cSLE Cohort

This cohort includes pediatric patients with refractory SLE who are receiving CD3×CD19 BiTE therapy as part of routine clinical care. The study does not assign treatment; BiTE administration follows standard clinical decision-making. Participants will undergo longitudinal peripheral blood collection for immune profiling using flow cytometry and single-cell sequencing methods. Clinical data will be collected in parallel to explore associations between immune features and disease activity.

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Participants must meet all of the following criteria:
• Age ≥ 5 years.
• Diagnosis of systemic lupus erythematosus (SLE) confirmed according to the 2019 EULAR/ACR classification criteria.
• Refractory or persistently active SLE, defined by clinical evaluation and meeting at least one of the following conditions:
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• 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.
• Availability of peripheral blood samples collected before and/or after CD3×CD19 BiTE exposure, obtained during routine clinical assessment or prospective follow-up, that are suitable for immunologic analyses.
• Prior informed consent obtained in a related clinical study or clinical care context that explicitly permits the storage and secondary use of biological samples and associated clinical data for disease-related scientific research, including prospective analyses during subsequent follow-up; and willingness of the child to cooperate with study follow-up procedures, as appropriate.

You may not qualify if:

• Participants meeting any of the following criteria will be excluded:
• 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).
• Refusal of the legal guardian to allow participation or withdrawal of permission for use of biological samples, or lack of assent from the child when applicable.
• Any other condition that, in the opinion of the investigator, may compromise study completion, data integrity, or participant safety.

Sponsors & Collaborators

• The Children's Hospital of Zhejiang University School of Medicine: lead

Study Sites (1)

Children's Hospital, Zhejiang University School of Medicine

Hangzhou, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Xiaojing Zhang, Dr

CONTACT

81732489; 6510007@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 20, 2026
• Study Start: September 30, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)