Immune profiling of children with cSLE receiving CD3×CD19 BiTE therapy

A Prospective Observational Study of Immune Profiling in Childhood-Onset Systemic Lupus Erythematosus Under CD3×CD19 Bispecific T-Cell Engager Exposure

We will try to map immune changes in children with childhood-onset systemic lupus erythematosus who are receiving CD3×CD19 bispecific T‑cell engager (BiTE) therapy.

Quick facts

• Study type: Observational
• Enrollment: 6 (estimated)
• Ages: 5 Years and up
• Sex: All
• Sponsor: The Children's Hospital of Zhejiang University School of Medicine (Academic / other)
• Drugs / interventions: belimumab, rituximab, methotrexate, cyclophosphamide, immunotherapy
• Locations: 1 site (Hangzhou)
• Trial ID: NCT07352332 on ClinicalTrials.gov

What this trial studies

This is a prospective, observational, single-center cohort conducted at Children's Hospital, Zhejiang University School of Medicine that follows pediatric patients receiving CD3×CD19 BiTE therapy as part of an independent treatment protocol. Peripheral blood is collected longitudinally at predefined time points during routine clinical follow-up and analyzed by multiparameter flow cytometry, with single-cell sequencing performed on a subset of samples to explore cellular and molecular features. Clinical data including disease activity indices and serologic biomarkers are recorded in parallel to correlate immune changes with clinical course. The study does not alter or assign treatments and focuses on describing immune dynamics and potential biomarker candidates associated with changes in disease activity.

Who should consider this trial

Good fit: Children aged 5 years or older with a confirmed diagnosis of childhood-onset systemic lupus erythematosus who have refractory or persistently active disease and are receiving CD3×CD19 BiTE therapy with traceable dosing information are ideal candidates.

Not a fit: Patients who are not receiving CD3×CD19 BiTE therapy, are younger than 5 years, or lack pre- and post-treatment blood samples are unlikely to derive direct benefit from this profiling effort.

Why it matters

Potential benefit: If successful, the findings could identify immune signatures that help predict response or guide future therapies for refractory childhood-onset SLE.

How similar studies have performed: CD3×CD19 BiTEs have shown strong immunologic effects and clinical benefit in B‑cell malignancies and limited case observations in cSLE reported clinical improvement, but systematic longitudinal immune profiling in cSLE exposed to BiTE therapy remains novel.

Eligibility criteria

Inclusion Criteria:

* Participants must meet all of the following criteria:

  1. Age ≥ 5 years.
  2. Diagnosis of systemic lupus erythematosus (SLE) confirmed according to the 2019 EULAR/ACR classification criteria.
  3. Refractory or persistently active SLE, defined by clinical evaluation and meeting at least one of the following conditions:

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  1. 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).
  2. 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.

  5.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.

  6.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.

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded:

1. 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.
2. Presence of acute severe infection, acute organ decompensation, or other acute medical conditions that may substantially interfere with immune profiling analyses.
3. 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.
4. Inability to obtain essential clinical data required for immune-clinical correlation analyses (e.g., disease activity scores, complement levels, autoantibody results, or renal parameters).
5. 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.
6. Any other condition that, in the opinion of the investigator, may compromise study completion, data integrity, or participant safety.

Where this trial is running

Hangzhou

• Children's Hospital, Zhejiang University School of Medicine — Hangzhou, China (Recruiting)

Study contacts

• Study coordinator: Xiaojing Zhang, Dr

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