NCT07352332 Immune Profiling of Refractory cSLE Exposed to CD3×CD19 BiTE
| NCT ID | NCT07352332 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Children's Hospital of Zhejiang University School of Medicine |
| Condition | Childhood-onset Systemic Lupus Erythematosus |
| Study Type | OBSERVATIONAL |
| Enrollment | 6 participants |
| Start Date | 2025-09-30 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 6 participants in total. It began in 2025-09-30 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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: <!-- --> 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07352332 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, studying Childhood-onset Systemic Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07352332 currently recruiting?
Yes, NCT07352332 is actively recruiting participants. Contact the research team at 6510007@zju.edu.cn for enrollment information.
Where is the NCT07352332 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07352332 clinical trial?
NCT07352332 is sponsored by The Children's Hospital of Zhejiang University School of Medicine. The trial plans to enroll 6 participants.
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