Childhood-onset Systemic Lupus ErythematosusBiTE-cSLE-IPNCT07352332
Immune Profiling of Refractory cSLE Exposed to CD3×CD19 BiTE
An observational study of Childhood-onset Systemic Lupus Erythematosus, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Childhood-onset Systemic Lupus Erythematosus
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2025to 30 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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:
- <!-- -->
- 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).
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital, Zhejiang University School of Medicine
Hangzhou
Xiaojing Zhang, 15867172808, 6510007@zju.edu.cn
About this study
Official title: A Prospective Observational Study of Immune Profiling in Childhood-Onset Systemic Lupus Erythematosus Under CD3×CD19 Bispecific T-Cell Engager Exposure
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.
Read the detailed description
Childhood-onset systemic lupus erythematosus (cSLE) is a severe autoimmune disease characterized by early disease onset, frequent multi-organ involvement, high disease activity, and a relapsing-remitting clinical course. Despite treatment with conventional immunosuppressive agents and biologic therapies, a subset of pediatric patients continues to experience refractory or persistently active disease.
CD3×CD19 bispecific T-cell engagers (BiTEs) redirect endogenous T cells to eliminate CD19-positive B cells and have demonstrated potent immunologic effects in B-cell malignancies. In cSLE, CD3×CD19 BiTE therapy has been administered in a limited number of patients under a separate, approved exploratory clinical study, where preliminary clinical observations suggested immune changes accompanied by improvement in disease activity. However, the immunologic effects and immune dynamics associated with CD3×CD19 BiTE exposure in cSLE have not been systematically characterized, and longitudinal immune profiling data in this context remain scarce.
The present study is designed as a prospective, observational, single-center cohort study. It does not assign, modify, or influence any therapeutic interventions. All participants receive CD3×CD19 BiTE therapy solely as part of an independent exploratory clinical protocol, and the current study focuses exclusively on immune profiling under this predefined treatment background.
Peripheral blood samples are collected longitudinally at predefined time points before and after CD3×CD19 BiTE exposure, in parallel with routine clinical follow-up. Immune profiling is primarily performed using multiparameter flow cytometry to quantify the proportions, phenotypes, and activation states of major immune cell populations, including B-cell and T-cell subsets. In a subset of samples, single-cell sequencing is conducted to further explore cellular heterogeneity, transcriptional features, and potential immune pathways associated with observed immune changes.
Clinical data are collected concurrently, including disease activity indices (such as SLEDAI), serological markers (e.g., complement levels and anti-double-stranded DNA antibodies), and organ-related clinical parameters reflecting multi-organ involvement. These clinical variables are integrated with immune profiling data to explore associations between immune features and changes in disease activity.
The primary aim of this study is to describe the peripheral immune landscape and immune cell dynamics in patients with cSLE exposed to CD3×CD19 BiTE therapy. Secondary objectives include exploring immune features associated with changes in disease activity and identifying candidate immunologic biomarkers that may inform future immune-monitoring strategies or mechanistic studies. This study does not evaluate the efficacy or safety of CD3×CD19 BiTE therapy.
By systematically integrating longitudinal immune profiling with clinical data, this observational study seeks to provide foundational immunologic insights into cSLE under CD3×CD19 BiTE exposure and to support future hypothesis-driven research in immune monitoring and personalized immunotherapy.
- Keywords
- Childhood-onset Systemic Lupus Erythematosus, Refractory Systemic Lupus Erythematosus, Immune Profiling, Bispecific T-Cell Engager, Single-Cell Sequencing, Flow Cytometry
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline through 52 weeks
Secondary outcomes (2)
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.
Measured: From baseline through 52 weeks
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.
Measured: From baseline through 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start30 Sep 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood-onset Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Children's Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Xiaojing, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352332
- Sponsor's protocol ID
- ZhangXJ1984
- Acronym
- BiTE-cSLE-IP
- Status last verified
- Jan 2026
- First submitted
- 28 Dec 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Immune Profiling in Childhood-Onset Systemic Lupus Erythematosus Under CD3×CD19 Bispecific T-Cell Engager Exposure
- ClinicalTrials.gov ID
- NCT07352332
- Acronym / sponsor ID
- BiTE-cSLE-IP / ZhangXJ1984
- Keywords
- Childhood-onset Systemic Lupus Erythematosus, Refractory Systemic Lupus Erythematosus, Immune Profiling, Bispecific T-Cell Engager, Single-Cell Sequencing, Flow Cytometry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Childhood-onset systemic lupus erythematosus (cSLE) is a severe autoimmune disease characterized by early disease onset, frequent multi-organ involvement, high disease activity, and a relapsing-remitting clinical course. Despite treatment with conventional immunosuppressive agents and biologic therapies, a subset of pediatric patients continues to experience refractory or persistently active disease.
CD3×CD19 bispecific T-cell engagers (BiTEs) redirect endogenous T cells to eliminate CD19-positive B cells and have demonstrated potent immunologic effects in B-cell malignancies. In cSLE, CD3×CD19 BiTE therapy has been administered in a limited number of patients under a separate, approved exploratory clinical study, where preliminary clinical observations suggested immune changes accompanied by improvement in disease activity. However, the immunologic effects and immune dynamics associated with CD3×CD19 BiTE exposure in cSLE have not been systematically characterized, and longitudinal immune profiling data in this context remain scarce.
The present study is designed as a prospective, observational, single-center cohort study. It does not assign, modify, or influence any therapeutic interventions. All participants receive CD3×CD19 BiTE therapy solely as part of an independent exploratory clinical protocol, and the current study focuses exclusively on immune profiling under this predefined treatment background.
Peripheral blood samples are collected longitudinally at predefined time points before and after CD3×CD19 BiTE exposure, in parallel with routine clinical follow-up. Immune profiling is primarily performed using multiparameter flow cytometry to quantify the proportions, phenotypes, and activation states of major immune cell populations, including B-cell and T-cell subsets. In a subset of samples, single-cell sequencing is conducted to further explore cellular heterogeneity, transcriptional features, and potential immune pathways associated with observed immune changes.
Clinical data are collected concurrently, including disease activity indices (such as SLEDAI), serological markers (e.g., complement levels and anti-double-stranded DNA antibodies), and organ-related clinical parameters reflecting multi-organ involvement. These clinical variables are integrated with immune profiling data to explore associations between immune features and changes in disease activity.
The primary aim of this study is to describe the peripheral immune landscape and immune cell dynamics in patients with cSLE exposed to CD3×CD19 BiTE therapy. Secondary objectives include exploring immune features associated with changes in disease activity and identifying candidate immunologic biomarkers that may inform future immune-monitoring strategies or mechanistic studies. This study does not evaluate the efficacy or safety of CD3×CD19 BiTE therapy.
By systematically integrating longitudinal immune profiling with clinical data, this observational study seeks to provide foundational immunologic insights into cSLE under CD3×CD19 BiTE exposure and to support future hypothesis-driven research in immune monitoring and personalized immunotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- Participants must meet all of the following criteria:
- <!-- -->
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in proportions and phenotypic characteristics of peripheral blood immune cell subsets
Time frame: From baseline through 52 weeks
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.
2 secondary outcomes
Association between changes in peripheral blood immune cell subsets and disease activity indices
Time frame: From baseline through 52 weeks
Single-cell sequencing-derived gene expression and pathway activity profiles in peripheral blood immune cells
Time frame: From baseline through 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood-onset Systemic Lupus Erythematosus, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaojing Zhang, Dr (81732489, 6510007@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in proportions and phenotypic characteristics of peripheral blood immune cell subsets (time frame: From baseline through 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.