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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Xiaojing Zhang, Dr
• Email: 6510007@zju.edu.cn
• Phone: 81732489

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• CD19 CAR-T Therapy for Kids with Refractory Childhood SLE

  This study tests whether a patient’s own CD19 CAR-T cells can help children and young adults with severe, hard-to-treat lupus.

  Recruiting Phase 1 Seoul National University Hospital · Seoul · NCT07855302

• Initial glucocorticoid-dose harmonization in childhood lupus nephritis

  This trial tests whether starting children with Lupus Nephritis on a lower or higher prednisone dose makes a difference in treatment outcomes.

  Recruiting at 2 sites Phase 4 Peking Union Medical College Hospital · Beijing, Beijing Municipality and 7 other locations · NCT07719140

• Ph+ ALL in Chinese Children: Diagnosis, Treatment, and Survival

  This study tests how children in China with Philadelphia chromosome–positive ALL are diagnosed, treated, and how long they survive in real-world practice.

  Recruiting The Children's Hospital of Zhejiang University School of Medicine · Hangzhou, Zhejiang · NCT07813208

• CD19/BCMA UCART for B cell–related autoimmune diseases

  This early-stage study tests QT-219CX, a universal allogeneic CAR-T cell therapy that targets CD19 and BCMA, in people with refractory B-cell–related autoimmune diseases to see if it can be given safely and provide early signs of benefit.

  Recruiting Early Phase 1 The Children's Hospital of Zhejiang University School of Medicine · Hangzhou, Zhejiang · NCT07586267

• Allogeneic CD19/BCMA CAR‑T for B‑cell autoimmune disease

  This Phase 1 study will test a donor-derived CAR‑T therapy that targets CD19 and BCMA to try to reset the immune system in people with refractory B‑cell autoimmune diseases such as SLE, IgA nephropathy, systemic sclerosis, and resistant nephrotic syndrome.

  Recruiting Early Phase 1 The Children's Hospital of Zhejiang University School of Medicine · Hangzhou, Zhejiang · NCT07507201

• Anti-CD19/BCMA CAR‑NK cell therapy for refractory pediatric rheumatic diseases

  This trial will test a single injection of engineered CAR‑NK cells aimed at CD19 and BCMA to see if it is safe and helps children aged 5 and older whose rheumatic diseases have not responded to other treatments.

  Recruiting Early Phase 1 The Children's Hospital of Zhejiang University School of Medicine · Hangzhou, Zhejiang · NCT07490041

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.