CD19 CAR-T Therapy for Kids with Refractory Childhood SLE

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 early-phase study evaluates the safety and potential benefits of autologous CD19 CAR-T cell therapy in participants aged 25 years or younger with refractory childhood-onset systemic lupus erythematosus. Each participant’s T cells are collected, engineered to recognize CD19, and given back after a lymphodepleting chemotherapy regimen, followed by a single infusion. Participants will be monitored for adverse effects and changes in disease activity, organ involvement, lab results, and steroid-sparing needs, with a primary assessment at one year post-infusion. The trial plans to enroll up to eight participants at Seoul National University Hospital. The study aims to determine if this approach can modulate the immune system and reduce lupus activity in a pediatric-onset population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participants must be 25 years of age or younger at the time of SNUH-CD19-CAR-T infusion.
2. Participants must have a diagnosis of systemic lupus erythematosus and meet the 2019 European Alliance of Associations for Rheumatology/American College of Rheumatology classification criteria for systemic lupus erythematosus.
3. Participants must be currently receiving or have previously received at least three of the following therapies, including corticosteroids: hydroxychloroquine, methotrexate, cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, rituximab, or belimumab.
4. Participants must have involvement of at least one of the following major organ systems:

   * Kidney: class II-V lupus nephritis confirmed by biopsy or proteinuria greater than 0.5 g/day
   * Heart: pericarditis, myocarditis, conduction abnormality, or valvular disease
   * Lung: pleuritis, interstitial lung disease, or pulmonary arterial hypertension
   * Hematologic system: platelet count below 50,000/μL or hemolytic anemia
5. Participants must have uncontrolled active disease, defined as a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of 10 or higher.

Exclusion Criteria:

1. Severe active central nervous system lupus requiring current treatment, including uncontrolled seizures, psychotic symptoms, or cognitive impairment.
2. Inability to obtain an adequate leukapheresis product suitable for the manufacture of SNUH-CD19-CAR-T cells.
3. Known human immunodeficiency virus infection.
4. Uncontrolled active infection, as determined by the investigator. An infection will be considered controlled if appropriate treatment has been administered and there is no evidence of progression at enrollment. Persistent fever without other signs or symptoms of infection will not, by itself, be considered evidence of progressive infection.
5. Pregnancy or breastfeeding.
6. Any medical or other condition that, in the investigator's clinical judgment, makes participation in the study inappropriate.

Where it's running

• Seoul National University Hospital
  Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Hye Ji, CRC
• Email: hyeji91@snu.ac.kr
• Phone: 82-10-2957-8895

Similar studies

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

• CAR-T Therapy Safety, Response, and Immune-Escape: Observational Study in Adults

  This observational study looks at adults who receive CAR-T cell therapy or bispecific antibodies to see which factors predict response and immune-related side effects.

  Recruiting IRCCS San Raffaele · Milan, Italy · NCT07915102

• Natalizumab to help prevent brain-related side effects during CAR-T therapy in certain lymphoma patients

  This phase 2 study tests whether natalizumab can reduce severe ICANS in adults with recurrent or refractory DLBCL or MCL receiving CAR-T therapy.

  Recruiting Phase 2 University of Michigan Rogel Cancer Center · Ann Arbor, Michigan · NCT07892027

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

  This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• CAR-T Cell Therapy for B-ALL (relapsed/refractory)

  This trial tests a patient’s own CAR-T cells to treat relapsed or refractory B-cell ALL in people aged 5–50.

  Recruiting Early Phase 1 National Institute of Blood and Marrow Transplant (NIBMT), Pakistan · Rawalpindi · NCT07695012

• Bendamustine vs standard lymphodepletion before CAR-T in LBCL

  This trial tests whether bendamustine can replace the standard bendamustine-free lymphodepletion before CAR-T therapy in adults with large B-cell lymphoma who have had prior treatment.

  Recruiting at 8 sites Phase 2 Swiss Cancer Institute · Aarau and 8 other locations · NCT07593482

• Dual-target CD22/CD19 CAR-T consolidation after first remission in high-risk B-ALL

  This test will try a dual-target CD22/CD19 CAR-T cell treatment as consolidation for patients with high-risk B-cell acute lymphoblastic leukemia who are in their first remission.

  Recruiting Phase 1/2 Chinese PLA General Hospital · Beijing, Beijing Municipality · NCT07575971

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.