Study of Therapeutic Efficacy of Anti-CD19 CAR-T Cells in Refractory Systemic Lupus Erythematosus (NCT06222853) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of Therapeutic Efficacy of Anti-CD19 CAR-T Cells in Refractory Systemic Lupus Erythematosus
China22 participantsStarted 2024-02-10
Plain-language summary
This is an investigator-initiated trial aimed at assessing the safety of anti-CD19 CAR-T cells in the treatment of refractory systemic lupus erythematosus.
Who can participate
Age range5 Years
SexALL
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Inclusion criteria
✓. Age: ≥5 years old.
✓. Refractory SLE Diagnosis:
✓. Diagnosed with SLE according to the 2019 EULAR/ACR classification criteria.
✓. Exhibit persistent moderate to severe disease activity (defined as a SLEDAI-2K score ≥ 8).
✓. Demonstrated failure or to achieve target disease control (LLDAS or remission) after a minimum of 6 months of standard-of-care therapy, including: high doses of glucocorticoids (≥1mg/kg/day prednisone or equivalent), hydroxychloroquine, and at least two DMARDs (including cyclophosphamide, MMF, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide, tocilizumab, belimumab, and rituximab) for at least 6 months; or intolerant to conventional treatments.
✓. Disease Severity Validation: To ensure a "refractory" status, patients must satisfy at least one of the following:
✓. Active Major Organ Involvement (e.g., biopsy-proven Lupus Nephritis Class III, IV, or V; CNS lupus; or refractory hematological cytopenias).
✓. Steroid Dependence: Inability to taper glucocorticoid dose below 0.5 mg/kg/day (or equivalent) without a disease flare.
Exclusion criteria
✕. Prior Cell Therapy: Previous treatment with any CAR-T cell therapy or other genetically modified effector cell products.
✕. Neurological/CNS Involvement:
✕. Active central nervous system (CNS) lupus requiring clinical intervention within 60 days of screening (including seizures, delirium, or cerebrovascular events).
What they're measuring
1
The safety of CAR-T cells in refractory Systemic Lupus Erythematosus
Timeframe: 3 Months
Trial details
NCT IDNCT06222853
SponsorThe Children's Hospital of Zhejiang University School of Medicine
✕. Evidence of significant structural CNS damage on MRI or a history of severe seizures that may lower the threshold for ICANS.
✕. Severe Renal Impairment and Fibrosis:
✕. Receiving renal replacement therapy (dialysis) within 3 months prior to infusion.
✕. Irreversible Renal Damage: Documented high chronicity on baseline biopsy (e.g., Chronicity Index \>6/12) or extensive renal fibrosis, as these patients are unlikely to achieve functional recovery despite immunological remission.
✕. Significant nephropathy likely requiring high-dose glucocorticoids (≥1mg/kg/day prednisone or equivalent) or intensified DMARDs within 3 months of infusion.