2026-01-30
minor
Study Status, Oversight, Study Description, Arms and Interventions, Outcome Measures, Eligibility, References v3
Eligibility criteria+1,184 characters
Inclusion Criteria:
Age: ≥5 years old;.
Refractory SLE Diagnosis:
Diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria；Still.
Exhibit inpersistent moderate to severe disease activity despite(defined as a SLEDAI-2K score ≥3M 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 dosedoses of glucocorticoids (prednisone≥1mg/kg/dday prednisone or other equivalent amount of other steriod ), hydroxychloroquine, and at least 2two ofDMARDs the(including following treatments(c [...] [...]
Secondary endpoints3 to 6 entries
CellularThe kineticsefficacy of CAR-T cells in refractory Systemic Lupus Erythematosus
SerologicalLLDAS response rate.
DORIS response rate.
Evaluate the Pharmacokinetics parameters.
Evaluate the Pharmacodynamics parameters.
Changes in serological biomarkers detection
Durationrelated ofwith disease response (DOR)SLE
Primary endpoints2 to 1 entries
The efficacysafety of CAR-T cells in refractory Systemic Lupus Erythematosus
The safety of CAR-T cell in refractory Systemic Lupus Erythematosus
Publicationsdetails revised at 7 of 7 entries
2025-08-26
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Outcome Measures, Contacts/Locations v2
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2026-12-30→confirmed 2025-04-04
Start date2024-01-04→2024-02-10
Enrollment targetestimated 18→confirmed 22
Secondary endpoints4 to 3 entries
TheSerological efficiency of CAR-T cell in refractory Systemic lupus Erythematosus.
Autoantibodybiomarkers detection
Primary endpoints1 to 2 entries
The efficacy of CAR-T cells in refractory Systemic Lupus Erythematosus
Study sitesdetails revised at 1 of 1 site
2024-09-06
minor
Study Identification, Study Status, Oversight, Study Description, Conditions, Study Design, Arms and Interventions, Outcome Measures, Eligibility, References v1
Eligibility criteria-23 characters
Inclusion Criteria:
Age:≥5-18 years old(including threshold);
Diagnosed with SLE according to the 2019 EULAR/ACR SLE cla [...]
Secondary endpoints4 entries, revised
The efficiency of CAR-T cell in refractory childhood-onset Systemic lupus Erythematosus.
Primary endpoints1 entry, revised
The safety of CAR-T cell in refractory childhood-onset Systemic Lupus Erythematosus
Study description-16 characters
[...] d efficacy of the anti-CD19 CAR-T cells in the treatment of childhood-onset refractory SLE.
Publicationsdetails revised at 7 of 7 entries
Study title-14 characters
Study of Therapeutic Efficacy of Anti-CD19 CAR-T Cells in Children With Refractory Systemic Lupus Erythematosus
2024-01-15
minor
Original filing