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CAR-T in Children With Refractory/Recurrent Lupus Nephritis
NCT06904729Phase 3
Key facts
- Status
- Recruiting
- Start
- May 2025
- Primary completion
- Apr 2029
- Countries
- 1
- Modality
- Gene Editing, Gene Silencing, CAR-T Cells
- Conditions
- lupus nephritis (LN)
01
Overview
Phase 3, open-label, single-arm trial of anti-CD19 CAR-T cells in lupus nephritis (LN). Primary endpoint: Number of participants with CAR-T cells treatment-related adverse events at 2 years. Started May 2025; status: recruiting.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
CAR-T
Children receiving either low-dose or high-dose CAR-T cells
03
Who it enrols
Children (6-18 years) with refractory/recurrent lupus nephritis (Class III/IV) and SLEDAI-2000 >= 8, who have failed at least two immunosuppressants. Must have CD19+ B cells and adequate organ function.
04
Endpoints
Primary
Number of participants with CAR-T cells treatment-related adverse events
Secondary
Overall Renal Response rate
Number of participants with SRI-4 response
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