Clinical Trial

Refractory ANCA Associated Vasculitis and Lupus Nephritis Treated With BCMA-targeting CAR-T Cells

Recruiting
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Record status
This record was last updated February 26, 2024 (before its estimated February 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
Lupus nephritis (LN) and ANCA-associated vasculitis are severe autoimmune diseases, which may lead to the death of patients, particularly when they are refractory to the conventional therapeutic agents. Based on the current knowledge, the autoantibodies against self-antigens may exert important pathological roles in the pathogenesis of both LN and ANCA-associated vasculitis, of which the origins are primarily plasmablasts and plasma cells. BCMA is the molecule expressed on memory B cells, plasmablasts and plasma cells, and therefore is an ideal target for the elimination of potential pathogenic antibody secreting cells. Chimeric antigen receptor (CAR) T cells against BCMA may provide a novel therapeutic way for the refractory LN and ANCA-associated vasculitis patients to eliminate the pathogenic autoantibody-secreting cells. In this study, the safety and efficacy of a novel CAR-T cell therapy using PRG-1801 cells, are evaluated in patients with refractory LN and ANCA-associated vasculitis.
Trial Details
NCT Number NCT06277427
Lead Sponsor Lingli Dong
Collaborators: Shenzhen Pregene Biopharma Co., Ltd.
Conditions Lupus Nephritis, ANCA Associated Vasculitis
Enrollment 24 participants
Start Date 2024-02-05
Primary Completion 2026-02-01 (estimated)
Study Completion 2027-01-31 (estimated)
Updated on ClinicalTrials.gov 2024-02-26