nctId: NCT06277427 id: [2023]S208 briefTitle: Refractory ANCA Associated Vasculitis and Lupus Nephritis Treated With BCMA-targeting CAR-T Cells overallStatus: RECRUITING date: 2024-02-05 date: 2026-02-01 date: 2027-01-31 date: 2024-02-26 date: 2024-02-26 name: Lingli Dong class: OTHER name: Shenzhen Pregene Biopharma Co., Ltd. briefSummary: 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. conditions: Lupus Nephritis conditions: ANCA Associated Vasculitis studyType: INTERVENTIONAL phases: NA allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 24 type: ESTIMATED name: PRG-1801 （CAR-T against BCMA） measure: AE Incidence of PRG-1801 Single Infusion measure: Types and incidence of dose-limiting toxicity(DLT) after PRG-1801 cells infusion in subjects with refractory ANCA-associated vasculitis and refractory LN. measure: Therapeutic effects-For refractory ANCA-associated vasculitis(The proportion of subjects who maintained remission after cell infusion) measure: Therapeutic effects-For refractory ANCA-associated vasculitis(Changes in VDI (Vasculitis Damage Index) scores from baseline after cell infusion) measure: Therapeutic effects-For refractory ANCA-associated vasculitis (Changes in glomerular filtration rate compared to baseline after cell infusion in subjects with renal involvement.) measure: Therapeutic effects-For refractory LN (Changes in SLEDAI-2000 score from baseline after cell infusion) measure: Therapeutic effects-For refractory LN (Changes in FACIT fatigue score from baseline after cell infusion ) measure: Therapeutic effects-For refractory LN (Changes in PGA score (0-10) from baseline after cell infusion) measure: Therapeutic effects-For refractory LN (Changes in eGFR(mL/min/1.73 m2) relative to baseline after cell infusion) measure: Therapeutic effects-For refractory LN (Changes in UPCR (g/24h）relative to baseline after cell infusion） measure: Therapeutic effects-For refractory LN (The proportion of subjects who achieved overall response rate after cell infusion.） measure: Therapeutic effects-For refractory LN（The proportion of subjects who achieved complete renal response after cell infusion.） measure: PK feature evaluation (PK parameters related to CAR copy number） measure: Serum sBCMA level measure: Serum ANCA titer level (AAV) measure: Serum dsDNA level (LN) measure: Serum ANA titer level (LN) measure: Serum complement C3 levels measure: Serum complement C4 levels measure: Serum immunoglobulin quantification measure: Levels of CRP levels measure: Levels of ferritin levels measure: Levels of cytokine levels measure: Changes of peripheral blood lymphocyte subsets measure: Expression levels of BCMA on peripheral blood B cell subsets surface measure: The level of anti drug antibody (ADA) sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Tongji Hospital status: RECRUITING city: Wuhan state: Hubei zip: 430030 country: China name: Lingli Dong, MD role: CONTACT phone: 86-27-83665519 email: tjhdongll@163.com name: Cong Ye, MD role: CONTACT phone: 86-27-83665518 email: Yecong@163.com lat: 30.58333 lon: 114.26667 hasResults: False