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