protocolSection identificationModule nctId: NCT06308978, orgStudyIdInfo id: FT819-102, briefTitle: FT819 in Moderate to Severe Active Systemic Lupus Erythematosus, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-24, primaryCompletionDateStruct date: 2027-09-30, completionDateStruct date: 2042-09-30, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: Fate Therapeutics, class: INDUSTRY, descriptionModule briefSummary: This is a phase 1 study designed to evaluate the safety, pharmacokinetics (PK), and anti-B-cell activity of FT819 following conditioning chemotherapy in participants with moderate to severe active systemic lupus erythematosus (SLE). The study will consist of a dose-escalation stage, followed by an expansion stage to further evaluate the safety and activity of FT819., conditionsModule conditions: Systemic Lupus Erythematosus, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 32, type: ESTIMATED, armsInterventionsModule interventions name: FT819, interventions name: Fludarabine, interventions name: Cyclophosphamide, interventions name: Bendamustine, outcomesModule primaryOutcomes measure: Number of participants with treatment-emergent adverse events (TEAEs), primaryOutcomes measure: Number of participants with serious TEAEs, primaryOutcomes measure: Number of participants with adverse events of special interest (AESI), primaryOutcomes measure: Number of participants with TEAEs by severity, primaryOutcomes measure: Number of participants with dose-limiting toxicities (DLTs), primaryOutcomes measure: Recommend Phase 2 dose (RP2D) of FT819, secondaryOutcomes measure: Percentage of participants achieving definition of remission in SLE (DORIS) complete remission over time, secondaryOutcomes measure: Percentage of participants achieving DORIS clinical remission over time, secondaryOutcomes measure: Percentage of participants achieving lupus low disease activity state (LLDS) over time, secondaryOutcomes measure: Change in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) over time, secondaryOutcomes measure: Change in Physician Global Assessment (PGA) over time, secondaryOutcomes measure: Change in Functional Assessment of Chronic Illness Therapy (FACIT) over time, secondaryOutcomes measure: Change in estimated glomerular filtration rate (eGFR) over time, secondaryOutcomes measure: Change in urine creatinine over time, secondaryOutcomes measure: Change in urine protein over time, secondaryOutcomes measure: Change in protein to creatinine ratio over time, secondaryOutcomes measure: Concomitant lupus therapies prior to and following study intervention, secondaryOutcomes measure: Plasma concentration of FT819, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Minnesota Medical School, status: RECRUITING, city: Minneapolis, state: Minnesota, zip: 55455, country: United States, geoPoint lat: 44.97997, lon: -93.26384, locations facility: University of Nebraska Medical Center, status: RECRUITING, city: Omaha, state: Nebraska, zip: 68198, country: United States, geoPoint lat: 41.25626, lon: -95.94043, hasResults: False