[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"extra-renal-lupus-erl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:extra-renal-lupus-erl":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100630763","phase-1-a-phase-1-study-of-hb2198-in-participants-with-moderately-to-severely-active-systemic-lupus-erythematosus-sle-100630763",false,"NCT07491900","A Phase 1 Study of HB2198 in Participants With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)","A Phase 1, Open Label Dose Escalating Study of HB2198, a Tetravalent Bispecific Anti-CD19\u002FCD20 Antibody With Dual Fc Domains, in Patients With Moderately to Severely Active Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* • Meet 2019 ACR \u002F 2023 EULAR SLE classification criteria\n\n  * Moderate or high disease activity (SLEDAI 2K ≥6; PGA ≥1)\n  * LN participants: biopsy confirmed active Class III\u002FIV ± V or Class V LN; proteinuria ≥0.8 g\u002Fg; eGFR ≥30 mL\u002Fmin\u002F1.73 m²\n  * ERL participants: inadequate response\u002Fintolerance to ≥1 standard SLE therapy\n  * Positive ANA (≥1:80) or SLE associated autoantibodies\n  * Required minimum lab values (lymphocytes ≥500\u002FµL, B cells ≥25\u002FµL, ANC ≥1000\u002Fmm³, IgG ≥600 mg\u002FdL, etc.)\n  * Women of childbearing potential: negative pregnancy test; contraception required\n  * Voluntary informed consent\n\nExclusion Criteria:\n\n* (Key) Inclusion Criteria:\n\n  * Meet 2019 ACR \u002F 2023 EULAR SLE classification criteria\n  * Moderate or high disease activity (SLEDAI 2K ≥6; PGA ≥1)\n  * LN participants: biopsy confirmed active Class III\u002FIV ± V or Class V LN; proteinuria ≥0.8 g\u002Fg; eGFR ≥30 mL\u002Fmin\u002F1.73 m²\n  * ERL participants: inadequate response\u002Fintolerance to ≥1 standard SLE therapy\n  * Positive ANA (≥1:80) or SLE associated autoantibodies\n  * Required minimum lab values (lymphocytes ≥500\u002FµL, B cells ≥25\u002FµL, ANC ≥1000\u002Fmm³, IgG ≥600 mg\u002FdL, etc.)\n  * Women of childbearing potential: negative pregnancy test; contraception required\n  * Voluntary informed consent\n\n(Key) Exclusion Criteria:\n\n* Anti CD19 or anti CD20 therapy within 6 months\n* Active CNS lupus\n* Significant cardiovascular, pulmonary, hepatic, or uncontrolled systemic disease\n* Active infection or recent serious infection\n* Positive HBV DNA or HCV RNA; HIV infection\n* Major surgery within 4 weeks\n* Prior organ or stem cell transplant\n* Current pregnancy or breastfeeding\n* Recent IVIg or plasmapheresis (\\\u003C3 months)\n* Live vaccine within 30 days\n* Any condition judged unsuitable by Investigator","ALL","18 Years","65 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This Phase 1, open label, dose escalation study evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary clinical activity of HB2198, a tetravalent bispecific anti CD19\u002FCD20 antibody, in adults with moderately to severely active systemic lupus erythematosus (SLE), including lupus nephritis and extra renal lupus. Approximately 30 participants will receive two intravenous doses of HB2198 and be followed for 12 months to assess safety, B cell depletion, disease activity, immunologic biomarkers, and renal outcomes.",[27,28,29],"Systemic Lupus Erthematosus (SLE)","Lupus Nephritis (LN)","Extra-renal Lupus (ERL)","RECRUITING","2026-03-18",{"date":33,"type":34},"2026-03-25","ACTUAL",{"date":36,"type":21},"2026-03-23",{"date":38,"type":21},"2028-10-24",{"name":40,"class":41},"Hinge Bio","INDUSTRY"]