[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633196":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":36,"locations":42,"responsibleParty":62,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Beijing Biotech","INDUSTRY",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"CD19-selected","EXPERIMENTAL","Participants with a B-cell-dominant disease profile (for example, measurable circulating CD19-positive B cells, active serology, and no strong evidence of plasma-cell-dominant refractory disease) receive autologous anti-CD19 CAR-T cells after lymphodepletion.",[13,14,15],"Biological: Autologous anti-CD19 CAR-T cells, intravenous single infusion at protocol-defined dose level (1 x 10^6 or 3 x 10^6 CAR-positive viable T cells\u002Fkg).","Drug: Fludarabine","Drug: Cyclophosphamide",{"label":17,"type":10,"description":18,"interventionNames":19},"BCMA-Selected CAR-T","Participants with a plasma-cell-dominant or BCMA-preferred profile (for example, persistent autoantibody production after prior B-cell depletion, high plasmablast\u002Fplasma-cell markers, or active nephritis with ongoing serologic activity) receive autologous anti-BCMA CAR-T cells after lymphodepletion.",[13,14,15],[21,27,32],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Autologous anti-CD19 CAR-T cells, intravenous single infusion at protocol-defined dose level (1 x 10^6 or 3 x 10^6 CAR-positive viable T cells\u002Fkg).","Autologous anti-CD19 CAR-T cells are patient-derived T lymphocytes that are genetically engineered to target CD19-expressing B cells. In clinical trials, a single intravenous infusion is administered at a protocol-defined dose (e.g., 1 × 10⁶ or 3 × 10⁶ CAR-positive viable T cells per kg) to evaluate safety, tolerability, and preliminary efficacy.",[17,9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Fludarabine","30 mg\u002Fm2\u002Fday IV on Days -5 to -3.",[17,9],{"type":28,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"Cyclophosphamide","300 mg\u002Fm2\u002Fday IV on Days -5 to -3.",[17,9],[37],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"shan S Lu, Phd","CONTACT","+86 13076790030","Seni-Lu@beijing-biotech.com",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Peking University Shenzhen Hospital","RECRUITING","Shenzhen","Guangdong","518036","China","CN",{"type":52,"coordinates":53},"Point",[54,55],114.0683,22.54554,{"lat":55,"lon":54},[58],{"name":59,"role":39,"phone":60,"phoneExt":26,"email":61},"Zhen J Peng, Phd","+86 13076790039","Zhen-Peng@beijing-biotech.com",{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100633196","phase-1-select-sle-biomarker-guided-car-t-target-selection-for-refractory-lupus-100633196",false,"NCT07523542","SELECT-SLE: Biomarker-Guided CAR-T Target Selection for Refractory Lupus","A Phase 1\u002F2, Open-Label, Biomarker-Guided, Non-Randomized, Multicenter Study of Autologous CAR-T Cell Therapy Targeting CD19 or BCMA in Adults With Refractory Systemic Lupus Erythematosus With or Without Active Lupus Nephritis.","SELECT-SLE","Inclusion Criteria:\n\n* 1\\. Age 18 to 70 years at consent. 2. Meets 2019 EULAR\u002FACR classification criteria for SLE, with total score \\>= 10.\n\n  3\\. Active refractory disease at screening, defined by SELENA-SLEDAI \\>= 8, or at least one BILAG A domain, or at least two BILAG B domains, or active lupus nephritis with significant proteinuria and active urinary sediment.\n\n  4\\. Inadequate response, intolerance, or contraindication to at least 2 prior standard systemic regimens, including at least 1 immunosuppressant or biologic used for SLE or lupus nephritis. 5. Demonstrable targetable biology and assignment to one protocol arm: CD19 arm for measurable CD19-positive B-cell \u002F B-cell-dominant disease, or BCMA arm for BCMA-positive plasmablast \u002F plasma-cell-dominant disease and\u002For persistent serologic activity after prior B-cell depletion. 6. If active lupus nephritis is present, biopsy-proven class III, IV, V, or mixed proliferative \u002F membranous LN within the previous 24 months, or investigator confirmation that repeat biopsy is unsafe but the clinical picture strongly supports active LN. 7. Adequate organ function: hemoglobin \\>= 8.5 g\u002FdL, ANC \\>= 1.0 x 10\\^9\u002FL, platelets \\>= 50 x 10\\^9\u002FL, AST \u002F ALT \\\u003C= 2.5 x ULN, creatinine clearance \\>= 30 mL\u002Fmin, bilirubin \\\u003C= 2.0 mg\u002FdL unless otherwise explained, and LVEF \\>= 50%.\n\n  8\\. Adequate venous access and eligibility for leukapheresis. 9. Negative pregnancy test and agreement to use effective contraception for 12 months after infusion.\n\n  10\\. Ability to discontinue prohibited SLE medications per washout rules and willingness to comply with inpatient observation and long-term follow-up. 11. Written informed consent.\n\nExclusion Criteria:\n\n* 1\\. Active uncontrolled infection, including active tuberculosis, hepatitis B or C with active replication, or HIV.\n\n  2\\. Prior CAR-T therapy or prior CD19- or BCMA-directed cell therapy. 3. Severe active CNS lupus requiring urgent escalation of immunosuppression, uncontrolled seizure disorder, or stroke within 60 days before screening. 4. End-stage organ failure not expected to improve with immune reset, such as dialysis-dependent kidney failure, uncontrolled advanced heart failure, or ICU-level respiratory instability. 5. Active malignancy or history of malignancy within 5 years, except adequately treated non-melanoma skin cancer, cervical carcinoma in situ, or other low-risk malignancy in durable remission. 6. Pregnant or breastfeeding. 7. Allogeneic hematopoietic stem cell transplant or solid organ transplant history.\n\n  8\\. Contraindication to fludarabine, cyclophosphamide, leukapheresis, or standard rescue medications for CRS \u002F ICANS. 9. Live vaccine within 4 weeks before lymphodepletion. 10. Participation in another interventional clinical study within 3 months before enrollment.\n\n  11\\. Uncontrolled psychiatric disease, active substance misuse, or social circumstances that would impair adherence.\n\n  12\\. Any condition that, in the investigator's judgment, makes participation unsafe or confounds interpretation of the study endpoints.","ALL","18 Years","70 Years",{"count":76,"type":77},24,"ESTIMATED","INTERVENTIONAL",[80,81],"PHASE1","PHASE2","study evaluates a biomarker-guided strategy to assign adults with refractory SLE to autologous CAR-T therapy targeting either CD19 or BCMA. Participants undergo centralized screening immunophenotyping to determine whether their disease appears B-cell-dominant (CD19-preferred) or plasma-cell-dominant (BCMA-preferred), followed by leukapheresis, lymphodepletion, and a single CAR-T infusion. The main goals are to assess safety, determine a recommended Phase 2 dose within each arm, and estimate remission rates by Week 24.",[84,85],"REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS","Lupus Nephritis",[87,88,89,90,91,92,93,94,95,96],"autologous T cells","B-cell depletion","BCMA","biomarker-guided therapy","CAR-T","CD19","immune reset","lupus nephritis","plasma-cell depletion","refractory lupus","2026-04-05",{"date":99,"type":100},"2026-04-13","ACTUAL",{"date":102,"type":100},"2026-03-02",{"date":104,"type":77},"2028-10-17",{"name":5,"class":6},1]