[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"granulomatous-polyangiitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:granulomatous-polyangiitis":33},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":38,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":5},"100542995","phase-1-fourth-gen-car-t-cells-targeting-bcmacd19-for-refractory-systemic-lupus-erythematosus-sle-100542995",false,"NCT06350110","Fourth-gen CAR T Cells Targeting BCMA\u002FCD19 for Refractory Systemic Lupus Erythematosus (SLE)","T-cell Infusion Targeting BCMA and CD19 for Refractory\u002FRelapsed Systemic Lupus Erythematosus (SLE) Patients With or Without Organs Involvement","BAH242","Inclusion Criteria:\n\n* 18-90 years old;\n* Total score ≥ 10 on the EULAR\u002FACR 2019 SLE classification criteria.\n* SELENA-SLEDAI≥8.\n* Patients with CD19+ B-cell.\n* Hemoglobin≥85 g\u002FL.\n* WBC≥2.5×10\\^9\u002FL.\n* NEUT≥1×10\\^9\u002FL.\n* BPC≥50×10\\^9\u002FL.\n* AST\u002FALT below 2 times the upper limit of normal; Creatinine clearance ≥30 mL\u002Fmin; blood bilirubin ≤2.0 mg\u002Fdl; echocardiography indicates that the ejection fraction is ≥50%.\n* Adequate venous access for apheresis, and no other contraindications for leukapheresis.\n* Women of childbearing age should have a negative serum or urine pregnancy test at screening and baseline.\n* Subjects agree to take effective contraceptive measures during the trial until at least 1 year after CAR-T cells infusion.\n* Agree to attend follow-up visits as required.\n* Voluntary participation and informed consent signed by the patient or his\u002Fher legal\u002Fauthorized representative.\n\nExclusion Criteria:\n\n* Renal disease: severe lupus nephritis (serum creatinine \\> 2.5 mg\u002FdL or 221 μmol\u002FL) within 8 weeks --Prior to leukapheresis, or subjects who need hemodialysis.\n* CNS disease: including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident \\[CVA\\], encephalitis or CNS vasculitis, psychiatric patients with depression or suicidal thoughts.\n* Patients with serious lesions and a history of present illness of vital organs such as the heart, liver,kidney blood and endocrine system.\n* Patients with immunodeficiency, uncontrolled active infections and active or recurrent peptic ulcers;\n* Received immunosuppressive therapy within 1 week prior to leukapheresis.\n* Patients with HIV infection; Active infection of hepatitis B virus or hepatitis C virus.\n* Patients with syphilis infection.\n* The presence or suspicion of an active fungal, bacterial, viral or other infection that cannot be controlled during screening.\n* Received live vaccine treatment within 4 weeks prior to screening.\n* Severe allergies or hypersensitivity.\n* Contraindication to cyclophosphamide in combination with fludarabine.\n* Subjects who have undergone major surgery within 2 weeks prior to signing the informed consent form, or who are scheduled to have surgery (other than local anesthetic surgery) during the trial or within 2 weeks of the infusion.\n* Cannula or drainage tubes other than central venous catheters.\n* Pregnant or lactating women, or subjects who plan to have children within 1 year of treatment;\n* Subjects with prior CD19 or BCMA-targeted therapy.\n* Participated in any clinical study within 3 months prior to enrollment.\n* Subjects with malignant tumour, except for Non-melanoma Skin Cancer with PFS\\>5yr; Cervical Cancer in situ; Bladder Cancer; Breast Cancer.","ALL","18 Years","90 Years",{"count":21,"type":22},75,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate.",[29,30,31,32,33,34,35,36,37],"Systemic Lupus Erythematosus","Lupus Nephritis","Autoimmune Diseases","Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis","Granulomatous Polyangiitis","Microscopic Polyangiitis","Systemic Sclerosis","Idiopathic Inflammatory Myopathies","Sjogren's Syndrome",[39],"CAR-T Cell Therapy","RECRUITING","2024-10-11",{"date":43,"type":44},"2024-10-15","ACTUAL",{"date":46,"type":44},"2024-07-10",{"date":48,"type":22},"2025-12-28",{"name":50,"class":51},"Essen Biotech","OTHER"]