[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100542995":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":29,"responsibleParty":49,"collaborators":22,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":22,"studyType":65,"phases":66,"briefSummary":69,"conditions":70,"keywords":80,"overallStatus":32,"whyStopped":22,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Essen Biotech","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Treatment (CD19\u002FBCMA-CAR T cells, chemotherapy)","EXPERIMENTAL","Treatment (CD19\u002FBCMA-CAR T cells, chemotherapy)\n\nPatients will be administered fludarabine phosphate intravenously (IV) over a 30-minute period on days -4 to -2. Additionally, cyclophosphamide will be administered intravenously (IV) over 60 minutes on day -2. Subsequently, patients will receive CD19\u002FBCMA-CAR T cells intravenously (IV) over a duration of 10-20 minutes on day 0. Patients who exhibit positive responses to the initial dose of CD19\u002FBCMA-CAR T cells, do not experience unacceptable side effects, and have a sufficient quantity of cells available may be eligible to receive 2 or 3 additional doses of CD19\u002FBCMA-CAR T cells.",[13],"Biological: CD19- BCMA CAR-T cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","CD19- BCMA CAR-T cells","The intervention in this clinical trial involves a novel approach using CD19\u002FBCMA-Chimeric Antigen Receptor T (CAR T) cells combined with chemotherapy. The goal is to assess safety and efficacy in patients with specific hematologic malignancies.\n\nTreatment Regimen:\n\nPatients in the trial will undergo the following regimen:\n\nFludarabine Phosphate (Days -4 to -2): IV administration of fludarabine phosphate over 30 minutes on days -4 to -2. It's part of the preparatory regimen to enhance the body's response to CAR T-cell therapy.\n\nCyclophosphamide (Day -2): IV cyclophosphamide over 60 minutes on day -2.\n\nCD19\u002FBCMA-Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, CD19\u002FBCMA-CAR T cells, over 10-20 minutes on day 0.\n\nAdditional Doses: Eligible patients responding well to the initial CD19\u002FBCMA-CAR T cell infusion without unacceptable side effects and sufficient CAR T cell availability may receive 2 or 3 additional doses.",[9],[21],"EB-BH2024-2",null,[24],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Rhoda M Smith, Phd","CONTACT","+12077706670","clinical-trials@essen-biotech.com",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"District One Hospital","RECRUITING","Beijing","Beijing Municipality","086-373","China","CN",{"type":39,"coordinates":40},"Point",[41,42],116.39723,39.9075,{"lat":42,"lon":41},[45],{"name":46,"role":26,"phone":47,"phoneExt":22,"email":48},"SAMI XI, dr","+14012275001","SFM@districtonehospital.com",{"type":50,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","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":63,"type":64},75,"ESTIMATED","INTERVENTIONAL",[67,68],"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.",[71,72,73,74,75,76,77,78,79],"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",[81],"CAR-T Cell Therapy","2024-10-11",{"date":84,"type":85},"2024-10-15","ACTUAL",{"date":87,"type":85},"2024-07-10",{"date":89,"type":64},"2025-12-28",{"name":5,"class":6},1]