[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100548366":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":75,"overallStatus":32,"whyStopped":22,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Essen Biotech","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (CD33\u002FCD123 CAR T cells, chemotherapy)","EXPERIMENTAL","Patients 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 CD33\u002F123 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 CD33\u002F123 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 CD33\u002FCD123 CAR T cells.",[13],"Biological: CD123\u002FCD33 CART",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","CD123\u002FCD33 CART","The intervention in this clinical trial involves a novel approach using CD22\u002F123-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\nCD33\u002F123-Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, CD33\u002F123-CAR T cells, over 10-20 minutes on day 0.\n\nAdditional Doses: Eligible patients responding well to the initial CD33\u002F123 CAR-T cell infusion without unacceptable side effects and sufficient CAR T cell availability may receive 2 or 3 additional doses.",[9],[21],"EB-BH2025",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","100548366","phase-1-sequential-car-t-cells-targeting-cd33cd123-in-patients-with-acute-myelocytic-leukemia-aml-100548366",false,"NCT06420063","Sequential CAR-T Cells Targeting CD33\u002FCD123 in Patients With Acute Myelocytic Leukemia AML","Sequential CAR-T Cell Infusion Targeting CD33 and CD123 for Refractory\u002FRelapsed Acute Myeloid Leukaemia","BAH244","Inclusion Criteria:\n\n* Subjects with acute myeloid leukemia who voluntarily signed informed consent and met the following criteria:\n* Age older than 6 months.\n* Confirmed expression of CLL-1, CD123 and\u002For CD33 in blast AML by immuno-histochemical staining or flow cytometry.\n* Karnofsky performance status (KPS) score is higher than 80 and life expectancy \\> 3 months.\n* Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg\u002FdL.\n* Hgb≥80g\u002FL.\n* No cell separation contraindications.\n* Abilities to understand and the willingness to provide written informed consent.\n\nExclusion Criteria:\n\n* Severe illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection.\n* Active bacterial, fungal or viral infection not controlled by adequate treatment.\n* Known HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n* Pregnant or nursing women may not participate.\n* Use of glucocorticoid for systemic therapy within one week prior to entering the trial.\n* Patients, in the opinion of investigators, may not be able to comply with the study.","ALL","6 Years","90 Years",{"count":63,"type":64},85,"ESTIMATED","INTERVENTIONAL",[67,68],"PHASE1","PHASE2","This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting CD33 or CD123 or both sequentially in the treatment of Acute Myelocytic Leukemia.",[71,72,73,74],"AML","Acute Myeloid Leukemia","AML, Adult Recurrent","AML, Adult",[76,77,78,79],"aml","cd33","cd123","CAR-T","2024-11-10",{"date":82,"type":83},"2024-11-12","ACTUAL",{"date":85,"type":83},"2024-07-10",{"date":87,"type":64},"2026-12-28",{"name":5,"class":6},1]