[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100531549":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":48,"collaborators":20,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":20,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":20,"enrollmentInfo":60,"targetDuration":20,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":23,"whyStopped":20,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Peking University People's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Experimental: JD123 injection.","EXPERIMENTAL","The relapsed\u002Frefractory AML patients will receive JD123 injections up to 3 dose levels (5.0×108 cells\u002Fdose，1.5×109 cells\u002Fdose，3.0×109 cells\u002Fdose) after FC chemotherapy.",[13],"Drug: JD123 injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","JD123 injection","JD123 injection is an universal Off-the-shelf CD123-targeted chimeric antigen receptor modified natural killer cells (CAR-NK) therapy derived from a healthy donor.",[9],null,[22],{"facility":5,"status":23,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"RECRUITING","Beijing","Beijing Municipality","100044","China","CN",{"type":30,"coordinates":31},"Point",[32,33],116.39723,39.9075,{"lat":33,"lon":32},[36,41,44,47],{"name":37,"role":38,"phone":39,"phoneExt":20,"email":40},"Meng Lv, MD PhD","CONTACT","+861088324637","drlvmeng@bjmu.edu.cn",{"name":42,"role":43,"phone":20,"phoneExt":20,"email":20},"Xiao-jun Huang, MD","PRINCIPAL_INVESTIGATOR",{"name":45,"role":46,"phone":20,"phoneExt":20,"email":20},"Xiang-yu Zhao, MD PhD","SUB_INVESTIGATOR",{"name":37,"role":46,"phone":20,"phoneExt":20,"email":20},{"type":43,"investigatorFullName":49,"investigatorTitle":50,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Xiao-Jun Huang","Professor","100531549","early-phase-1-off-the-shelf-cd123-car-nk-for-rr-aml-100531549",false,"NCT06201247","Off-the-shelf CD123 CAR-NK for R\u002FR AML","Safety and Efficacy of Universal Off-the-shelf CAR-NK Cells Targeted CD123 (JD123 Injection) in the Treatment of Refractory or Relapsed CD123-positive Acute Myeloid Leukemia","Inclusion criteria:\n\n1. Age ≥ 18 years old, no gender or race;\n2. Expected survival period ≥ 3 months;\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;\n4. The diagnosis of AML with bone marrow biopsy, immunohistochemistry or Flow cytometry definitively positive for CD123 and met the following criteria:\n\n   A. Diagnostic criteria for relapsed AML: after complete remission (CR), leukemia cells reappeared in peripheral blood or blast cells in bone marrow ≥ 5% (except for other reasons such as bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemia cell infiltration; B. Diagnostic criteria for refractory AML: naive patients who were ineffective after 2 courses of standard regimens; patients relapsed within 12 months who underwent consolidation and intensive therapy after CR; patients relapsed after 12 months but were ineffective after conventional chemotherapy; Patients with two or more relapses; patients with persistent extramedullary leukemia; Patients relapsed after allogeneic hematopoietic stem cell transplantation (allo-HSCT) C. Minimal Residual Disease (MRD) positive only or relapse: Patient is minimal residual disease (MRD) positive, as assessed on bone marrow aspirate (BMA) by Multiparameter Flow Cytometry (MFC) at time of Treatment Eligibility assessment.\n5. Adequate organ function:\n\nA. Liver function: ALT≤3×ULN, AST≤3×ULN, total bilirubin≤2×ULN; B. Coagulation function: international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5×ULN; C. Renal function: serum creatinine≤1.5×ULN or creatinine clearance rate ≥30mL\u002Fmin; D. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; 6. Women of child-bearing potential and all male participants must use effective methods of contraception for at least 12 months after infusion.; 7. Informed Consent\u002FAssent: All subjects must have the ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n1. Active Central nervous system leukemia;\n2. Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine\u002Fcyclophosphamide;\n3. Systemic use of hormones within 4 weeks prior to enrollment (except for patients with inhaled corticosteroids);\n4. Any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: HBV, HCV, HIV, syphilis infection, or active pulmonary tuberculosis.\n5. History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines;\n6. Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment;\n7. Women who are pregnant (urine\u002Fblood pregnancy test positive) or lactating;\n8. Suffering from a serious autoimmune disease or immunodeficiency disease; 9 Suffering from mental illness;\n\n10\\. Known alcohol dependence or drug dependence; 11. According to the investigator's judgment, the patient has other unsuitable grouping conditions.\n\n\\-","ALL","18 Years",{"count":61,"type":62},12,"ESTIMATED","INTERVENTIONAL",[65],"EARLY_PHASE1","This is a single-centre, single-arm, open-label, first-in-human (FIH) study to evaluate the safety, tolerability and preliminary efficacy of universal Off-the-shelf CAR-NK cells targeted CD123 (JD123 injection) in the treatment of refractory or relapsed CD123-positive acute myeloid leukemia (AML).",[68,69],"Acute Myeloid Leukemia, in Relapse","Acute Myeloid Leukemia Refractory",[71,72],"Acute Myeloid Leukemia","CAR-NK","2025-03-08",{"date":75,"type":76},"2025-03-11","ACTUAL",{"date":78,"type":76},"2023-12-30",{"date":80,"type":62},"2025-12-30",{"name":5,"class":6},1]