[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565397":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":33,"responsibleParty":51,"collaborators":20,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":20,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":20,"enrollmentInfo":62,"targetDuration":20,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":35,"whyStopped":20,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NK cell treatment in AML replase after HSCT","EXPERIMENTAL","The relapsed AML patients will receive donor NK cells injections for a total dose of twice per 2 weeks up to 3 dose levels (1.0×108 cells\u002Fdose，5.0×108 cells\u002Fdose，2.0×109 cells\u002Fdose), followed by low-dose interleukin-2 (1mIU ih, Qd) for 28 days.",[13],"Drug: NK cell",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","NK cell","Drug: Donor NK cells injection is a non-genetically modified natural killer cells therapy derived from a healthy donor.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Yujun Dong, Docter","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","8683575680","dongy@hsc.pku.edu.cn",{"name":31,"role":27,"phone":20,"phoneExt":20,"email":32},"Bingjie Wang","wbj880202@163.com",[34],{"facility":5,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Beijing","Beijing Municipality","100034","China","CN",{"type":42,"coordinates":43},"Point",[44,45],116.39723,39.9075,{"lat":45,"lon":44},[48],{"name":49,"role":27,"phone":50,"phoneExt":20,"email":29},"Yujun Dong","+86 18210264969",{"type":24,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Yujun DONG","chief of department of hematology","100565397","phase-1-a-phase-i-single-arm-clinical-study-of-donor-nk-cells-infusion-combined-with-low-dose-interleukin-2-in-the-treatment-of-acute-myeloid-leukemia-relapse-after-allogeneic-hematopoietic-stem-cell-transplantation-100565397",false,"NCT06641648","A Phase I Single-arm Clinical Study of Donor NK Cells Infusion Combined With Low-dose Interleukin-2 in the Treatment of Acute Myeloid Leukemia Relapse After Allogeneic Hematopoietic Stem Cell Transplantation.","Inclusion Criteria:\n\n* Age ≥ 18 years old,;\n* Expected survival period ≥ 3 months;\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;\n* The diagnosis of AML who received allo-HSCT, and met the following criteria:\n\nA. 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. 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; C. Degree II and above acute graft-versus-host disease did not occur after transplantation; D. Available allogeneic hematopoietic stem cell transplant donors.\n\n-Adequate organ function: A. 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) ≥ 45%;\n\n* Women of child-bearing potential and all male participants must use effective methods of contraception for at least 12 months after infusion.;\n* Informed Consent\u002FAssent: All subjects must have the ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Central nervous system involved;\n* Patients who received the following anti-tumor therapies prior to infusion:\n\nA. Systemic use of hormones within 3 days prior to infusion (except for patients with inhaled corticosteroids); B. Systemic anti-tumor therapy within 2 weeks or within 5 drug half-lives (whichever is shorter); C. Radiotherapy within 4 weeks; D. DLI within 6 weeks; E. Intrathecal injection within 1 week; F. Received CAR-T, CAR-NK or other modified cell therapy within 6 months;\n\n* 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.\n* History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines;\n* Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment;\n* Women who are pregnant (urine\u002Fblood pregnancy test positive) or lactating;\n* Suffering from a serious autoimmune disease or immunodeficiency disease;\n* Known alcohol dependence or drug dependence;\n* According to the investigator\\'s judgment, the patient has other unsuitable grouping conditions.","ALL","18 Years",{"count":63,"type":64},12,"ESTIMATED","INTERVENTIONAL",[67],"PHASE1","This is a single-centre, single-arm, open-label, early clinical study to evaluate the safety, tolerability and preliminary efficacy of donor NK cells injection combined with low-dose interleukin-2 in the treatment of acute myeloid leukemia (AML) relapse after allogeneic hematopoietic stem cell transplantation (allo-HSCT).",[70,71,72],"Acute Myeloid Leukemia (AML)","Acute Myeloid Leukemia (AML) Relapse","NK Cell",[74,75,76,17],"AML","relapse","allogeneic hematopoietic stem cell transplantation.","2026-08-03",{"date":79,"type":80},"2026-08-05","ACTUAL",{"date":82,"type":80},"2025-11-01",{"date":84,"type":64},"2027-06-30",{"name":5,"class":6},1]