[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100565397":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":33,"responsibleParty":50,"collaborators":20,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":20,"eligibilityCriteria":58,"healthyVolunteers":55,"sex":59,"minAge":60,"maxAge":20,"enrollmentInfo":61,"targetDuration":20,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":72,"overallStatus":76,"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":20,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Beijing","Beijing Municipality","100034","China","CN",{"type":41,"coordinates":42},"Point",[43,44],116.39723,39.9075,{"lat":44,"lon":43},[47],{"name":48,"role":27,"phone":49,"phoneExt":20,"email":29},"Yujun Dong","+86 18210264969",{"type":24,"investigatorFullName":51,"investigatorTitle":52,"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* 1.Age ≥ 18 years old, no gender or race; 2.Expected survival period ≥ 3 months; 3.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; 4.The diagnosis of AML who received allo-HSCT, and met the following criteria: 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. 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. 5. 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%; 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\n* 1\\. Central nervous system involved; 2. Patients who received the following anti-tumor therapies prior to infusion: A. 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; 3. 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\n  4\\. History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines; 5. Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment; 6. Women who are pregnant (urine\u002Fblood pregnancy test positive) or lactating; 7. Suffering from a serious autoimmune disease or immunodeficiency disease; 8. Known alcohol dependence or drug dependence; 9. According to the investigator\\'s judgment, the patient has other unsuitable grouping conditions.","ALL","18 Years",{"count":62,"type":63},12,"ESTIMATED","INTERVENTIONAL",[66],"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).",[69,70,71],"Acute Myeloid Leukemia (AML)","Acute Myeloid Leukemia (AML) Relapse","NK Cell",[73,74,75,17],"AML","relapse","allogeneic hematopoietic stem cell transplantation.","NOT_YET_RECRUITING","2024-10-11",{"date":79,"type":80},"2024-10-15","ACTUAL",{"date":82,"type":63},"2024-12-01",{"date":84,"type":63},"2026-06-30",{"name":5,"class":6},1]