[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544345":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":33,"responsibleParty":50,"collaborators":53,"id":57,"slug":11,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":11,"eligibilityCriteria":62,"healthyVolunteers":58,"sex":63,"minAge":64,"maxAge":11,"enrollmentInfo":65,"targetDuration":11,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Zhejiang University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CAR-NK cell therapy in Adult subjects with r\u002Fr AML","EXPERIMENTAL",null,[13],"Biological: iPSC-NK cells",[15],{"type":16,"name":17,"description":17,"armGroupLabels":18,"otherNames":11},"BIOLOGICAL","iPSC-NK cells",[9],[20],{"name":21,"affiliation":22,"role":23},"He Huang, MD","First Affiliated Hospital of Zhejiang University","PRINCIPAL_INVESTIGATOR",[25,29],{"name":21,"role":26,"phone":27,"phoneExt":11,"email":28},"CONTACT","+8613605714822","hehuangyu@126.com",{"name":30,"role":26,"phone":31,"phoneExt":11,"email":32},"Yongxian Hu, MD","+8615957162012","huyongxian2000@aliyun.com",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"the First Affiliated Hospital, School of Medicine, Zhejiang University","RECRUITING","Hangzhou","Zhejiang","321000","China",{"type":42,"coordinates":43},"Point",[44,45],120.16142,30.29365,{"lat":45,"lon":44},[48],{"name":49,"role":26,"phone":11,"phoneExt":11,"email":32},"Yongxian Hu",{"type":23,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"He Huang","Professor",[54],{"name":55,"class":56},"Hangzhou Qihanjiyin Biotech Co.,Ltd.","UNKNOWN","100544345",false,"NCT06367673","Natural Killer(NK) Cell Therapy Targeting CLL1 or CD33 in Acute Myeloid Leukemia","Clinical Study to Evaluate the Safety and Efficacy of iPSC -NK Cells Targeting CLL1 or CD33 in Patients With Relapsed\u002FRefractory AML","Inclusion Criteria:\n\n* ≥18 years old.\n* Confirmed diagnosis of r\u002Fr AML\n* CLL1 or CD33 expression is positive in AML blasts.\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤1 and life expectancy greater than 12 weeks.\n* Adequate organ and marrow function, as defined below:\n\n  1. Blood creatinine (Cr) ≤ 2 x ULN or calculated creatinine clearance (Cockcroft- Gault formula) ≥ 50 mL\u002Fmin;\n  2. Total bilirubin (TBIL) ≤ 2 x the ULN;\n  3. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x ULN;\n  4. International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN 6.Females of childbearing potential must have a negative serum pregnancy test. 7.Donor specific antibody (DSA) is negative: MFI \\\u003C= 2000. 8.Provision of signed and dated informed consent form (ICF).\n\nExclusion Criteria:\n\n* Allergic to drug used in this study.\n* Subjects received any antitumor therapy as follows, prior to first NK infusion:\n\n  a. Systemic steroid therapy within 3 days (except physiological replacement therapy):b. Systemic antitumor therapy within 2 weeks or at least 5 half-lives, whichever is less; c. Radiotherapy within 4 weeks; d. Donor lmphocyte infusion within 6 weeks: e. Intrathecal treatment within 1 week; f CAR-T therapy, CAR-NK therapy, or any other genetically modified cell therapy product within 6 months;\n* History of allogeneic stem cell transplantation.\n* Received the vaccine within 4 weeks pror to the first infusion andor expected to reuire vaccination from the study period to 12 weeks ater the last intusion\n* Active central nervous system Leukemia.\n* Acute Promyelocytic Leukemia (APL).\n\n  .History of other malicnant tumors, except for those who have achieved omplete remission more than 5 years after radical treatment without any sions of recurence9. History of central nervous system disease or meningeal involvement such as epilepsy, paralysis, aphasia, stroke, etc\n* Active autoimmune diseases.\n* Serious cardiovascular and cerebrovascular diseases:a. Severe heart rhythm or conduction abnormalities, corrected OT interval (OTc)\\>480 ms:h, Aute coronay sndrome conestve heat faur. aortic disection-stroke. or other orade 3 or hioher ardiovasular and cerebrovascular events within 6 months orior to firstinfusiorC, New York Heart Association (NYHA) class l or above congestive heart failure or left ventricular eiection fraction (LVEF \\\u003C50% in olor Doppler echocardiography,d. Hypertension that cannot be controlled by drug.\n* Active pulmonary infection: Sp02 90%: Pulmonary embolism, chronic obstructive pulmonary disease, or interstitial lung disease\n* Uncontrolled bacterial, fungal, or viral infection.Known HlV infection, active Hepatitis B (HBV) or Hepatitis C (HCV) infection\n* Historv of substance abuse.\n* Toxicity induced by previous therapy not recovered to s grade 2(NCI-CTCAE 5.0).15. Large suraical treatment within 4 weeks prior to first infusion, not including diagnostic biopsy.16. Pregnant\u002Fbreastfeeding women.17. nvestigator-assessed presence of any medical or social issue that are likely to interfere with study conduct or may cause increased risk to subiect","ALL","18 Years",{"count":66,"type":67},24,"ESTIMATED","INTERVENTIONAL",[70],"PHASE1","This is a phase 1, first-in-human (FIH), open-label, multicohort study to evaluate the safety, tolerability and preliminary efficacy of CLL1 or CD33 target Chimeric antigen receptor (CAR) -induced pluripotent stem cells derived NK cells in patients with relapsed\u002Frefractory AML",[73],"AML, Adult",[75],"AML","2024-04-16",{"date":78,"type":79},"2024-04-18","ACTUAL",{"date":81,"type":67},"2024-04-30",{"date":83,"type":67},"2026-08-31",{"name":5,"class":6},1]