[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100544345":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":33,"responsibleParty":51,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":11,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":11,"enrollmentInfo":67,"targetDuration":11,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"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,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"the First Affiliated Hospital, School of Medicine, Zhejiang University","RECRUITING","Hangzhou","Zhejiang","321000","China","CN",{"type":43,"coordinates":44},"Point",[45,46],120.16142,30.29365,{"lat":46,"lon":45},[49],{"name":50,"role":26,"phone":11,"phoneExt":11,"email":32},"Yongxian Hu",{"type":23,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"He Huang","Professor",[55],{"name":56,"class":57},"Hangzhou Qihanjiyin Biotech Co.,Ltd.","UNKNOWN","100544345","phase-1-natural-killernk-cell-therapy-targeting-cll1-or-cd33-in-acute-myeloid-leukemia-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":68,"type":69},24,"ESTIMATED","INTERVENTIONAL",[72],"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",[75],"AML, Adult",[77],"AML","2024-04-16",{"date":80,"type":81},"2024-04-18","ACTUAL",{"date":83,"type":69},"2024-04-30",{"date":85,"type":69},"2026-08-31",{"name":5,"class":6},1]