[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549978":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":40,"studyPopulation":33,"armGroups":41,"interventions":48,"overallOfficials":53,"centralContacts":58,"locations":33,"responsibleParty":64,"collaborators":66,"id":70,"slug":33,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":33,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":33,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":90,"whyStopped":33,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":33},{"fullName":5,"class":6},"Nuwacell Biotechnologies Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":33},[9,13],{"measure":10,"description":11,"timeFrame":12},"Dose-Limiting Toxicity(DLT)","Number of participants with Dose-limiting toxicity in 28 days after first infusion","4 weeks after initial infusion",{"measure":14,"description":15,"timeFrame":16},"Adverse Event(AE) or Serious Adverse Event(SAE)","Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0","From the date of initial infusion to a year after initial infusion",[18,22,25,29],{"measure":19,"description":20,"timeFrame":21},"Maximum plasma concentration(Cmax)","Maximum plasma concentration of NCR300 in peripheral blood","2 hours before initial infusion;4 hours ,24 hous, 3 Days after initial infusion.2 hours before second infusion; 24 hous, 3 Days after second infusion.",{"measure":23,"description":24,"timeFrame":21},"Time after doing at which maximun plasma concentration is reached(Tmax)","Time after doing at which maximun plasma concentration of NCR300 in peripheral blood is reached",{"measure":26,"description":27,"timeFrame":28},"Cumulative Incidence of Relapse(CIR)","The proportion of patients with hematological recurrence within 6 months after initial infusion to all patients","6 Months After Initial Infusion",{"measure":30,"description":31,"timeFrame":32},"Minimal Residual Disease(MRD)","Changes in MRD before and after treatment","From the date of screening to a year after initial infusion",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"NA","SINGLE_GROUP","PREVENTION",{"masking":39,"maskingDescription":33,"whoMasked":33},"NONE","This is an open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability and preliminary efficacy of NCR300 injection.",[42],{"label":43,"type":44,"description":45,"interventionNames":46},"NCR300 injection","EXPERIMENTAL","Cohort1: Low dose NCR300 injection; Cohort2: Mid-low dose NCR300 injection; Cohort3: Mid-high dose NCR300 injection; Cohort4: High dose NCR300 injection.",[47],"Biological: NCR300 injection",[49],{"type":50,"name":43,"description":51,"armGroupLabels":52,"otherNames":33},"BIOLOGICAL","Subjects will receive at least 1 cycle of NCR300 injection.",[43],[54],{"name":55,"affiliation":56,"role":57},"Zhao Wang, Doctor","Capital Medical University","PRINCIPAL_INVESTIGATOR",[59],{"name":60,"role":61,"phone":62,"phoneExt":33,"email":63},"Xiaowen Gong","CONTACT","15221195602","xwgong@nuwacell.com",{"type":65,"investigatorFullName":33,"investigatorTitle":33,"investigatorAffiliation":33,"oldNameTitle":33,"oldOrganization":33},"SPONSOR",[67],{"name":68,"class":69},"Beijing Friendship Hospital","OTHER","100549978",false,"NCT06441084","A Trial to Evaluate the Safety and Efficacy of NCR300 in Preventing Recurrence of Acute Myeloid Leukemia（AML) After Transplantation","A Phase I or II Clinical Trial Evaluating the Safety and Efficacy of NCR300 Injection in Preventing Recurrence of Acute Myeloid Leukemia After Allogeneic Blood Stem Cell Transplantation","Inclusion Criteria:\n\n1.Subjects who understand and voluntarily sign the Informed Consent Form(ICF);\n\n2.18-65years;\n\n3.Clinical diagnosis of AML;\n\n4.Accepted allogeneic blood stem cell transplantation within 60 to 28 days prior before initial infusion;\n\n5.Complete donor chimerism and with high-risk recurrence factors prior to transplantation , or bone marrow examination shows positive MRD；\n\n6.Have already recovered from the adverse reactions of previous treatment；\n\n7.Having appropriate organ functions；\n\n8.Eastern Cooperative Oncology Group(ECOG)\\\u003C3;\n\n9.Subjects who are able to comply with contraceptives from the study period to 6 months after the end of this study;\n\nExclusion Criteria:\n\n1. Bone marrow examination shows hematological recurrence;\n2. Have malignant tumors within 5 years before screening;\n3. Subjects with acute promyelocytic leukemia(APL);\n4. Subjects with severe respiratory diseases;\n5. Subjects with clear history of neurological or psychiatric disorders in the past;\n6. Active central nervous system involvement；\n7. HIV(human immunodeficiency virus) antibody positive,treponema pallidum(TP) antibody positive.Have active hepatitis B or hepatitis C;\n8. Allergies to NCR300 or its excipients;\n9. Subjects with active cardiovascular and cerebrovascular diseases;\n10. Received organ transplantation or planned transplantation；\n11. Received other treatment drugs after transplantation；\n12. Graft-Versus-Host Disease (GVHD)\\>II grades;\n13. Subjects with active nervous system autoimmune or inflammatory diseases;\n14. Expected survival period within 3 months;\n15. Have alcohol or drug addiction or with a clear history of mental disorders or with a history of drug abuse or drug use of psychotropic substances;\n16. Having mental illness；\n17. Having uncontrollable active infections;\n18. Subjects whose state is not suitable for entering the study;\n19. Other situations determined by investigator that it is not suitable to enter the study.","ALL","18 Years","65 Years",{"count":80,"type":81},15,"ESTIMATED","INTERVENTIONAL",[84],"PHASE1","A Trial to Evaluate the Safety and Efficacy of iNK in the Treatment of Subjects for Preventing Recurrence of Acute Myeloid Leukemia After Allogeneic Blood Stem Cell Transplantation.",[87],"Acute Myeloid Leukemia",[89],"iNK","NOT_YET_RECRUITING","2024-06-02",{"date":93,"type":94},"2024-06-04","ACTUAL",{"date":96,"type":81},"2024-06-30",{"date":98,"type":81},"2031-12-31",{"name":5,"class":6}]