[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639057":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":35,"centralContacts":35,"locations":49,"responsibleParty":69,"collaborators":35,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":35,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":35,"enrollmentInfo":80,"targetDuration":35,"studyType":83,"phases":84,"briefSummary":87,"conditions":88,"keywords":35,"overallStatus":52,"whyStopped":35,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Masonic Cancer Center, University of Minnesota","OTHER",[8,17,21,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Level Cohort -1","EXPERIMENTAL","Safety dose level. \\\u003C 1 x 10\\^8 Total Nucleated Cells (TNC) of AdaptNK product administered intravenously (IV).",[13,14,15,16],"Biological: AdaptNK","Drug: Fludarabine","Drug: Cyclophosphamide","Drug: IL-2",{"label":18,"type":10,"description":19,"interventionNames":20},"Dose Level Cohort 1","2.4 - 3 x 10\\^8 Total Nucleated Cells (TNC) of AdaptNK product administered intravenously (IV).",[13,14,15,16],{"label":22,"type":10,"description":23,"interventionNames":24},"Dose Level Cohort 2","0.8 - 1 x 10\\^9 Total Nucleated Cells (TNC) of AdaptNK product administered intravenously (IV).",[13,14,15,16],{"label":26,"type":10,"description":27,"interventionNames":28},"Dose Level Cohort 3","2.4 - 3 x 10\\^9 Total Nucleated Cells (TNC) of AdaptNK product administered intravenously (IV).",[13,14,15,16],[30,36,41,45],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"BIOLOGICAL","AdaptNK","The NK cell product is comprised of peripheral blood (PB) leukocytes sourced from a cryopreserved pool.\n\nof third-party donors that are seropositive for cytomegalovirus (CMV+), have NK cells expressing \\>20% NKG2C and \\>30% single-self KIR and depleted from CD3+ (T-lymphocytes) and CD19+ (B-lymphocytes) cells.",[9,18,22,26],null,{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":35},"DRUG","Fludarabine","25 mg\u002Fkg administered on days -6, -5, -4, -3 and -2. Part of Lymphodepleting conditioning chemotherapy regimen.",[9,18,22,26],{"type":37,"name":42,"description":43,"armGroupLabels":44,"otherNames":35},"Cyclophosphamide","60 mg\u002Fkg administered on days -5 and -4. Part of Lymphodepleting conditioning chemotherapy regimen.",[9,18,22,26],{"type":37,"name":46,"description":47,"armGroupLabels":48,"otherNames":35},"IL-2","IL-2 at 6 million IU subcutaneously (SC) every other day (EOD) for 3 doses with Dose 1 on Day 0 (no sooner than 4 hours post cell infusion) with the last dose no later than Day +8.",[9,18,22,26],[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Mark Juckett, MD","RECRUITING","Minneapolis","Minnesota","55455","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-93.26384,44.97997,{"lat":62,"lon":61},[65],{"name":51,"role":66,"phone":67,"phoneExt":35,"email":68},"CONTACT","612-676-4200","juck0001@umn.edu",{"type":70,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100639057","phase-1-adapt-nk-for-high-risk-myeloid-diseases-as-bridge-to-allo-hsct-100639057",false,"NCT07591649","Adapt NK for High Risk Myeloid Diseases as Bridge to Allo HSCT","Safety and Efficacy of Expanded KIR-HLA Mismatched Natural Killer Cell Immunotherapy (AdaptNK) for High-Risk Myeloid Diseases as Bridge to Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* 18-74 years with Karnofsky score ≥ 70%\n* 75 years and older: KPS ≥ 70%, HCT-CI \\\u003C 5 (excluding history of solid tumor), AND not frail by Fried frailty criteria (see Appendix III)\n* HLA type C1\u002FC1 or C2\u002FC2\n\nNote: For easy determination, the definition of HLA-C ligand group assigments is included below:\n\nHLA-C1 group alleles are defined as HLA-C01, C03, C07, C08, C12, C14, C16 HLA-C2 group alleles are defined as HLA-C02, C04, C05, C06, C15, C17, C18\n\n* adequate liver, renal, pulmonary and cardiac function\n* ability to be off glucocorticoids and other immunosuppressive medications indicated for acute or chronic GVHD for at least 28 days prior to the AdaptNK cell infusion\n* There must be sufficient time between the most recent therapy and the screening bone marrow as delineated below:\n* anti-leukemic systemic cytotoxic chemotherapy - 2 weeks\n* Targeted anti-leukemic agents (FLT-3, IDH, menin inhibitors) - 3 half-lives of the medication\n* Radiotherapy - 1 week\n* donor lymphocyte infusions - 6 weeks\n* hematopoietic growth factors (filgrastim, TPO agonists, EPO) - 1 week\n* biologic therapy (monoclonal antibodies, T-cell engagers) - 2 weeks\n* Immune effector cellular therapy - 4 weeks\n* Intrathecal chemotherapy for treatment of active CNS leukemia - there must be at least two CSF samples negative for leukemia separated by one week before enrollment.\n* WBC shall be \\\u003C 25,000 before infusion. Hydroxyurea is permitted until day -3 to control excess blast proliferation. No other systemic treatment is allowed after the screening bone marrow is performed for inclusion in protocol\n* All prior treatment related toxicities should have resolved to ≤ grade 1 prior to study enrollment\n* agrees to use of adequate contraception from study enrollment to 4 months after cell infusion\n* voluntary written consent\n\nExclusion Criteria:\n\n* Myeloid neoplasms with known or strongly suspected germline background, except DDX41, TP53, or RUNX1.\n* Acute promyelocytic leukemia (APL)\n* myocardial infarction (MI) within previous 6 months of study enrollment\n* pregnant or breastfeeding\n* Active CNS involvement with AML\n* new or progressive pulmonary infiltrates\n* active autoimmune disease requiring immunosuppressive therapy\n* Preexisting inflammatory disease requiring immunosuppressive therapy\n* history of severe asthma and currently on chronic systemic medications\n* HIV-1\u002F2 positivity or hepatitis C\u002FB\n* active systemic infections requiring anti-infective treatment\n* received any investigational agent within the 14 days before the start of study treatment (1st dose of fludarabine)\n* Patients with second malignancies are excluded if they have required systemic cytotoxic chemotherapy within 1 year or if they are not in remission\n* Exception: patients that are on stable dosing of hormonal therapy (e.g. aromatase inhibitor or antiandrogen therapy) for active breast or prostate cancer for 1 year are eligible.\n* Patients with excised basal cell or squamous cell carcinoma of the skin are eligible.\n* Patients with excised carcinoma in situ of the cervix or breast are eligible.\n* Patients with untreated T1a or T1b prostate cancer are eligible.","ALL","18 Years",{"count":81,"type":82},18,"ESTIMATED","INTERVENTIONAL",[85,86],"PHASE1","PHASE2","This is a multi-institutional Phase I\u002FII study of an allogeneic KIR-HLA mismatched NK cell infusion (AdaptNK) and a short course of subcutaneous interleukin-2 (IL-2) administered after lymphodepleting chemotherapy \\[cyclophosphamide (CY)\u002Ffludarabine (FLU)\\] in patients with relapsed or refractory acute myelogenous leukemia (AML). AdaptNK is a natural killer (NK) cell product that is enriched for NK cells with an \"adaptive\", or human cytomegalovirus (CMV)-induced, phenotype.",[89,90,91],"Relapsed Adult AML","Refractory AML","Acute Myelogenous Leukemia","2026-05-15",{"date":94,"type":95},"2026-05-19","ACTUAL",{"date":97,"type":95},"2026-05-08",{"date":99,"type":82},"2035-03-01",{"name":5,"class":6},1]