[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100506873":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":24,"locations":27,"responsibleParty":75,"collaborators":24,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":24,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":24,"enrollmentInfo":86,"targetDuration":24,"studyType":89,"phases":90,"briefSummary":93,"conditions":94,"keywords":24,"overallStatus":30,"whyStopped":24,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"GI Cell, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose escalation phase: GIC-102 monotherapy","EXPERIMENTAL","* Low Dose level 1: 1 x 10\\^9 cells\n* Mid Dose level 2: 3 x 10\\^9 cells\n* High Dose level 3: 1 x 10\\^10 cells",[13],"Drug: GIC-102",{"label":15,"type":10,"description":16,"interventionNames":17},"Dose expansion phase: GIC-102 monotherapy","\\- Dose level: RP2D",[13],[19,25],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","GIC-102","GIC-102 will be administered via IV infusion 3 times at intervals of 1 week, and 28 days is defined as 1 cycle",[9],null,{"type":20,"name":21,"description":22,"armGroupLabels":26,"otherNames":24},[15],[28,45,55,65],{"facility":29,"status":30,"city":31,"state":24,"zip":24,"country":32,"countryCode":24,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"Korea University Anam Hospital","RECRUITING","Seoul","South Korea",{"type":34,"coordinates":35},"Point",[36,37],126.9784,37.566,{"lat":37,"lon":36},[40],{"name":41,"role":42,"phone":43,"phoneExt":24,"email":44},"Soo-Hyeon Lee, M.D Ph.D","CONTACT","+82 02-920-5690","soohyeon_lee@korea.ac.kr",{"facility":46,"status":30,"city":31,"state":24,"zip":24,"country":32,"countryCode":24,"cosmosGeoPoint":47,"geoPoint":49,"contacts":50},"Seoul Asan Medical center",{"type":34,"coordinates":48},[36,37],{"lat":37,"lon":36},[51],{"name":52,"role":42,"phone":53,"phoneExt":24,"email":54},"Dok-Hyun Yoon, M.D Ph.D","+82 02-3010-5940","dhyoon@amc.seoul.kr",{"facility":46,"status":56,"city":31,"state":24,"zip":24,"country":32,"countryCode":24,"cosmosGeoPoint":57,"geoPoint":59,"contacts":60},"NOT_YET_RECRUITING",{"type":34,"coordinates":58},[36,37],{"lat":37,"lon":36},[61],{"name":62,"role":42,"phone":63,"phoneExt":24,"email":64},"Jae-Lyun Lee, M.D Ph.D","+82-3010-5977","jaelyun@amc.seoul.kr",{"facility":66,"status":30,"city":31,"state":24,"zip":24,"country":32,"countryCode":24,"cosmosGeoPoint":67,"geoPoint":69,"contacts":70},"Seoul National University Hospital",{"type":34,"coordinates":68},[36,37],{"lat":37,"lon":36},[71],{"name":72,"role":42,"phone":73,"phoneExt":24,"email":74},"Youngil Koh, M.D Ph.D","+82 02-6072-5206","go01@snu.ac.kr",{"type":76,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100506873","phase-1-gic-102-intravenous-allogeneic-nk-cells-in-subjects-with-advanced-solid-cancers-and-rr-hematologic-malignancies-100506873",false,"NCT05880043","GIC-102, Intravenous Allogeneic NK Cells, in Subjects With Advanced Solid Cancers and R\u002FR Hematologic Malignancies","An Open-label, Multi-center, Dose-escalation and Expansion, Phase 1\u002F2a Study to Evaluate the Safety, Tolerability, PK\u002FPD, and Preliminary Anti-tumor Activity of GIC-102 Monotherapy in Patients With Advanced Solid Tumors, R\u002FR Non-Hodgkin Lymphoma, and Multiple Myeloma","Inclusion criteria:\n\n1. At least 19 years of age\n2. Advanced solid tumors, relapsed\u002Frefractory non-hodgkin lymphoma, and multiple myeloma\n3. At least one measurable or evaluable lesion\n4. Eastern Cooperative Oncology Group performance status 0 or 1\n5. A life expectancy of 12 weeks or more\n6. Acceptable hematological function, kidney, and liver function\n7. Subjects who sign on an informed consent form willingly\n\nExclusion Criteria:\n\n1. Clinically significant cardiovascular disease within 24 weeks\n2. Primary malignant tumor other than the indications for this study\n3. The following diseases\n\n   1. Severe infection or other uncontrolled active infectious disease requiring administration of systemic antibiotics or antivirals within 4 weeks\n   2. The New York Heart Association class III\u002FIV\n   3. Active hepatitis B virus or hepatitis C virus infection\n   4. Human immunodeficiency virus positive\n   5. Clinically significant symptoms or uncontrolled central nervous system metastasis\n4. Previously been diagnosed with immunodeficiency or need systemic corticosteroids or other systemic immunosuppressants within 2 weeks or require administration of systemic immunosuppressants during the study\n5. Received chemotherapy other than pre-conditioning within 4 weeks\n6. Underwent major surgery within 4 weeks prior or minor surgery within 2 weeks\n7. Hypersensitivity reactions to the study drug or excipients\n8. Hypersensitivity to cyclophosphamide or fludarabine\n9. Have received allogeneic cell therapy within 6 months or autologous stem cell therapy within 4 weeks\n10. Have previously received an allogeneic tissue\u002Fsolid organ transplant\n11. Have administered other investigational drug or applied other investigational medical device within 4 weeks\n12. Pregnant or lactating female subjects\n13. Male subjects who did not agree to use contraception or to maintain abstinence","ALL","19 Years",{"count":87,"type":88},50,"ESTIMATED","INTERVENTIONAL",[91,92],"PHASE1","PHASE2","This is a first-in-human trial to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor effects of GIC-102 in patients with advanced solid tumors, relapsed\u002Frefractory non-hodgkin lymphoma, and multiple myeloma.",[95,96,97],"Advanced Solid Tumors","Relapsed\u002FRefractory Non-Hodgkin Lymphoma","Relapsed\u002FRefractory Multiple Myeloma","2024-07-04",{"date":100,"type":101},"2024-07-09","ACTUAL",{"date":103,"type":101},"2023-04-28",{"date":105,"type":88},"2026-06-30",{"name":5,"class":6},4]