[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569863":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":22,"centralContacts":30,"locations":40,"responsibleParty":84,"collaborators":86,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":22,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":22,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":22,"overallStatus":43,"whyStopped":22,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"GC Cell Corporation","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1a Dose Escalation and Phase 1b Dose Expansion","EXPERIMENTAL","Dose Confirmation of GCC2005 in Relapsed or Refractory NK and T-cell Malignancies",[13,14,15],"Drug: GCC2005","Drug: Cyclophosphamide","Drug: Fludarabine",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","GCC2005","CAR-NK Cell Therapy",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Cyclophosphamide","Lymphodepleting chemotherapy",[9],{"type":18,"name":28,"description":25,"armGroupLabels":29,"otherNames":22},"Fludarabine",[9],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":22,"email":35},"HyeSung Jeon","CONTACT","+82-31-260-9059","hs_jeon@gccorp.com",{"name":37,"role":33,"phone":38,"phoneExt":22,"email":39},"Seungryel Han","+82-31-260-9771","hansr@gccorp.com",[41,60,72],{"facility":42,"status":43,"city":44,"state":22,"zip":45,"country":46,"countryCode":22,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Seoul National University Hosptial","RECRUITING","Seoul","03080","South Korea",{"type":48,"coordinates":49},"Point",[50,51],126.9784,37.566,{"lat":51,"lon":50},[54,58],{"name":55,"role":33,"phone":56,"phoneExt":22,"email":57},"Youngil Koh, MD","+82-2-2072-7217","go01@snu.ac.kr",{"name":55,"role":59,"phone":22,"phoneExt":22,"email":22},"PRINCIPAL_INVESTIGATOR",{"facility":61,"status":43,"city":44,"state":22,"zip":62,"country":46,"countryCode":22,"cosmosGeoPoint":63,"geoPoint":65,"contacts":66},"Asan Medical Center","05505",{"type":48,"coordinates":64},[50,51],{"lat":51,"lon":50},[67,71],{"name":68,"role":33,"phone":69,"phoneExt":22,"email":70},"DokHyun Yoon, MD","+82-2-3010-5940","dhyoon@amc.seoul.kr",{"name":68,"role":59,"phone":22,"phoneExt":22,"email":22},{"facility":73,"status":43,"city":44,"state":22,"zip":74,"country":46,"countryCode":22,"cosmosGeoPoint":75,"geoPoint":77,"contacts":78},"Samsung Medical Center","06351",{"type":48,"coordinates":76},[50,51],{"lat":51,"lon":50},[79,83],{"name":80,"role":33,"phone":81,"phoneExt":22,"email":82},"Won Seog Kim, MD","+82-2-2148-7390","wonseog.kim@samsung.com",{"name":80,"role":59,"phone":22,"phoneExt":22,"email":22},{"type":85,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[87],{"name":88,"class":6},"Artiva Biotherapeutics, Inc.","100569863","phase-1-phase-1-to-investigate-the-safety-tolerability-and-efficacy-of-gcc2005-in-patients-with-rr-nk-and-t-cell-malignancies-100569863",false,"NCT06699771","Phase 1 to Investigate the Safety, Tolerability, and Efficacy of GCC2005 in Patients With R\u002FR NK and T-cell Malignancies","A Phase 1, Multicenter Trial to Assess the Safety, Tolerability, and Preliminary Efficacy of GCC2005 With Lymphodepleting Chemotherapy in Treatment of Patients With Relapsed or Refractory NK and T-cell Malignancies","Inclusion Criteria:\n\n* Patients with relapsed or refractory CD5+ NK and T-cell originated malignancies (per WHO classification 2017).\n* Patients with relapsed or refractory disease previously treated with two or more lines of standard chemotherapies and there is no longer any treatment option considered as assessed by the Investigator.\n* According to the Lugano classification, patients having lesion\u002Fnodules ≥ 1 with diameter longer than 1.5 cm for nodal lesions and longer than 1.0 cm for extranodal lesions, and the boundaries are clearly shown.\n* Patient has a performance status of 0, 1, or 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status.\n* Patients who satisfy the criteria defined in the protocol.\n* Contraceptive use by men and women must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.\n\nExclusion Criteria:\n\n* Has T-ALL\u002FT-LBL or CTCL.\n* Patient with CNS lymphoma or any involvement of the CNS.\n* Patient who had a prior history of another malignancy over the last 3 years.\n* Patients who have used hematopoietic growth factor therapy within 14 days prior to Screening.\n* Patients who have had prior CAR-T or CAR-NK therapies.\n* Presence of uncontrolled fungal, bacterial, viral infection or other infection requiring IV antimicrobials for management\n* Patients with previous allogenic organ transplantation\n* Patients with previous diagnosis of primary immunodeficiency or currently undergoing therapy of primary immunodeficiency.\n* Patients with acute GvHD ≥ Grade 3 or extensive chronic GvHD within 2 weeks of lymphodepletion.\n* Patients with known active Hepatitis B or C\n* Patients with presence of Grade 2 or greater toxicity from the previous treatment.","ALL","19 Years","80 Years",{"count":100,"type":101},48,"ESTIMATED","INTERVENTIONAL",[104],"PHASE1","This is a Phase 1 (a and b), first in human (FIH), single-arm, open-label, multicenter study to evaluate the safety, tolerability and efficacy of GCC2005 in the treatment of patients with relapsed\u002Frefractory (R\u002FR) NK or T-cell malignancies who have received at least two prior lines of therapy.",[107],"Lymphoma, T-Cell","2025-04-28",{"date":110,"type":111},"2025-04-30","ACTUAL",{"date":113,"type":111},"2025-03-07",{"date":115,"type":101},"2027-08",{"name":5,"class":6},3]