[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602318":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":34,"locations":40,"responsibleParty":120,"collaborators":28,"id":122,"slug":28,"hasResults":123,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":28,"eligibilityCriteria":127,"healthyVolunteers":123,"sex":128,"minAge":129,"maxAge":28,"enrollmentInfo":130,"targetDuration":28,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":28,"overallStatus":43,"whyStopped":28,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"fullName":5,"class":6},"LTZ Therapeutics, Inc.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose Escalation","EXPERIMENTAL","Subjects in this arm will participate in one (1) of eight (8) escalating defined dose level cohorts. Subjects will receive up to 54 weeks of LTZ-301 intravenously.",[13],"Biological: LTZ-301",{"label":15,"type":10,"description":16,"interventionNames":17},"Backfill Expansion","Subjects may be dosed at levels previously declared safe to further explore safety, tolerability, and clinical activity at particular dose levels.",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Expansion","A dose level will be selected to enroll additional subjects to explore safety, tolerability, and clinical activity for a selected lymphoma type.",[13],[23,29,32],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"BIOLOGICAL","LTZ-301","LTZ-301 will be dosed IV, in initial 28 day cycles. First cycle dosing is every week. Second through fifth cycles are dosed every 2 weeks. Sixth cycle and beyond are 21 day cycles, and are dosed once every 3 weeks.",[9],null,{"type":24,"name":25,"description":30,"armGroupLabels":31,"otherNames":28},"LTZ-301will be dosed IV, as above",[15],{"type":24,"name":25,"description":30,"armGroupLabels":33,"otherNames":28},[19],[35],{"name":36,"role":37,"phone":38,"phoneExt":28,"email":39},"Sherry Unabia","CONTACT","669-207-0084","sherry.unabia@ltztherapeutics.com",[41,59,74,90,105],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"City of Hope","RECRUITING","Duarte","California","91010","United States",{"type":49,"coordinates":50},"Point",[51,52],-117.97729,34.13945,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":57,"phoneExt":28,"email":58},"Elizabeth Budde, MD","626-218-2405","ebudde@coh.org",{"facility":60,"status":43,"city":61,"state":62,"zip":63,"country":47,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"Washington University School of Medicine","St Louis","Missouri","63110",{"type":49,"coordinates":65},[66,67],-90.19789,38.62727,{"lat":67,"lon":66},[70],{"name":71,"role":37,"phone":72,"phoneExt":28,"email":73},"Anne Fischer","314-362-3021","afischer@wustl.edu",{"facility":75,"status":43,"city":76,"state":77,"zip":78,"country":47,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"Roswell Park Cancer Institute","Buffalo","New York","14263",{"type":49,"coordinates":80},[81,82],-78.87837,42.88645,{"lat":82,"lon":81},[85],{"name":86,"role":37,"phone":87,"phoneExt":88,"email":89},"Francisco Hernandez, MD","716-845-2300","1359","Francisco.Hernandez@RoswellPark.org",{"facility":91,"status":43,"city":92,"state":93,"zip":94,"country":47,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Tennessee Oncology","Nashville","Tennessee","37203",{"type":49,"coordinates":96},[97,98],-86.78444,36.16589,{"lat":98,"lon":97},[101],{"name":102,"role":37,"phone":103,"phoneExt":28,"email":104},"Michael Byrne, DO","888-550-2835","mbyrne@tnonc.com",{"facility":106,"status":43,"city":107,"state":108,"zip":109,"country":47,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",{"type":49,"coordinates":111},[112,113],-122.33207,47.60621,{"lat":113,"lon":112},[116],{"name":117,"role":37,"phone":118,"phoneExt":28,"email":119},"Ajay Gopal, MD","206-606-2037","agopal@uw.edu",{"type":121,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100602318",false,"NCT07121946","This is a Phase 1 Study to Evaluate the Safety of LTZ-301 in Patients With Non-Hodgkin Lymphoma","A Phase 1, Open-label, Multicenter Study of LTZ-301 in Subjects With Relapsed\u002FRefractory Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Relapsed or refractory to at least 2 prior systemic treatment regimens\n* At least 1 bi-dimensionally measurable lesion (≥ 1.5 cm) in longest dimension\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Adequate bone marrow, cardiac, pulmonary, renal, and hepatic function\n\nExclusion Criteria:\n\n* CLL, or Richters transformation\n* Prior solid organ transplant\n* Prior allogeneic stem cell transplant\n* ASCT within 100 days prior to the first LTZ-301 administration\n* Prior CAR-T within 60 days prior to the first LTZ-301 administration\n* Current central nervous system (CNS) lymphoma\n* Known history of human immunodeficiency virus (HIV) seropositivity\n* Active autoimmune disease\n* History of clinically significant cardiovascular disease\n* symptomatic deep vein thrombosis (DVT) within 3 months of enrollment\n* History of other malignancy within 3 years prior to screening","ALL","18 Years",{"count":131,"type":132},42,"ESTIMATED","INTERVENTIONAL",[135],"PHASE1","This study is a first-in-human (FIH), Phase 1, multicenter, open-label study to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, and evaluate the preliminary anti-tumor activity of LTZ-301 administered as a single agent in adult subjects with relapsed or refractory B-cell non-Hodgkin lymphoma",[138,139,140,141,142],"Non-Hodgkin Lymphoma Refractory\u002F Relapsed","DLBCL - Diffuse Large B Cell Lymphoma","Mantle Cell Lymphoma (MCL)","Follicular Lymphoma ( FL)","Marginal Zone Lymphoma (MZL)","2026-02-06",{"date":145,"type":146},"2026-02-10","ACTUAL",{"date":148,"type":146},"2026-01-29",{"date":150,"type":132},"2028-02",{"name":5,"class":6},5]