[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602318":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":34,"locations":40,"responsibleParty":121,"collaborators":28,"id":123,"slug":124,"hasResults":125,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":28,"eligibilityCriteria":129,"healthyVolunteers":125,"sex":130,"minAge":131,"maxAge":28,"enrollmentInfo":132,"targetDuration":28,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":28,"overallStatus":43,"whyStopped":28,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":154},{"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",[41,60,75,91,106],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"City of Hope","RECRUITING","Duarte","California","91010","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-117.97729,34.13945,{"lat":53,"lon":52},[56],{"name":57,"role":37,"phone":58,"phoneExt":28,"email":59},"Elizabeth Budde, MD","626-218-2405","ebudde@coh.org",{"facility":61,"status":43,"city":62,"state":63,"zip":64,"country":47,"countryCode":48,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"Washington University School of Medicine","St Louis","Missouri","63110",{"type":50,"coordinates":66},[67,68],-90.19789,38.62727,{"lat":68,"lon":67},[71],{"name":72,"role":37,"phone":73,"phoneExt":28,"email":74},"Anne Fischer","314-362-3021","afischer@wustl.edu",{"facility":76,"status":43,"city":77,"state":78,"zip":79,"country":47,"countryCode":48,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Roswell Park Cancer Institute","Buffalo","New York","14263",{"type":50,"coordinates":81},[82,83],-78.87837,42.88645,{"lat":83,"lon":82},[86],{"name":87,"role":37,"phone":88,"phoneExt":89,"email":90},"Francisco Hernandez, MD","716-845-2300","1359","Francisco.Hernandez@RoswellPark.org",{"facility":92,"status":43,"city":93,"state":94,"zip":95,"country":47,"countryCode":48,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Tennessee Oncology","Nashville","Tennessee","37203",{"type":50,"coordinates":97},[98,99],-86.78444,36.16589,{"lat":99,"lon":98},[102],{"name":103,"role":37,"phone":104,"phoneExt":28,"email":105},"Michael Byrne, DO","888-550-2835","mbyrne@tnonc.com",{"facility":107,"status":43,"city":108,"state":109,"zip":110,"country":47,"countryCode":48,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Fred Hutchinson Cancer Center","Seattle","Washington","98109",{"type":50,"coordinates":112},[113,114],-122.33207,47.60621,{"lat":114,"lon":113},[117],{"name":118,"role":37,"phone":119,"phoneExt":28,"email":120},"Ajay Gopal, MD","206-606-2037","agopal@uw.edu",{"type":122,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100602318","phase-1-this-is-a-phase-1-study-to-evaluate-the-safety-of-ltz-301-in-patients-with-non-hodgkin-lymphoma-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":133,"type":134},42,"ESTIMATED","INTERVENTIONAL",[137],"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",[140,141,142,143,144],"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":147,"type":148},"2026-02-10","ACTUAL",{"date":150,"type":148},"2026-01-29",{"date":152,"type":134},"2028-02",{"name":5,"class":6},5]