[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100491902":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":238,"collaborators":11,"id":240,"slug":241,"hasResults":242,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":242,"sex":248,"minAge":249,"maxAge":11,"enrollmentInfo":250,"targetDuration":11,"studyType":253,"phases":254,"briefSummary":256,"conditions":257,"keywords":259,"overallStatus":43,"whyStopped":11,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":271},{"fullName":5,"class":6},"Regeneron Pharmaceuticals","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Dose escalation portion","EXPERIMENTAL",null,[13,14],"Drug: Odronextamab","Drug: REGN5837",{"label":16,"type":10,"description":11,"interventionNames":17},"Dose expansion portion",[13,14],[19,27],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Odronextamab","Administered per the protocol",[9,16],[25,26],"REGN1979","Ordspono™",{"type":20,"name":28,"description":22,"armGroupLabels":29,"otherNames":11},"REGN5837",[9,16],[31],{"name":32,"affiliation":5,"role":33},"Clinical Trial Management","STUDY_DIRECTOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Clinical Trials Administrator","CONTACT","844-734-6643","clinicaltrials@regeneron.com",[41,55,64,74,84,90,100,109,115,125,137,146,156,168,177,188,197,209,219,229],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":11},"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},{"facility":56,"status":43,"city":57,"state":45,"zip":58,"country":47,"countryCode":48,"cosmosGeoPoint":59,"geoPoint":63,"contacts":11},"University of California Los Angeles (UCLA) Medical Center","Santa Monica","90404",{"type":50,"coordinates":60},[61,62],-118.49138,34.01949,{"lat":62,"lon":61},{"facility":65,"status":43,"city":66,"state":67,"zip":68,"country":47,"countryCode":48,"cosmosGeoPoint":69,"geoPoint":73,"contacts":11},"Norton Cancer Institute","Louisville","Kentucky","40207",{"type":50,"coordinates":70},[71,72],-85.75941,38.25424,{"lat":72,"lon":71},{"facility":75,"status":43,"city":76,"state":77,"zip":78,"country":47,"countryCode":48,"cosmosGeoPoint":79,"geoPoint":83,"contacts":11},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":50,"coordinates":80},[81,82],-71.05977,42.35843,{"lat":82,"lon":81},{"facility":85,"status":43,"city":76,"state":77,"zip":86,"country":47,"countryCode":48,"cosmosGeoPoint":87,"geoPoint":89,"contacts":11},"Harvard Medical School - Beth Israel Deaconess Medical Center","02215",{"type":50,"coordinates":88},[81,82],{"lat":82,"lon":81},{"facility":91,"status":43,"city":92,"state":93,"zip":94,"country":47,"countryCode":48,"cosmosGeoPoint":95,"geoPoint":99,"contacts":11},"Rutgers Cancer Institute of New Jersey","New Brunswick","New Jersey","08901",{"type":50,"coordinates":96},[97,98],-74.45182,40.48622,{"lat":98,"lon":97},{"facility":101,"status":43,"city":102,"state":102,"zip":103,"country":47,"countryCode":48,"cosmosGeoPoint":104,"geoPoint":108,"contacts":11},"NYU Langone Health Perlmutter Cancer Center","New York","10016",{"type":50,"coordinates":105},[106,107],-74.00597,40.71427,{"lat":107,"lon":106},{"facility":110,"status":43,"city":102,"state":102,"zip":111,"country":47,"countryCode":48,"cosmosGeoPoint":112,"geoPoint":114,"contacts":11},"Icahn School of Medicine at Mount Sinai","10029",{"type":50,"coordinates":113},[106,107],{"lat":107,"lon":106},{"facility":116,"status":43,"city":117,"state":118,"zip":119,"country":47,"countryCode":48,"cosmosGeoPoint":120,"geoPoint":124,"contacts":11},"UT Southwestern","Dallas","Texas","75390",{"type":50,"coordinates":121},[122,123],-96.80667,32.78306,{"lat":123,"lon":122},{"facility":126,"status":43,"city":127,"state":128,"zip":129,"country":130,"countryCode":131,"cosmosGeoPoint":132,"geoPoint":136,"contacts":11},"CHU de Bordeaux","Talence","New Aquitaine","33404","France","FR",{"type":50,"coordinates":133},[134,135],-0.58915,44.80849,{"lat":135,"lon":134},{"facility":138,"status":43,"city":139,"state":11,"zip":140,"country":130,"countryCode":131,"cosmosGeoPoint":141,"geoPoint":145,"contacts":11},"Hopital Saint Louis","Paris","75010",{"type":50,"coordinates":142},[143,144],2.3488,48.85341,{"lat":144,"lon":143},{"facility":147,"status":43,"city":148,"state":149,"zip":150,"country":130,"countryCode":131,"cosmosGeoPoint":151,"geoPoint":155,"contacts":11},"Gustave Roussy","Villejuif","Île-de-France Region","94800",{"type":50,"coordinates":152},[153,154],2.35992,48.7939,{"lat":154,"lon":153},{"facility":157,"status":43,"city":158,"state":159,"zip":160,"country":161,"countryCode":162,"cosmosGeoPoint":163,"geoPoint":167,"contacts":11},"Erasmus Medical Center Rotterdam","Rotterdam","South Holland","3015","Netherlands","NL",{"type":50,"coordinates":164},[165,166],4.47917,51.9225,{"lat":166,"lon":165},{"facility":169,"status":43,"city":170,"state":11,"zip":171,"country":161,"countryCode":162,"cosmosGeoPoint":172,"geoPoint":176,"contacts":11},"Amsterdam University Medical Centre, location AMC","Amsterdam","1100AZ",{"type":50,"coordinates":173},[174,175],4.88969,52.37403,{"lat":175,"lon":174},{"facility":178,"status":43,"city":179,"state":11,"zip":180,"country":181,"countryCode":182,"cosmosGeoPoint":183,"geoPoint":187,"contacts":11},"Hospital Vall d'Hebron","Barcelona","08035","Spain","ES",{"type":50,"coordinates":184},[185,186],2.15899,41.38879,{"lat":186,"lon":185},{"facility":189,"status":43,"city":190,"state":11,"zip":191,"country":181,"countryCode":182,"cosmosGeoPoint":192,"geoPoint":196,"contacts":11},"University Hospital and Research Institute","Madrid","28041",{"type":50,"coordinates":193},[194,195],-3.70256,40.4165,{"lat":195,"lon":194},{"facility":198,"status":43,"city":199,"state":200,"zip":201,"country":202,"countryCode":203,"cosmosGeoPoint":204,"geoPoint":208,"contacts":11},"Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital","Truro","Cornwall","TR1 3LJ","United Kingdom","UK",{"type":50,"coordinates":205},[206,207],-5.05436,50.26526,{"lat":207,"lon":206},{"facility":210,"status":43,"city":211,"state":212,"zip":213,"country":202,"countryCode":203,"cosmosGeoPoint":214,"geoPoint":218,"contacts":11},"Southampton General Hospital","Southampton","Hampshire","SO16 6YD",{"type":50,"coordinates":215},[216,217],-1.40428,50.90395,{"lat":217,"lon":216},{"facility":220,"status":43,"city":221,"state":222,"zip":223,"country":202,"countryCode":203,"cosmosGeoPoint":224,"geoPoint":228,"contacts":11},"Western General Hospital","Edinburgh","Scotland","EH4 2XU",{"type":50,"coordinates":225},[226,227],-3.19648,55.95206,{"lat":227,"lon":226},{"facility":230,"status":43,"city":231,"state":11,"zip":232,"country":202,"countryCode":203,"cosmosGeoPoint":233,"geoPoint":237,"contacts":11},"The Christie NHS Foundation Trust","Manchester","M20 4BX",{"type":50,"coordinates":234},[235,236],-2.23743,53.48095,{"lat":236,"lon":235},{"type":239,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100491902","phase-1-a-trial-to-study-if-regn5837-in-combination-with-odronextamab-is-safe-for-adult-participants-with-aggressive-b-cell-non-hodgkin-lymphomas-100491902",false,"NCT05685173","A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas","A Phase 1 Study to Assess Safety and Tolerability of REGN5837, an Anti-CD22 x Anti-CD28 Costimulatory Bispecific Monoclonal Antibody, in Combination With Odronextamab, an Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody, in Patients With Aggressive B-Cell Non-Hodgkin Lymphomas (ATHENA-1)","ATHENA-1","Key Inclusion Criteria:\n\n1. Have documented CD20+ aggressive B-NHL, with disease that has progressed after at least 2 lines of systemic therapy containing an anti-CD20 antibody and an alkylating agent, as described in the protocol.\n2. Measurable disease on cross sectional imaging as defined in the protocol\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n4. Adequate bone marrow, renal and hepatic function as defined in the protocol\n5. Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed\n6. During dose expansion phase of the study, participant should be willing to undergo mandatory tumor biopsies, if in the opinion of the investigator, the participant has an accessible lesion that can be biopsied without significant risk to the participant.\n\nKey Exclusion Criteria:\n\n1. Prior treatments with allogeneic stem cell transplantation or solid organ transplantation, treatment with anti-CD20 x anti- CD3 bispecific antibody, such as odronextamab\n2. Diagnosis of Mantle Cell Lymphoma (MCL)\n3. Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS lymphoma, as described in the protocol\n4. Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 14 days prior to first administration of study drug, whichever is shorter, as described in the protocol\n5. Standard radiotherapy within 14 days of first administration of study drug, as described in the protocol\n6. Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or corticosteroid equivalent within 72 hours of start of odronextamab\n7. Co-morbid conditions, as described in the protocol\n8. Infections, as described in the protocol\n9. Allergy\u002Fhypersensitivity: Known hypersensitivity to both allopurinol and rasburicase\n\nNOTE: Other protocol defined inclusion \u002F exclusion criteria apply","ALL","18 Years",{"count":251,"type":252},107,"ESTIMATED","INTERVENTIONAL",[255],"PHASE1","This study is researching an experimental drug called REGN5837 in combination with another drug, odronextamab (called \"study drug\\[s\\]\"), in patients with relapsed or refractory aggressive B-cell Non-Hodgkin Lymphomas (B-NHLs).\n\nThe study has 2 parts. The aim of the first part (dose escalation) is to find a safe dose of REGN5837 when given in combination with odronextamab.\n\nThe goal of the second part (dose expansion) is to use the REGN5837 drug dose found in the first part to see how well REGN5837 in combination with odronextamab works.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drugs\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drugs (that could make the drugs less effective or could lead to side effects)",[258],"B-cell Non-Hodgkins Lymphoma (B-NHL)",[260,261],"Aggressive B-Cell Non-Hodgkin Lymphomas","Relapsed or Refractory","2026-05-18",{"date":264,"type":265},"2026-05-19","ACTUAL",{"date":267,"type":265},"2023-04-20",{"date":269,"type":252},"2030-01-13",{"name":5,"class":6},20]