[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05685173":3,"trial-entities:NCT05685173":261,"trial-summary:NCT05685173":265},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":44,"secondary_outcomes":60,"sex":89,"minimum_age":90,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":91,"std_ages":95,"locations":98,"central_contacts":249,"overall_officials":255,"references":259,"see_also_links":260},"NCT05685173","R5837-ONC-2019","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)","RECRUITING","2030-01-13","2026-05","2026-05-19","2023-04-20","Regeneron Pharmaceuticals","INDUSTRY",false,"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)",null,[19],"B-cell Non-Hodgkins Lymphoma (B-NHL)",[21,22],"Aggressive B-Cell Non-Hodgkin Lymphomas","Relapsed or Refractory","INTERVENTIONAL","TREATMENT",[26],"PHASE1",{"count":28,"type":29},107,"ESTIMATED",[31,41],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":38},"DRUG","Odronextamab","Administered per the protocol",[36,37],"Dose escalation portion","Dose expansion portion",[39,40],"REGN1979","Ordspono™",{"type":32,"name":42,"description":34,"armGroupLabels":43},"REGN5837",[36,37],[45,49,53,55,58],{"measure":46,"description":47,"timeFrame":48},"Incidence of Dose Limiting Toxicities (DLTs) of REGN5837 in combination with odronextamab","A DLT is defined as any non-haematologic and haematologic toxicity, as defined in the protocol, unless the event is clearly attributable to the underlying disease or to an extraneous cause (including concomitant medications).","From Cycle 2, Day 1 to Cycle 2, Day 21 (each induction cycle is 21 days)",{"measure":50,"description":51,"timeFrame":52},"Incidence of Treatment-Emergent Adverse Events (TEAEs) of REGN5837 in combination with odronextamab","Treatment-emergent adverse events (TEAEs) are defined as those AEs that newly occurred or worsened during the on-treatment period and any treatment-related serious adverse events (SAEs) that occurred during the post-treatment period.","Up to approximatively 5 years",{"measure":54,"description":51,"timeFrame":52},"Severity of TEAEs of REGN5837 in combination with odronextamab",{"measure":56,"description":57,"timeFrame":52},"Incidence of Adverse Events of Special Interest (AESIs) of REGN5837 in combination with odronextamab","An AESI (serious or non-serious) is one of scientific and medical concern specific to the sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the sponsor can be appropriate.",{"measure":59,"description":57,"timeFrame":52},"Severity of AESIs of REGN5837 in combination with odronextamab",[61,64,66,68,70,72,74,77,80,83,86],{"measure":62,"timeFrame":63},"Concentrations of REGN5837 in the serum","Up to 90 days post last study drug administration",{"measure":65,"timeFrame":63},"Concentrations of odronextamab in the serum",{"measure":67,"timeFrame":63},"Occurrence of Anti-Drug Antibodies (ADAs) to REGN5837",{"measure":69,"timeFrame":63},"Occurrence of ADAs to odronextamab",{"measure":71,"timeFrame":63},"Magnitude of ADAs to REGN5837",{"measure":73,"timeFrame":63},"Magnitude of ADAs to odronextamab",{"measure":75,"description":76,"timeFrame":52},"Objective Response Rate (ORR) according to the Lugano Classification of response","The ORR is defined as the proportion of patients who achieve a best overall response CR or PR during or following study treatment according to the Lugano Classification based on local investigator review.",{"measure":78,"description":79,"timeFrame":52},"Complete Response (CR) according to the Lugano Classification of response","The CR rate is defined as the proportion of patients who achieve a best overall response CR during or following study treatment according to the Lugano Classification based on local investigator review.",{"measure":81,"description":82,"timeFrame":52},"Overall Survival (OS)","OS is measured from the start of study treatment until death due to any cause.",{"measure":84,"description":85,"timeFrame":52},"Progression Free Survival (PFS) according to the Lugano Classification of response","PFS is defined as the time from the start of study treatment until the first date of progressive disease, or death due to any cause, whichever occurs first, based on local investigator review.",{"measure":87,"description":88,"timeFrame":52},"Duration of Response (DoR) according to the Lugano Classification of response","DOR is defined for responders (patients with a best overall response of CR or PR). It is the time from the date of the first documented CR or PR until the date of the first date of progressive disease, or death due to any cause, whichever occurs first, based on local investigator review.","ALL","18 Years",{"inclusion":92,"exclusion":93,"raw_text":94},[],[],"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",[96,97],"ADULT","OLDER_ADULT",[99,108,115,123,131,135,143,150,154,162,171,178,186,195,202,210,217,226,234,242],{"facility":100,"status":8,"city":101,"state":102,"zip":103,"country":104,"geoPoint":105},"City of Hope","Duarte","California","91010","United States",{"lat":106,"lon":107},34.13945,-117.97729,{"facility":109,"status":8,"city":110,"state":102,"zip":111,"country":104,"geoPoint":112},"University of California Los Angeles (UCLA) Medical Center","Santa Monica","90404",{"lat":113,"lon":114},34.01949,-118.49138,{"facility":116,"status":8,"city":117,"state":118,"zip":119,"country":104,"geoPoint":120},"Norton Cancer Institute","Louisville","Kentucky","40207",{"lat":121,"lon":122},38.25424,-85.75941,{"facility":124,"status":8,"city":125,"state":126,"zip":127,"country":104,"geoPoint":128},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"lat":129,"lon":130},42.35843,-71.05977,{"facility":132,"status":8,"city":125,"state":126,"zip":133,"country":104,"geoPoint":134},"Harvard Medical School - Beth Israel Deaconess Medical Center","02215",{"lat":129,"lon":130},{"facility":136,"status":8,"city":137,"state":138,"zip":139,"country":104,"geoPoint":140},"Rutgers Cancer Institute of New Jersey","New Brunswick","New Jersey","08901",{"lat":141,"lon":142},40.48622,-74.45182,{"facility":144,"status":8,"city":145,"state":145,"zip":146,"country":104,"geoPoint":147},"NYU Langone Health Perlmutter Cancer Center","New York","10016",{"lat":148,"lon":149},40.71427,-74.00597,{"facility":151,"status":8,"city":145,"state":145,"zip":152,"country":104,"geoPoint":153},"Icahn School of Medicine at Mount Sinai","10029",{"lat":148,"lon":149},{"facility":155,"status":8,"city":156,"state":157,"zip":158,"country":104,"geoPoint":159},"UT Southwestern","Dallas","Texas","75390",{"lat":160,"lon":161},32.78306,-96.80667,{"facility":163,"status":8,"city":164,"state":165,"zip":166,"country":167,"geoPoint":168},"CHU de Bordeaux","Talence","New Aquitaine","33404","France",{"lat":169,"lon":170},44.80849,-0.58915,{"facility":172,"status":8,"city":173,"zip":174,"country":167,"geoPoint":175},"Hopital Saint Louis","Paris","75010",{"lat":176,"lon":177},48.85341,2.3488,{"facility":179,"status":8,"city":180,"state":181,"zip":182,"country":167,"geoPoint":183},"Gustave Roussy","Villejuif","Île-de-France Region","94800",{"lat":184,"lon":185},48.7939,2.35992,{"facility":187,"status":8,"city":188,"state":189,"zip":190,"country":191,"geoPoint":192},"Erasmus Medical Center Rotterdam","Rotterdam","South Holland","3015","Netherlands",{"lat":193,"lon":194},51.9225,4.47917,{"facility":196,"status":8,"city":197,"zip":198,"country":191,"geoPoint":199},"Amsterdam University Medical Centre, location AMC","Amsterdam","1100AZ",{"lat":200,"lon":201},52.37403,4.88969,{"facility":203,"status":8,"city":204,"zip":205,"country":206,"geoPoint":207},"Hospital Vall d'Hebron","Barcelona","08035","Spain",{"lat":208,"lon":209},41.38879,2.15899,{"facility":211,"status":8,"city":212,"zip":213,"country":206,"geoPoint":214},"University Hospital and Research Institute","Madrid","28041",{"lat":215,"lon":216},40.4165,-3.70256,{"facility":218,"status":8,"city":219,"state":220,"zip":221,"country":222,"geoPoint":223},"Royal Cornwall Hospitals NHS Trust, Royal Cornwall Hospital","Truro","Cornwall","TR1 3LJ","United Kingdom",{"lat":224,"lon":225},50.26526,-5.05436,{"facility":227,"status":8,"city":228,"state":229,"zip":230,"country":222,"geoPoint":231},"Southampton General Hospital","Southampton","Hampshire","SO16 6YD",{"lat":232,"lon":233},50.90395,-1.40428,{"facility":235,"status":8,"city":236,"state":237,"zip":238,"country":222,"geoPoint":239},"Western General Hospital","Edinburgh","Scotland","EH4 2XU",{"lat":240,"lon":241},55.95206,-3.19648,{"facility":243,"status":8,"city":244,"zip":245,"country":222,"geoPoint":246},"The Christie NHS Foundation Trust","Manchester","M20 4BX",{"lat":247,"lon":248},53.48095,-2.23743,[250],{"name":251,"role":252,"phone":253,"email":254},"Clinical Trials Administrator","CONTACT","844-734-6643","clinicaltrials@regeneron.com",[256],{"name":257,"affiliation":13,"role":258},"Clinical Trial Management","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":262,"biomarkers":264},[263],"B-Cell Non-Hodgkin Lymphoma",[],{"nct_id":4,"found":266,"summary":267,"prompt_version":277},true,{"design":268,"status":269,"heading":270,"summary":271,"follow_up":272,"word_count":273,"commitments":274,"compensation":275,"drugs_mentioned":276},"This is an interventional study with two parts: first, finding a safe dose, and then, testing how well that dose works. It plans to enroll about 107 adult participants.","completed","REGN5837 and Odronextamab for Aggressive B-cell Non-Hodgkin Lymphomas","This study is testing a combination of two experimental drugs, REGN5837 and odronextamab, for adults with aggressive B-cell Non-Hodgkin Lymphoma (B-NHL). You might be able to join if your lymphoma has progressed after at least two previous treatments, including an anti-CD20 antibody and an alkylating agent, and you have measurable disease. The main goal is to find a safe dose of REGN5837 when given with odronextamab, and then to see how well this combination works. Researchers will also track any side effects and how your body handles the drugs. The study is looking to enroll about 107 participants.","You would be followed for potential side effects for up to approximately 5 years after treatment.",98,"Not specified in the trial record.","Not stated in the trial record.",[33,42],"v2"]