[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04669171":3,"trial-entities:NCT04669171":218,"trial-summary:NCT04669171":222},{"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":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":30,"interventions":33,"primary_outcomes":56,"secondary_outcomes":67,"sex":75,"minimum_age":76,"maximum_age":77,"healthy_volunteers":78,"eligibility_criteria":79,"std_ages":83,"locations":86,"central_contacts":203,"overall_officials":212,"references":216,"see_also_links":217},"NCT04669171","EONHL1-20","A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma","A Global Multicenter Phase 1\u002F2 Trial of EO2463, a Novel Microbial-Derived Peptide Therapeutic Vaccine, as Monotherapy, and in Combination With Lenalidomide and Rituximab, for Treatment of Patients With Indolent Non-Hodgkin's Lymphoma","RECRUITING","2034-05-30","2026-01","2026-01-30","2021-07-05","Enterome","INDUSTRY",true,"The purpose of this study is to define the recommended Phase 2 Dose, safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 during monotherapy and in combination with lenalidomide and\u002For rituximab in patients with indolent NHL","EO2463 Is an innovative cancer peptide therapeutic vaccine based on the homologies between tumor associated antigens and microbiome-derived peptides that will be administered alone and in combination with lenalidomide, rituximab, and lenalidomide\u002Frituximab to generate safety and preliminary efficacy data in patients with indolent NHL",[19,20],"Follicular Lymphoma","Marginal Zone Lymphoma",[19,20,22,23,24],"Rituximab","Lenalidomide","Peptide-based immunotherapy","INTERVENTIONAL","TREATMENT",[28,29],"PHASE1","PHASE2",{"count":31,"type":32},80,"ESTIMATED",[34,43,50],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BIOLOGICAL","EO2463","Multiple dose of EO2463",[39,40,41,42],"Cohort 1","Cohort 2","Cohort 3","Cohort 4",{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"DRUG","lenalidomide","D1-21 of 4-weekly cycles",[39,42],[49],"Revlimid",{"type":35,"name":51,"description":52,"armGroupLabels":53,"otherNames":54},"rituximab","Multiple doses of rituximab",[39,41,42],[55],"MabThera",[57,61,64],{"measure":58,"description":59,"timeFrame":60},"Phase 1: Recommended Phase 2 Dose | Adverse Events Assessment |","Incidences of adverse events, Treatment-Emergent Adverse events, Serious Adverse Events, Deaths, and Laboratory Abnormalities Using the National Cancer Institute-Common Terminology Criteria for Adverse events (NCI-CTCAE) V5.0.","Up to 24 months",{"measure":62,"description":63,"timeFrame":60},"Phase 2: Overall Response Rate","Overall Response Rate According to the Lugano Classification 2014 during EO2463 Monotherapy",{"measure":65,"description":66,"timeFrame":60},"Phase 2: Complete Response Rate","Complete remission (CR)-rate according to the Lugano Classification 2014 during therapy with the combination of EO2463\u002Flenalidomide\u002Frituximab.",[68,71],{"measure":69,"description":70,"timeFrame":60},"Assessment of the Immunogenicity in Relation to OMP72, OMP64, OMP65, OMP66, and UCP2 that Compose EO2463","Immunogenicity will be assessed by interferon-Gamma (IFN-Γ) enzyme-Linked immunospot , and\u002For by intracellular cytokines staining, and\u002For multimers staining assays.",{"measure":72,"description":73,"timeFrame":74},"Evaluation of Overall Survival","The time interval from the date of first study treatment administration to the date of death due to any cause","Up to 7 years after last patient enrolled","ALL","18 Years",null,false,{"inclusion":80,"exclusion":81,"raw_text":82},[],[],"Inclusion Criteria:\n\n1. For inclusion in Cohorts 1 and 4 patients should have relapsed\u002Frefractory, biopsy-proven grade 1, 2 or 3A, FL or MZL, ECOG performance status 0 to 2, and have received at least one prior line of treatment. For inclusion in Cohort 4b the above applies except that patients with FL, and not patients with MZL, will be eligible for enrollment.\n2. For inclusion in Cohort 2 patients should have newly diagnosed, previously untreated (radiotherapy as only prior treatment is allowed), biopsy-proven grade 1, 2 or 3A, FL or MZL. ECOG performance status 0 or 1, low tumor burden by Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria, and not be in need of standard of care therapy according to the assessment of the treating physician.\n3. For inclusion in Cohort 3 patients should have newly diagnosed, previously untreated (radiotherapy as only prior treatment is allowed), biopsy-proven grade 1, 2 or 3A, FL or MZL. ECOG performance status 0 or 1, low tumor burden by GELF criteria and be in need of therapy according to the assessment of the treating physician.\n4. Patients with an age ≥ 18 years old.\n5. Patients who are human leukocyte antigen (HLA)-A2 positive.\n6. Patients should have radiologically measurable disease with a lymph node or tumor mass greater than or equal to 1.5 cm in at least one dimension.\n7. Males or non-pregnant, non-lactating, females.\n8. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.\n9. Patients having received the information sheet and who have provided written informed consent prior to any study-related procedures.\n\nExclusion Criteria:\n\n1. Patients treated with dexamethasone \\> 2 mg\u002Fday or equivalent (i.e. 13 mg\u002Fday of prednisone, or 53 mg\u002Fday of hydrocortisone) within 14 days before the first EO2463 administration, unless required to treat an adverse event.\n2. Patients with grade 3B FL or transformation to an aggressive lymphoma subtype.\n3. Patients with only one prior treatment and a high-risk profile as defined by first progression of disease within 24 months of diagnosis (the exclusion is not applicable for patients with more than one prior line treatment).\n4. Patients with prior exposure to EO2463.\n5. Patients treated with immunotherapy (meaning immunostimulatory or immunosuppressive therapy; beside excluded, or allowed, compounds per other inclusion\u002Fexclusion criteria specifications), radionuclide therapy, radiotherapy, cytoreductive therapy, or received treatment with any other investigational agent within 28 days before the first EO2463 administration.\n6. Patients to be included in Cohorts 1 and 4, and who have received rituximab or other B cell ablation therapy within 8 weeks of start of study treatment.\n7. Patients to be included in Cohorts 4, who received prior CAR T-cell therapy and progressed within 6 months after this therapy.\n8. Patients with abnormal laboratory values.\n9. Patients with persistent Grade 3 or 4 toxicities.\n10. Uncontrolled central nervous system (CNS) metastasis.\n11. Other malignancy or prior malignancy with a disease-free interval of less than 3 years.\n12. Patients with clinically significant disease.\n13. Patients with suspected autoimmune or active autoimmune disorder or known history of an autoimmune neurologic condition (e.g. Guillain-Barré syndrome).\n14. Patients with history of solid organ transplantation or allogeneic hematopoietic stem cell transplantation.\n15. Pregnant and breastfeeding patients.\n16. Patients with history or presence of human immunodeficiency virus and\u002For potentially active hepatitis B virus\u002Fhepatitis C virus infection.",[84,85],"ADULT","OLDER_ADULT",[87,100,111,121,132,142,150,159,167,177,186,194],{"facility":88,"status":8,"city":89,"state":90,"zip":91,"country":92,"contacts":93,"geoPoint":97},"Dana Farber Cancer Institute","Boston","Massachusetts","02215","United States",[94],{"name":95,"role":96},"Reid Merryman, Dr","CONTACT",{"lat":98,"lon":99},42.35843,-71.05977,{"facility":101,"status":8,"city":102,"state":103,"zip":104,"country":92,"contacts":105,"geoPoint":108},"Mayo Clinic","Rochester","Minnesota","55905",[106],{"name":107,"role":96},"Jose Caetano Villasboas Bisneto, Dr",{"lat":109,"lon":110},44.02163,-92.4699,{"facility":112,"status":8,"city":102,"state":113,"zip":114,"country":92,"contacts":115,"geoPoint":118},"University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center)","New York","14642",[116],{"name":117,"role":96},"Danielle Wallace, Dr",{"lat":119,"lon":120},43.15478,-77.61556,{"facility":122,"status":8,"city":123,"state":124,"zip":125,"country":92,"contacts":126,"geoPoint":129},"University of Washington-Seattle Cancer Care Alliance","Seattle","Washington","98109",[127],{"name":128,"role":96},"Stephen Smith, Dr",{"lat":130,"lon":131},47.60621,-122.33207,{"facility":133,"status":8,"city":134,"country":135,"contacts":136,"geoPoint":139},"CHU d'Amiens-Picardie - Hopital SUD","Amiens","France",[137],{"name":138,"role":96},"Jean-Pierre Marolleau, Dr",{"lat":140,"lon":141},49.9,2.3,{"facility":143,"status":144,"city":145,"country":146,"geoPoint":147},"University of Bologna","WITHDRAWN","Bologna","Italy",{"lat":148,"lon":149},44.49381,11.33875,{"facility":151,"status":8,"city":152,"country":146,"contacts":153,"geoPoint":156},"IRCCS Policlinico San Matteo Foundation - University of Pavia","Naples",[154],{"name":155,"role":96},"Antonio Pinto, Dr",{"lat":157,"lon":158},40.85216,14.26811,{"facility":151,"status":8,"city":160,"country":146,"contacts":161,"geoPoint":164},"Pavia",[162],{"name":163,"role":96},"Luca Arcaini, Dr",{"lat":165,"lon":166},45.19205,9.15917,{"facility":168,"status":8,"city":169,"country":170,"contacts":171,"geoPoint":174},"University Hospital Vall d'Hebron, Institute of Oncology","Barcelona","Spain",[172],{"name":173,"role":96},"Francisco Bosch Albareda, Dr",{"lat":175,"lon":176},41.38879,2.15899,{"facility":178,"status":8,"city":179,"country":170,"contacts":180,"geoPoint":183},"Clinica Universidad de Navarra","Madrid",[181],{"name":182,"role":96},"Carlos Grande, Dr",{"lat":184,"lon":185},40.4165,-3.70256,{"facility":178,"status":8,"city":187,"country":170,"contacts":188,"geoPoint":191},"Pamplona",[189],{"name":190,"role":96},"Carlos Grande Garcia, Dr",{"lat":192,"lon":193},42.81687,-1.64323,{"facility":195,"status":8,"city":196,"country":170,"contacts":197,"geoPoint":200},"Hospital Clinico Universitario de Salamanca","Salamanca",[198],{"name":199,"role":96},"Norma C Gutierrez, Dr",{"lat":201,"lon":202},40.42972,-3.67975,[204,208],{"name":205,"role":96,"phone":206,"email":207},"Jan Fagerberg, MD, PhD","+32 3 205 55 55","medicalmonitoring-hem@enterome.com",{"name":209,"role":96,"phone":210,"email":211},"Karlijn Kroon, MD","+33 611300589","kkroon-ext@enterome.com",[213],{"name":214,"affiliation":13,"role":215},"Jan Fagerberg, MD","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":219,"biomarkers":220},[19,20],[221],"HLA Class I Histocompatibility Antigen, A-2 Alpha Chain",{"nct_id":4,"found":15,"summary":223,"prompt_version":233},{"design":224,"status":225,"heading":226,"summary":227,"follow_up":228,"word_count":229,"commitments":230,"compensation":231,"drugs_mentioned":232},"This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 80 participants, but the phase of the study is not specified.","completed","EO2463 for Indolent Non-Hodgkin Lymphoma","This study is testing a new vaccine called EO2463 for people with indolent non-Hodgkin lymphoma (a slow-growing type of blood cancer), specifically follicular lymphoma or marginal zone lymphoma. Researchers want to see how safe EO2463 is and how well it works, both by itself and when given with other approved medicines like lenalidomide and\u002For rituximab. You might be able to join if you are 18 or older, have follicular lymphoma or marginal zone lymphoma that has come back or not responded to at least one previous treatment, and have a good general health status (ECOG performance status 0-2). The study will look at how many people respond to the treatment and how many have a complete response (meaning the cancer is no longer detectable) over 24 months. The study plans to enroll 80 participants, but its current status is unclear.","Researchers will assess adverse events and treatment responses for up to 24 months.",140,"Not specified in the trial record.","Not stated in the trial record.",[36,45,51],"v2"]