[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03571568":3,"trial-entities:NCT03571568":366,"trial-summary:NCT03571568":373},{"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":21,"primary_purpose":22,"phases":23,"enrollment_info":26,"interventions":29,"primary_outcomes":52,"secondary_outcomes":63,"sex":77,"minimum_age":78,"maximum_age":15,"healthy_volunteers":79,"eligibility_criteria":80,"std_ages":84,"locations":87,"central_contacts":355,"overall_officials":363,"references":364,"see_also_links":365},"NCT03571568","17-BI-1206-02","A Study of BI-1206 in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell NHL","Phase 1\u002F2a Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination With Rituximab With or Without Acalabrutinib in Subjects With Indolent B-Cell Non-Hodgkin Lymphoma That Has Relapsed or is Refractory to Rituximab","RECRUITING","2026-09-30","2025-04","2025-04-24","2018-05-16","BioInvent International AB","INDUSTRY",null,"Phase 1\u002F2a Clinical Trial of BI-1206, a Monoclonal Antibody to CD32b (FcyRIIB), in Combination with Rituximab with or without Acalabrutinib in Subjects with Indolent B-Cell Non-Hodgkin Lymphoma That has Relapsed or is Refractory to Rituximab","This is a Phase 1\u002F2a, multicenter, dose escalation, consecutive-cohort, open-label trial of BI-1206 in combination with rituximab with or without acalabrutinib in subjects with indolent relapsed or refractory B-cell NHL, sub-types FL (except FL grade 3B), MZL, and MCL.\n\nPhase 2a, consists of signal seeking cohorts followed by a randomized, parallel, two-arm dose optimization.\n\nThe trial consists of 2 main parts:\n\nPhase 1\n\n\\- Dose Escalation, with two different Arms assessing IV or SC dosing of BI-1206 in combination with rituximab, with dose escalation cohorts and selection of the IV and SC doses of BI-1206 for Phase 2a\n\nPhase 2a\n\n* Dose Expansion, with one expansion cohort evaluating the selected IV dose of BI-1206 in combination with rituximab\n* Signal Seeking, assessing IV and SC dosing of BI-1206 in combination with rituximab and acalabrutinib. The Signal Seeking will consist of a Safety Run-in and an Expansion\n* Dose Optimization to select the recommended dose of BI-1206 in combination with rituximab and acalabrutinib",[19],"Indolent B-Cell Non-Hodgkin Lymphoma",[],"INTERVENTIONAL","TREATMENT",[24,25],"PHASE1","PHASE2",{"count":27,"type":28},140,"ESTIMATED",[30,40,46],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BIOLOGICAL","BI-1206","BI-1206 150 mg \u002F 225 mg Subcutaneous injection\n\nBI-1206 50 mg \u002F100 mg Intravenous infusion",[35,36,37,38,39],"BI-1206 IV Dose Escalation","BI-1206 SC Dose Escalation","Phase 2a IV Dose expansion","Phase 2a IV Signal Seeking","Phase 2a SC Signal seeking",{"type":31,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Rituximab","Rituximab 375 mg\u002Fm2, as per SmPC",[35,36,37,38,39],[45],"Ruxience",{"type":31,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Acalabrutinib","Acalabrutinib 100 mg orally as per SmPC",[38,39],[51],"Calquence",[53,57,60],{"measure":54,"description":55,"timeFrame":56},"Documenting AEs and SAEs and determining causality in relation to BI-1206 and\u002For rituximab and\u002For acalabrutinib","Assess the safety and tolerability profile of BI-1206 when administered intravenously (IV) or subcutaneously (SC) in combination with rituximab or rituximab and acalabrutinib in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL), subtypes follicular lymphoma (FL)(except FL grade 3B), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL). Assessment will be done according to National Cancer Institute (NCI-CTCAE) criteria v. 5.0.","During the 28-day treatment period on induction therapy",{"measure":58,"description":59,"timeFrame":56},"Determining the MTD of BI-1206 at the same dose level experiencing a BI-1206 or Rituximab-related or possibly related dose-limiting toxicity (DLT)","Phase 1:\n\nSelect the recommended Phase 2 dose (RP2D) by establishing the maximum tolerated dose (MTD) of BI-1206 given once weekly for 4 weeks, via IV infusion or SC injection in combination with rituximab.",{"measure":61,"description":62,"timeFrame":56},"Determine the recommended dose of BI-1206 in combination with rituximab and acalabrutinib","Phase 2a:\n\nSelect the recommended dose of BI-1206 in combination with rituximab and acalabrutinib.",[64,68,71,74],{"measure":65,"description":66,"timeFrame":67},"Evaluation of PK parameters for BI-1206","PK parameters assessed will include AUC, Cmax, time to Cmax and t1\u002F2 of BI-1206 when administered IV or SC","Up to 1 year",{"measure":69,"description":70,"timeFrame":67},"Evaluation of ADA (immunogenicity) response to BI-1206","Assess the incidence and titre of antidrug antibodies of BI-1206 in serum when administered IV or SC in combination with rituximab or rituximab and acalabrutinib.",{"measure":72,"description":73,"timeFrame":67},"Measurement of peripheral blood B-lymphocytes depletion","Evaluate the effect of BI-1206 administered IV or SC in combination with rituximab or rituximab and acalabrutinib measuring B Lymphocytes CD19+ (absolute value) as part of hematology assessment to determine the level of peripheral blood B lymphocyte depletion.",{"measure":75,"description":76,"timeFrame":67},"Assessment of overall response rate (ORR) according to the response criteria for malignant lymphoma (Cheson, 2014).","Assess possible anti-tumor activity of BI-1206 administered IV or SC in combination with rituximab or rituximab and acalabrutinib at Week 6 after first dose of BI-1206 and for subjects who continue during maintenance therapy.","ALL","18 Years",false,{"inclusion":81,"exclusion":82,"raw_text":83},[],[],"Inclusion Criteria:\n\n1. Are ≥ 18 years of age by initiation of study treatment.\n2. Have B-cell NHL proven by histology, with histological subtypes limited to follicular lymphoma (FL) (except FL grade 3B), MCL and marginal zone lymphoma (MZL)\n3. Have measurable nodal disease\n4. Are willing to undergo lymph node biopsies or biopsies of other involved tissue\n5. Have relapsed disease or disease refractory to conventional treatment or for which no standard therapy exists\n6. Have received at least one line of conventional previous therapy which must include at least one rituximab-based regimen\n7. Have a life expectancy of at least 12 weeks\n8. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2\n9. Have CD20+ malignancy\n10. Have hematological and biochemical indices within prespecified ranges\n\nExclusion Criteria:\n\n1. Have had an allogenic bone marrow or stem cell transplant within 12 months\n2. Have presence of active chronic graft versus host disease\n3. Have current leptomeningeal lymphoma or compromise of the central nervous system\n4. Have transformed lymphoma from a pre-existing indolent lymphoma\n5. Have Waldenstrom's Macroglobulinemia or FL grade 3B,\n6. Need systemic doses of prednisolone \\>10 mg daily (or equipotent doses of other corticosteroids) while on the study trial other than as pre-medication.\n7. Have known or suspected hypersensitivity to rituximab or BI-1206\n8. Have cardiac or renal amyloid light-chain amyloidosis\n9. Have received any of the following:\n\n   1. Chemotherapy or small molecule products with 2 weeks of first dose of BI-1206\n   2. Radiotherapy (except for focal symptomatic control of lymphadenopathy) within 4 weeks\n   3. Immunotherapy within 8 weeks\n   4. Previous lines of treatment containing BTK inhibitors for Subjects receiving BI-1206 in combination with rituximab and acalabrutinib\n10. Have ongoing toxic manifestations of previous treatments.\n11. Have the ability to become pregnant (or already pregnant or lactating\u002Fbreastfeeding).\n12. Have had major surgery from which the subject has not yet recovered.\n13. Are at high medical risk because of non-malignant systemic disease including active infection on treatment with antibiotics, antifungals or antivirals.\n14. Are serologically positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV).\n15. Have an active, known or suspected autoimmune disease.\n16. Have concurrent congestive heart failure, prior history of class III\u002F IV cardiac disease (New York Heart Association \\[NYHA\\])\n17. Have current malignancies of other types",[85,86],"ADULT","OLDER_ADULT",[88,98,110,125,138,150,162,174,182,191,199,207,215,228,235,244,250,263,273,281,289,300,309,317,328,340,348],{"facility":89,"status":90,"city":91,"state":92,"zip":93,"country":94,"geoPoint":95},"Emory University Hospital","ACTIVE_NOT_RECRUITING","Atlanta","Georgia","30322","United States",{"lat":96,"lon":97},33.749,-84.38798,{"facility":99,"status":8,"city":100,"state":101,"zip":102,"country":94,"contacts":103,"geoPoint":107},"Norton Cancer Institute - St. Matthews 3991 Dutchmans Lane Medical Plaza II, Suite 405","Louisville","Kentucky","40207",[104],{"name":105,"role":106},"Don Stevens, MD","PRINCIPAL_INVESTIGATOR",{"lat":108,"lon":109},38.25424,-85.75941,{"facility":111,"status":8,"city":112,"state":113,"country":114,"contacts":115,"geoPoint":122},"Hospital São Rafael","Salvador","Estado de Bahia","Brazil",[116,120],{"name":117,"role":118,"email":119},"Cacilda","CONTACT","analuziaschriefer@gmail.com",{"name":121,"role":106},"Ana Luiza Schriefer, MD",{"lat":123,"lon":124},-12.97563,-38.49096,{"facility":126,"status":8,"city":127,"state":128,"country":114,"contacts":129,"geoPoint":135},"Hospital de Clínicas de Porto Alegre","Porto Alegre","Rio Grande do Sul",[130,133],{"name":131,"role":118,"email":132},"Suellen","fogliattopesquisa@gmail.com",{"name":134,"role":106},"Laura Maria Fogliatto, MD",{"lat":136,"lon":137},-30.03283,-51.23019,{"facility":139,"status":140,"city":141,"country":114,"contacts":142,"geoPoint":147},"Hospital Erasto Gaertner - Liga Paranaense de Combate ao Câncer","NOT_YET_RECRUITING","Curitiba",[143,145],{"role":118,"email":144},"munhoz.ec@gmail.com",{"name":146,"role":106},"Eduardo Munhoz, MD",{"lat":148,"lon":149},-25.42778,-49.27306,{"facility":151,"status":140,"city":152,"country":114,"contacts":153,"geoPoint":159},"Ruschel Medicina e Pesquisa Clínica","Rio de Janeiro",[154,157],{"name":155,"role":118,"email":156},"Thaiane Alexandre, RN","thaianealexandre@ruschelmedicina.com.br",{"name":158,"role":106},"Rony Schaffel, MD",{"lat":160,"lon":161},-22.90642,-43.18223,{"facility":163,"status":8,"city":164,"country":114,"contacts":165,"geoPoint":171},"A.C. Camargo Cancer Center","São Paulo",[166,169],{"name":167,"role":118,"email":168},"RN","ana.cordeiro@accamargo.org.br",{"name":170,"role":106},"Ana Costa Cordeiro, MD",{"lat":172,"lon":173},-23.5475,-46.63611,{"facility":175,"status":140,"city":164,"country":114,"contacts":176,"geoPoint":181},"Hospital Amaral Carvalho",[177,179],{"role":118,"email":178},"pesquisafac.edersonmattos@gmail.com",{"name":180,"role":106},"Ederson Roberto De Mattos, MD",{"lat":172,"lon":173},{"facility":183,"status":140,"city":164,"country":114,"contacts":184,"geoPoint":190},"Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo",[185,188],{"name":186,"role":118,"email":187},"Camila Hinsching, RN","camila.f@hc.fm.usp.br",{"name":189,"role":106},"Juliana Pereira, MD",{"lat":172,"lon":173},{"facility":192,"status":8,"city":164,"country":114,"contacts":193,"geoPoint":198},"Hospital Israelita Albert Einstein",[194,196],{"name":167,"role":118,"email":195},"guiperini@gmail.com",{"name":197,"role":106},"Guilherme Perini, MD",{"lat":172,"lon":173},{"facility":200,"status":140,"city":164,"country":114,"contacts":201,"geoPoint":206},"Hospital Samaritano",[202,204],{"role":118,"email":203},"carlos.chiattone@terra.com.br",{"name":205,"role":106},"Carlos Chiattone, MD",{"lat":172,"lon":173},{"facility":208,"status":140,"city":164,"country":114,"contacts":209,"geoPoint":214},"Hospital Sírio-Libanês",[210,212],{"role":118,"email":211},"anaritafonsecabm@gmail.com",{"name":213,"role":106},"Ana Rita Da Fonseca, MD",{"lat":172,"lon":173},{"facility":216,"status":140,"city":217,"state":218,"country":219,"contacts":220,"geoPoint":225},"Krankenhaus Nordwest Klinik für Onkologie und Hämatologie","Frankfurt am Main","Hesse","Germany",[221,223],{"role":118,"email":222},"weidmann.eckhart@khnw.de",{"name":224,"role":106},"Eckhart Weidmann, MD",{"lat":226,"lon":227},50.11552,8.68417,{"facility":229,"status":230,"city":231,"country":219,"geoPoint":232},"Robert Bosch Hospital, Dep of Hematology, Oncology and Palliative care","WITHDRAWN","Stuttgart",{"lat":233,"lon":234},48.78232,9.17702,{"facility":236,"status":237,"city":238,"zip":239,"country":240,"geoPoint":241},"Szpital Specjlistyczny","TERMINATED","Grudziądz","86-300","Poland",{"lat":242,"lon":243},53.48411,18.75366,{"facility":245,"status":237,"city":246,"country":240,"geoPoint":247},"Małopolskie Centrum Medyczne","Krakow",{"lat":248,"lon":249},50.06143,19.93658,{"facility":251,"status":8,"city":252,"state":253,"country":254,"contacts":255,"geoPoint":260},"Hospital ICO, Trias i Pujol","Badalona","Barcelona","Spain",[256,258],{"role":118,"email":257},"jsancho@iconcologia.net",{"name":259,"role":106},"Juan Manuel Sancho Cia, MA",{"lat":261,"lon":262},41.45004,2.24741,{"facility":264,"status":8,"city":253,"country":254,"contacts":265,"geoPoint":270},"Hospital de la Santa Creu i Sant Pau, Dep Hematologia",[266,268],{"role":118,"email":267},"smiqueleiz@santpau.cat",{"name":269,"role":106},"Sara Miqueleiz Alamos, MD",{"lat":271,"lon":272},41.38879,2.15899,{"facility":274,"status":8,"city":253,"country":254,"contacts":275,"geoPoint":280},"Hospital Universitari Vall d'Hebron",[276,278],{"role":118,"email":277},"pabrisqueta@vhio.net",{"name":279,"role":106},"Pablo Abrisqueta Costa, MD",{"lat":271,"lon":272},{"facility":282,"status":8,"city":253,"country":254,"contacts":283,"geoPoint":288},"Institut Català d'Oncologia, L'Hospitalet de Llobregat",[284,286],{"role":118,"email":285},"edomingo@iconcologia.net",{"name":287,"role":106},"Eva Domingo Domenech, MD",{"lat":271,"lon":272},{"facility":290,"status":8,"city":291,"country":254,"contacts":292,"geoPoint":297},"Hospital General Universitario Gregorio Marañon-Oncología Médica","Madrid",[293,295],{"role":118,"email":294},"bastosmariana@yahoo.com",{"name":296,"role":106},"Mariana Bastos Oreiro, MD",{"lat":298,"lon":299},40.4165,-3.70256,{"facility":301,"status":8,"city":291,"country":254,"contacts":302,"geoPoint":308},"Hospital Universitario HM Sanchinarro",[303,306],{"name":304,"role":118,"email":305},"Agustín Penedo Coello","apenedo@hmhospitales.com",{"name":307,"role":106},"Augustin Penedo Coello, MD",{"lat":298,"lon":299},{"facility":310,"status":8,"city":291,"country":254,"contacts":311,"geoPoint":316},"University Hospital Fundacion Jimenez Diaz",[312,314],{"role":118,"email":313},"raul.cordoba@fjd.es",{"name":315,"role":106},"Raul Cordoba Mascunano, MD",{"lat":298,"lon":299},{"facility":318,"status":140,"city":319,"country":254,"contacts":320,"geoPoint":325},"Hospital Universitario Virgen de la Arrixaca","Murcia",[321,323],{"role":118,"email":322},"joaquingomezespuch@hotmail.com",{"name":324,"role":106},"Joaquin Gomez Espuch, MD",{"lat":326,"lon":327},37.98704,-1.13004,{"facility":329,"status":8,"city":330,"country":254,"contacts":331,"geoPoint":337},"Hospital University Virgen Macarene","Seville",[332,335],{"name":333,"role":118,"email":334},"Sergio Ortegón Alcaide","sortegonalcaide@gmail.com",{"name":336,"role":106},"Sergio Ortegon Alcaide, MD",{"lat":338,"lon":339},37.38283,-5.97317,{"facility":341,"status":237,"city":342,"zip":343,"country":344,"geoPoint":345},"Department of Oncology, Skåne University Hospital","Lund","SE-22185","Sweden",{"lat":346,"lon":347},55.70584,13.19321,{"facility":349,"status":237,"city":350,"zip":351,"country":344,"geoPoint":352},"Department of Oncology, Academical Hospital","Uppsala","751 85",{"lat":353,"lon":354},59.85882,17.63889,[356,360],{"name":357,"role":118,"phone":358,"email":359},"Erika Bågeman","+46706126618","erika.bageman@bioinvent.com",{"name":361,"role":118,"email":362},"Andres McAllister, MD, PhD","andres.mcallister@bioinvent.com",[],[],[],{"nct_id":4,"conditions":367,"biomarkers":371},[368,19,369,370],"Follicular Lymphoma","Mantle Cell Lymphoma","Marginal Zone Lymphoma",[372],"MS4A1 Gene",{"nct_id":4,"found":374,"summary":375,"prompt_version":385},true,{"design":376,"status":377,"heading":378,"summary":379,"follow_up":380,"word_count":381,"commitments":382,"compensation":383,"drugs_mentioned":384},"This is a Phase 1\u002F2a, multi-center, open-label study involving dose escalation and expansion, with approximately 140 participants.","completed","Study of BI-1206 for Indolent B-Cell Non-Hodgkin Lymphoma","This study is testing a new treatment called BI-1206 in combination with rituximab, and sometimes also with acalabrutinib, for people with indolent B-cell Non-Hodgkin Lymphoma (a type of slow-growing blood cancer) that has returned or didn't respond to previous rituximab treatment. The study aims to find the safest and most effective dose of BI-1206 when given with these other medications. You might be able to join if you are 18 or older, have specific types of B-cell NHL (follicular lymphoma, marginal zone lymphoma, or mantle cell lymphoma), and have measurable disease. The study is currently recruiting about 140 participants.","Safety and dose-limiting toxicities are measured during the 28-day treatment period on induction therapy.",99,"You would undergo lymph node biopsies or biopsies of other involved tissue. The study involves a 28-day treatment period on induction therapy.","Not stated in the trial record.",[32,41,47],"v2"]