Krankenhaus Nordwest Klinik für Onkologie und Hämatologie Frankfurt (Hessen) GermanyNoch nicht rekrutierend» Google-MapsRobert Bosch Hospital, Dep of Hematology, Oncology and Palliative care Stuttgart (Baden-Württemberg) GermanyNoch nicht rekrutierend» Google-Maps Ansprechpartner: RN» Ansprechpartner anzeigenEmory University Hospital 30322 Atlanta United StatesRekrutierend» Google-Maps Ansprechpartner: Jonathon Cohen, MD» Ansprechpartner anzeigen
Norton Cancer Institute - St. Matthews 3991 Dutchmans Lane Medical Plaza II, Suite 405 40207 Louisville United StatesRekrutierend» Google-MapsHospital São Rafael Salvador BrazilNoch nicht rekrutierend» Google-Maps Ansprechpartner: Cacilda» Ansprechpartner anzeigenHospital de Clínicas de Porto Alegre Porto Alegre BrazilNoch nicht rekrutierend» Google-Maps Ansprechpartner: Suellen» Ansprechpartner anzeigenA.C. Camargo Cancer Center São Paulo BrazilNoch nicht rekrutierend» Google-Maps Ansprechpartner: RN» Ansprechpartner anzeigenHospital Israelita Albert Einstein São Paulo BrazilNoch nicht rekrutierend» Google-Maps Ansprechpartner: RN» Ansprechpartner anzeigenHospital Sírio-Libanês São Paulo BrazilNoch nicht rekrutierend» Google-MapsSzpital Specjlistyczny 86-300 Grudziadz PolandAbgebrochen» Google-MapsMałopolskie Centrum Medyczne Krakow PolandAbgebrochen» Google-MapsHospital ICO, Trias i Pujol Badalona SpainRekrutierend» Google-MapsHospital de la Santa Creu i Sant Pau, Dep Hematologia Barcelona SpainRekrutierend» Google-MapsHospital Universitari Vall d'Hebron Barcelona SpainRekrutierend» Google-MapsInstitut Català d'Oncologia, L'Hospitalet de Llobregat Barcelona SpainRekrutierend» Google-MapsHospital General Universitario Gregorio Marañon-Oncología Médica Madrid SpainRekrutierend» Google-MapsHospital Universitario HM San Chinarro Madrid SpainNoch nicht rekrutierend» Google-MapsUniversity Hospital Fundacion Jimenez Diaz Madrid SpainRekrutierend» Google-MapsHospital Universitario Virgen de la Arrixaca Murcia SpainNoch nicht rekrutierend» Google-MapsHospital Virgen Macarene Seville SpainNoch nicht rekrutierend» Google-MapsDepartment of Oncology, Skåne University Hospital SE-22185 Lund SwedenRekrutierend» Google-Maps Ansprechpartner: Mats Jerkeman, PI» Ansprechpartner anzeigenDepartment of Oncology, Academical Hospital 751 85 Uppsala SwedenAbgebrochen» Google-Maps
1. Documenting AEs and SAEs and determining causality in relation to BI-1206 and/or rituximab (Time Frame - During the 28-day treatment period on induction therapy): Assess the safety and tolerability profile of BI-1206 when administered intravenously (IV) or subcutaneously (SC) in combination with rituximab in subjects with relapsed or refractory B-cell non-Hodgkin lymphoma (NHL),subtypes follicular lymphoma (FL)(except FLgrade 3B), marginal zone lymphoma (MZL), and mantle cell lymphoma (MCL).
2. 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) (Time Frame - During the 28-day treatment period on induction therapy): Select 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.
Secondary outcome:
1. Evaluation of PK parameters for BI-1206. (Time Frame - Up to 1 year): Study the PK profile of BI-1206 when administered IV or SC in combination with rituximab in subjects with relapsed or refractory B-cell NHL, subtypes FL (except FL grade 3B), MZL and MCL.
2. Evaluation of PK parameters for rituximab during the BI-1206 treatment period. (Time Frame - Up to 1 year): Study the PK profile of rituximab when administered in combination with BI-1206 (IV or SC).
3. Evaluation of ADA response to BI 1206. (Time Frame - Up to 1 year): Assess the immunogenicity of BI-1206 when administered IV or SC in combination with rituximab.
4. Measurement of B cell depletion. (Time Frame - Up to 1 year): Evaluate the effect of BI-1206 administered IV or SC in combination with rituximab on the depletion of B-cells.
5. Assessment of overall response rate (ORR) according to the response criteria for malignant lymphoma (Cheson, 2014). (Time Frame - Up to 1 year): Assess possible anti-tumor activity of BI-1206 administered IV or SC in combination with rituximab at Week 6 after first dose of BI-1206 and for subjects who continue during maintenance therapy.
6. CD32b protein expression levels (Time Frame - Up to 1 year): Investigate CD32b protein expression levels; evaluate any potential correlation with clinical responses.