Odronextamab (Ordspono) as monotherapy for the treatment of relapsed or refractory follicular lymphoma (r/r FL) or diffuse large B?cell lymphoma (r/r DLBCL) Odronextamab (Ordspono®) as monotherapy for the treatment of relapsed or refractory follicular lymphoma (r/r FL) or diffuse large B‑cell lymphoma (r/r DLBCL) - Repository of AIHTA GmbH English | Deutsch Atom RSS 1.0 RSS 2.0 * Simple search * Advanced search * Help * Services * Login * Browse * Type * Subject * Author / Editor * Institution * Year AIHTA - Publications - Search - Odronextamab (Ordspono®) as monotherapy for the treatment of relapsed or refractory follicular lymphoma (r/r FL) or diffuse large B‑cell lymphoma (r/r DLBCL) Rothschedl, E. and Grössmann, N.(2024):Odronextamab (Ordspono®) as monotherapy for the treatment of relapsed
Odronextamab monotherapy in R/R DLBCL after progression with CAR T-cell therapy: Primary analysis of the ELM-1 study. Patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) progressing after chimeric antigen receptor T-cell therapy (CAR T) have dismal outcomes. The prespecified post-CAR T expansion cohort of the ELM-1 study investigated the efficacy and safety of odronextamab, a CD20×CD3 bispecific antibody, in patients with disease progression after CAR T. Sixty patients received IV odronextamab weekly for 4 cycles followed by maintenance until progression. The primary endpoint was objective response rate (ORR) by independent central review. The median number of prior lines of therapy was 3 (range 2-9), 71.7% were refractory to CAR T, and 48.3% relapsed within 90
Odronextamab, a human CD20×CD3 bispecific antibody in patients with CD20-positive B-cell malignancies (ELM-1): results from the relapsed or refractory non-Hodgkin lymphoma cohort in a single-arm, multicentre, phase 1 trial. Odronextamab is a hinge-stabilised, fully human IgG4-based CD20 × CD3 bispecific antibody that binds CD3 on T cells and CD20 on B cells. We aimed to evaluate the safety and antitumour activity of odronextamab in patients with relapsed or refractory B-cell non-Hodgkin lymphoma. This single-arm, multicentre, phase 1, dose-escalation and dose-expansion (ELM-1) trial was conducted at ten academic sites across the USA and Germany. Patients aged 18 years or older with CD20-positive relapsed or refractory B-cell malignancies who previously received CD20-directed antibody therapy
Zanubrutinib in Combination With Odronextamab for the Treatment of Patients With Richter's Transformation This phase I trial tests the safety and side effects of zanubrutinib in combination with odronextamab and how well it works in treating patients with Richter's transformation. Zanubrutinib, a tyrosine kinase inhibitor, blocks a protein called Bruton tyrosine kinase (BTK), which may help keep cancer cells from growing. Odronextamab is a bispecific monoclonal antibody that can bind to two different antigens at the same time. Odronextamab binds to CD20 found on B-cells (a type of white blood cell) and on many B-cell cancers and to CD3 on T-cells (also a type of white blood cell) and may interfere with the ability of cancer cells to grow and spread. Giving zanubrutinib in combination
Odronextamab for the Treatment of Relapsed and Refractory Diffuse Large B-cell Lymphoma Before and After Chimeric Antigen Receptor T-cell Therapy This phase II trial tests how well odronextamab works before and after standard of care (SOC) chimeric antigen receptor (CAR) T-cell therapy in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Odronextamab is a monoclonal antibody that is called bispecific, as it individually targets 2 cell proteins, CD20 and CD3
Odronextamab for Relapsed and Refractory Large B-cell Lymphomas Before CAR-T This phase II trial tests the effectiveness of odronextamab given before chimeric antigen receptor T (CAR-T) cell therapy (bridging therapy) in patients with large B-cell lymphomas that have come back after a period of improvement (relapsed) or that have not responded to previous treatment (refractory). Odronextamab is a bispecific antibody that can bind to two different antigens at the same time. Odronextamab binds to CD3, a T-cell surface antigen, and CD20 (a tumor-associated antigen that is expressed on B-cells during most stages of B-cell development and is often overexpressed in B-cell cancers) and may interfere with the ability of cancer cells to grow and spread. Bridging therapy has been used to maintain disease
A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma The study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on patients with previously treated aggressive B-cell non-Hodgkin lymphoma whose cancer has stopped responding
A Trial to Learn if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Participants With Follicular Lymphoma and Marginal Zone Lymphoma This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on patients who have one of two types of cancer: follicular lymphoma (FL) or marginal with lenalidomide, in participants with FL or MZL, and to determine the dose of the study drug to be used in Part 2 of this study. This combination is considered "first-in-human" as it has not been tested as a combination treatment in humans before. The aim of Part 2, of the study is to assess how the combination of odronextamab and lenalidomide works compared to the combination of rituximab and lenalidomide
A Study to Learn How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Compared to Rituximab and Chemotherapy in Adult Participants With Previously Untreated Follicular Lymphoma This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma in Part 2, as well
A Trial to Learn if Odronextamab is Safe and Well-tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Participants With Follicular Lymphoma This study is researching an experimental drug called odronextamab, referred to as study drug. The study is focused on participants with previously untreated follicular lymphoma (a type of non-Hodgkin
A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Patients With Previously Untreated Diffuse Large B-cell Lymphoma This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with diffuse large B
Study to Assess the Safety and Tolerability of REGN5837 in Combination With Odronextamab in Patients With Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma The primary objective of the study is:To assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine recommended phase 2 dose (RP2D) regimen(s) (defined as either a maximum tolerated dose (MTD) regimen or a lower dose regimen) of REGN5837 in combination with odronextamab in patients with relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (B-NHL)The secondary objectives of the study are:To evaluate the pharmacokinetics (PK) of REGN5837 when given in combination with odronextamabTo evaluate the PK of odronextamab when given in combination with REGN5837To assess the immunogenicity of REGN5837
Assess the Anti-Tumor Activity and Safety of Odronextamab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma Primary objective is to assess the anti-tumor activity of single agent odronextamab as measured by the objective response rate (ORR) according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review , or patients who have demonstrated intolerance to BTK inhibitor therapy, and who have progressed after other systemic therapy.In patients with marginal zone lymphoma (MZL) *1In patients with other B-NHL subtypes *1Secondary objectives are:To assess the anti-tumor activity of single agent odronextamab in each of 5 disease-specific cohorts, as measured by:ORR according to the Lugano Classification
- Epcoritamab- Mosunetuzumab- Teclistamab- Talquetamab- Odronextamab- Elranatamab- ABBV-383Comparator(s)/controlSubgroup analysis between entities, productsMain outcome(s)Non-relapse mortality (NRM) and number and causes of deathMeasures of effectNRM as cumulative incidence, death events as numberAdditional outcome(s)Follow-Up time and size of study populationMeasures of effectFollow-Up time in months, study
A Phase 1 Study to Investigate the Safety and Tolerability of REGN1979 in Patients With CD20+ B-Cell Malignancies Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies - Full Text View - ClinicalTrials.gov Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort. Hide glossary GlossaryStudy record managers Save this study WarningYou have reached the maximum number of saved studies (100).Please remove one or more studies before adding more. Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies (ELM-1) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has