Assess the Anti-Tumor Activity and Safety of Odronextamab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

• Status: Recruiting
• Trial end date: 2028-12-15

Summary

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 in each of the following B-cell non-Hodgkin lymphoma (B-NHL) subgroups:

• In patients with follicular lymphoma (FL) grade 1-3a *1,2

• In patients with diffuse large B-cell lymphoma (DLBCL) *1,2

• In patients with mantle cell lymphoma (MCL) that has relapsed after or is refractory to a BTK inhibitor. This cohort will also include patients who have relapsed or have disease refractory to prior systemic therapy, 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) *1

• In patients with other B-NHL subtypes *1

Secondary 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 and as assessed by local investigator evaluation

• Complete response (CR) rate according to the Lugano Classification and as assessed local by local investigator evaluation and independent central review

• Progression-free survival (PFS)*3

• Overall survival (OS)

• Duration of response (DOR)*3

• Disease control rate (DCR)*3

• To evaluate the safety and tolerability of odronextamab

• To assess the pharmacokinetics (PK) of odronextamab

• To assess the immunogenicity of odronextamab

• To assess the effect of odronextamab on patient reported outcomes, including health-related quality of life (HRQL), as measured by the validated instruments European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym), and EuroQoL 5 Dimensions 3 Levels (EQ-5D-3L)

• 1 that has relapsed after or is refractory to at least 2 prior lines of systemic therapy

• 2 including an anti-CD20 antibody and an alkylating agent

• 3 according to Lugano Classification and as assessed by independent central review and local investigator evaluation

• Phase: Phase 2

Details

• Lead Sponsor: Regeneron Pharmaceuticals