Phase 12 Global Study of EO2463 Vaccine Alone and With Lenalidomide and Rituximab for Treating Indolent Non-Hodgkins Lymphoma

What this Trial Is About

Researchers are evaluating EO2463, a new therapeutic vaccine made from peptides related to tumor and microbiome proteins, in patients with indolent non-Hodgkin lymphoma NHL. The study aims to find the best dose for Phase 2, assess safety, tolerability, immune response, and early signs of how well the vaccine works alone and combined with lenalidomide and rituximab. This research focuses on patients with follicular lymphoma or marginal zone lymphoma. The study includes several groups one with EO2463 alone for 6 weeks followed by adding lenalidomide and possibly rituximab based on response groups with newly diagnosed patients receiving EO2463 alone or with rituximab and groups with previously treated patients receiving EO2463 combined with lenalidomide and rituximab. Treatments are given in cycles, with doses and combinations adjusted according to patient response and safety findings. Participants will undergo monitoring for up to 24 months to evaluate adverse events, overall and complete response rates, and immune responses related to EO2463 components. Survival will also be tracked for up to 7 years after enrollment. Throughout the study, patients will have scheduled visits, lab tests, and assessments to track safety, immune reactions, and treatment effects, ensuring detailed follow-up and data collection.

A Novel Vaccine (EO2463) as Monotherapy and in Combination, for Treatment of Patients With Indolent Non-Hodgkin Lymphoma