NCT04669171

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

A Global Multicenter Phase 1/2 Trial of EO2463, a Novel Microbial-Derived Peptide Therapeutic Vaccine, as Monotherapy, and in Combination With Lenalidomide and Rituximab, for Treatment of Patients With Indolent Non-Hodgkin's Lymphoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Enterome · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to define the recommended Phase 2 Dose, safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 during monotherapy and in combination with lenalidomide and/or rituximab in patients with indolent NHL

Detailed description

EO2463 Is an innovative cancer peptide therapeutic vaccine based on the homologies between tumor associated antigens and microbiome-derived peptides that will be administered alone and in combination with lenalidomide, rituximab, and lenalidomide/rituximab to generate safety and preliminary efficacy data in patients with indolent NHL

Conditions

• Follicular Lymphoma
• Marginal Zone Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	EO2463	Multiple dose of EO2463
DRUG	lenalidomide	D1-21 of 4-weekly cycles
BIOLOGICAL	rituximab	Multiple doses of rituximab

Timeline

• Start date: 2021-07-05
• Primary completion: 2029-05-30
• Completion: 2034-05-30
• First posted: 2020-12-16
• Last updated: 2026-01-30

Locations

12 sites across 4 countries: United States, France, Italy, Spain

Regulatory

• FDA-regulated drug study