RecruitingPhase 1Phase 2NCT04669171

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


Sponsor

Enterome

Enrollment

80 participants

Start Date

Jul 5, 2021

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new cancer vaccine called EO2463, alone or combined with other treatments, for patients with slow-growing (indolent) non-Hodgkin lymphoma — including follicular lymphoma (FL) and marginal zone lymphoma (MZL). The vaccine is designed to train the immune system to attack lymphoma cells. **You may be eligible if you:** - Have been diagnosed with grade 1, 2, or 3A follicular lymphoma or marginal zone lymphoma - Are in good enough health to participate (ECOG performance status 0–2) - Have either relapsed/refractory disease after at least one prior treatment, OR are newly diagnosed with low tumor burden and not currently needing standard treatment **You may NOT be eligible if you:** - Have high-grade (aggressive) lymphoma - Have already received multiple lines of intensive therapy that have left your organs significantly impaired - Have other conditions that make you ineligible per study criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALEO2463

Multiple dose of EO2463

DRUGlenalidomide

D1-21 of 4-weekly cycles

BIOLOGICALrituximab

Multiple doses of rituximab


Locations(12)

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

University of Rochester Medical Center (URMC) - Wilmot Cancer Institute (WCI) (James P. Wilmot Cancer Center)

Rochester, New York, United States

University of Washington-Seattle Cancer Care Alliance

Seattle, Washington, United States

CHU d'Amiens-Picardie - Hopital SUD

Amiens, France

University of Bologna

Bologna, Italy

IRCCS Policlinico San Matteo Foundation - University of Pavia

Naples, Italy

IRCCS Policlinico San Matteo Foundation - University of Pavia

Pavia, Italy

University Hospital Vall d'Hebron, Institute of Oncology

Barcelona, Spain

Clinica Universidad de Navarra

Madrid, Spain

Clinica Universidad de Navarra

Pamplona, Spain

Hospital Clinico Universitario de Salamanca

Salamanca, Spain

View Full Details on ClinicalTrials.gov

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NCT04669171


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