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RECRUITINGPHASE1/PHASE2

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

NCT04669171•Enterome

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. For inclusion in Cohorts 1 and 4 patients should have relapsed/refractory, biopsy-proven grade 1, 2 or 3A, FL or MZL, ECOG performance status 0 to 2, and have received at least one prior line of treatment. For inclusion in Cohort 4b the above applies except that patients with FL, and not patients with MZL, will be eligible for enrollment.
•2. For inclusion in Cohort 2 patients should have newly diagnosed, previously untreated (radiotherapy as only prior treatment is allowed), biopsy-proven grade 1, 2 or 3A, FL or MZL. ECOG performance status 0 or 1, low tumor burden by Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria, and not be in need of standard of care therapy according to the assessment of the treating physician.
•3. For inclusion in Cohort 3 patients should have newly diagnosed, previously untreated (radiotherapy as only prior treatment is allowed), biopsy-proven grade 1, 2 or 3A, FL or MZL. ECOG performance status 0 or 1, low tumor burden by GELF criteria and be in need of therapy according to the assessment of the treating physician.
•4. Patients with an age ≥ 18 years old.
•5. Patients who are human leukocyte antigen (HLA)-A2 positive.
•6. Patients should have radiologically measurable disease with a lymph node or tumor mass greater than or equal to 1.5 cm in at least one dimension.
•7. Males or non-pregnant, non-lactating, females.
•8. Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.
•9. Patients having received the information sheet and who have provided written informed consent prior to any study-related procedures.

Exclusion Criteria

•1. Patients treated with dexamethasone \> 2 mg/day or equivalent (i.e. 13 mg/day of prednisone, or 53 mg/day of hydrocortisone) within 14 days before the first EO2463 administration, unless required to treat an adverse event.
•2. Patients with grade 3B FL or transformation to an aggressive lymphoma subtype.
•3. Patients with only one prior treatment and a high-risk profile as defined by first progression of disease within 24 months of diagnosis (the exclusion is not applicable for patients with more than one prior line treatment).
•4. Patients with prior exposure to EO2463.
•6. Patients to be included in Cohorts 1 and 4, and who have received rituximab or other B cell ablation therapy within 8 weeks of start of study treatment.
•7. Patients to be included in Cohorts 4, who received prior CAR T-cell therapy and progressed within 6 months after this therapy.
•8. Patients with abnormal laboratory values.
•9. Patients with persistent Grade 3 or 4 toxicities.
•10. Uncontrolled central nervous system (CNS) metastasis.
•11. Other malignancy or prior malignancy with a disease-free interval of less than 3 years.
+5 more criteria

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

Key Dates

Start Date

July 5, 2021

Primary Completion Date

May 30, 2029

Completion Date

May 30, 2034

Last Updated

January 30, 2026

Enrollment

ESTIMATED participants

Conditions

Follicular LymphomaMarginal Zone Lymphoma

Interventions

EO2463

BIOLOGICAL

lenalidomide

DRUG

rituximab

BIOLOGICAL

Contacts

Jan Fagerberg, MD, PhD

CONTACT

+32 3 205 55 55 medicalmonitoring-hem@enterome.com

Karlijn Kroon, MD

CONTACT

+33 611300589 kkroon-ext@enterome.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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