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

NCT04669171 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: EONHL1-20
• Study Type: interventional
• Target: 80
• Locations: 4 countries
• Sites: 12

Brief 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

Conditions

Follicular Lymphoma; Marginal Zone Lymphoma

Keywords

Follicular Lymphoma; Marginal Zone Lymphoma; Rituximab; Lenalidomide; Peptide-based immunotherapy

Outcome Measures

Primary Outcomes (3)

• Phase 1: Recommended Phase 2 Dose | Adverse Events Assessment |

  Incidences of adverse events, Treatment-Emergent Adverse events, Serious Adverse Events, Deaths, and Laboratory Abnormalities Using the National Cancer Institute-Common Terminology Criteria for Adverse events (NCI-CTCAE) V5.0.

  Up to 24 months

• Phase 2: Overall Response Rate

  Overall Response Rate According to the Lugano Classification 2014 during EO2463 Monotherapy

  Up to 24 months

• Phase 2: Complete Response Rate

  Complete remission (CR)-rate according to the Lugano Classification 2014 during therapy with the combination of EO2463/lenalidomide/rituximab.

  Up to 24 months

Secondary Outcomes (2)

• Assessment of the Immunogenicity in Relation to OMP72, OMP64, OMP65, OMP66, and UCP2 that Compose EO2463

  Up to 24 months

• Evaluation of Overall Survival

  Up to 7 years after last patient enrolled

Study Arms (4)

Cohort 1

EXPERIMENTAL

Safety Lead-In, Dose-Finding, Cohort, with a 3-by-3 design of EO2463 monotherapy for 6 weeks followed by addition of lenalidomide. Then, if applicable rituximab (depending on response with EO2463 + lenalidomide) will be added. Four to 18 previously treated patients with Follicular Lymphoma (FL) or Marginal Zone Lymphoma (MZL) were anticipated to be included based on safety findings.

Biological: EO2463; Drug: lenalidomide; Biological: rituximab

Cohort 2

EXPERIMENTAL

Anticipated approximatively 25 previously untreated patients with FL or MZL with an evaluation of EO2463 monotherapy (at the established dose in Cohort 1).

Biological: EO2463

Cohort 3

EXPERIMENTAL

Anticipated approximatively 6 previously untreated patients with FL or MZL with an evaluation of EO2463 (at the established dose in cohort 1) as monotherapy for 6 weeks followed by addition of rituximab if applicable (depending on response with EO2463 monotherapy).

Biological: EO2463; Biological: rituximab

Cohort 4

EXPERIMENTAL

Anticipated approximatively 40 patients previously treated patients with FL (or MZL). Evaluation of EO2463 (at the established dose in Cohort 1) in combination with lenalidomide from day 1 and then with addition of rituximab.

Biological: EO2463; Drug: lenalidomide; Biological: rituximab

Interventions

EO2463 BIOLOGICAL

Multiple dose of EO2463

Cohort 1; Cohort 2; Cohort 3; Cohort 4

lenalidomide DRUG

D1-21 of 4-weekly cycles

Also known as: Revlimid

Cohort 1; Cohort 4

rituximab BIOLOGICAL

Multiple doses of rituximab

Also known as: MabThera

Cohort 1; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with an age ≥ 18 years old.
• Patients who are human leukocyte antigen (HLA)-A2 positive.
• 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.
• Males or non-pregnant, non-lactating, females.
• Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests, and other study procedures indicated in the protocol.
• Patients having received the information sheet and who have provided written informed consent prior to any study-related procedures.

You may not qualify if:

• 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.
• Patients with grade 3B FL or transformation to an aggressive lymphoma subtype.
• Patients with prior exposure to EO2463.
• 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.
• Patients to be included in Cohorts 4, who received prior CAR T-cell therapy and progressed within 6 months after this therapy.
• Patients with abnormal laboratory values.
• Patients with persistent Grade 3 or 4 toxicities.
• Uncontrolled central nervous system (CNS) metastasis.
• Other malignancy or prior malignancy with a disease-free interval of less than 3 years.
• Patients with clinically significant disease.
• Patients with suspected autoimmune or active autoimmune disorder or known history of an autoimmune neurologic condition (e.g. Guillain-Barré syndrome).
• Patients with history of solid organ transplantation or allogeneic hematopoietic stem cell transplantation.
• Pregnant and breastfeeding patients.
• Patients with history or presence of human immunodeficiency virus and/or potentially active hepatitis B virus/hepatitis C virus infection.

Sponsors & Collaborators

• Enterome: lead

Study Sites (12)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

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

Rochester, New York, 14642, United States

RECRUITING

University of Washington-Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

RECRUITING

CHU d'Amiens-Picardie - Hopital SUD

Amiens, France

RECRUITING

University of Bologna

Bologna, Italy

WITHDRAWN

IRCCS Policlinico San Matteo Foundation - University of Pavia

Naples, Italy

RECRUITING

IRCCS Policlinico San Matteo Foundation - University of Pavia

Pavia, Italy

RECRUITING

University Hospital Vall d'Hebron, Institute of Oncology

Barcelona, Spain

RECRUITING

Clinica Universidad de Navarra

Madrid, Spain

RECRUITING

Clinica Universidad de Navarra

Pamplona, Spain

RECRUITING

Hospital Clinico Universitario de Salamanca

Salamanca, Spain

RECRUITING

MeSH Terms

Conditions

Lymphoma, Follicular; Lymphoma, B-Cell, Marginal Zone

Interventions

Lenalidomide; Rituximab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma, B-Cell

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Jan Fagerberg, MD

  Enterome

  STUDY DIRECTOR

Central Study 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 16, 2020
• Study Start: July 5, 2021
• Primary Completion (Estimated): May 30, 2029
• Study Completion (Estimated): May 30, 2034
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3); US (4); ES (4); FR (1)