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Follicular LymphomaPhase 1/2SIDNEYNCT04669171

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

A Phase 1/2 study testing EO2463, lenalidomide and rituximab in people with Follicular Lymphoma and Marginal Zone Lymphoma, run by Enterome at 11 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Follicular Lymphoma, Marginal Zone Lymphoma
What is being tested?
EO2463, lenalidomide and rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
11 sitesin 4 countries
Study dates
5 Jul 2021to 30 May 2034
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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.
  • 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.
  • 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.
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  • 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.

Who cannot join

  • 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 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).
  • Patients with prior exposure to EO2463.
  • Patients treated with immunotherapy (meaning immunostimulatory or immunosuppressive therapy; beside excluded, or allowed, compounds per other inclusion/exclusion criteria specifications), radionuclide therapy, radiotherapy, cytoreductive therapy, or received treatment with any other investigational agent within 28 days before the first EO2463 administration.
  • 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.
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  • 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.

Trial locations and contacts

11 sites in 4 countries.

11 sites in 4 countries

United States4 sites

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Mayo Clinic

    Rochester, Minnesota, 55905

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

    Rochester, New York, 14642

  • University of Washington-Seattle Cancer Care Alliance

    Seattle, Washington, 98109

Other trials in United States

Spain4 sites

  • University Hospital Vall d'Hebron, Institute of Oncology

    Barcelona

  • Clinica Universidad de Navarra

    Madrid

  • Clinica Universidad de Navarra

    Pamplona

  • Hospital Clinico Universitario de Salamanca

    Salamanca

Other trials in Spain

Italy2 sites

  • IRCCS Policlinico San Matteo Foundation - University of Pavia

    Naples

  • IRCCS Policlinico San Matteo Foundation - University of Pavia

    Pavia

Other trials in Italy

France1 site

  • CHU d'Amiens-Picardie - Hopital SUD

    Amiens

Other trials in France

About this study

Official title: 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

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

Read the 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

Being tested
EO2463, lenalidomide, rituximab
Keywords
Follicular Lymphoma, Marginal Zone Lymphoma, Rituximab, Lenalidomide, Peptide-based immunotherapy
Medical subject headings
Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EO2463Biological

    Multiple dose of EO2463

  • lenalidomideDrug

    Also called Revlimid

    D1-21 of 4-weekly cycles

  • rituximabBiological

    Also called MabThera

    Multiple doses of rituximab

Study groups in NCT04669171
Study groupRoleWhat they receive
Cohort 1ExperimentalSafety 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.
Receives: Biological: EO2463; Drug: lenalidomide; Biological: rituximab
Cohort 2ExperimentalAnticipated approximatively 25 previously untreated patients with FL or MZL with an evaluation of EO2463 monotherapy (at the established dose in Cohort 1).
Receives: Biological: EO2463
Cohort 3ExperimentalAnticipated 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).
Receives: Biological: EO2463; Biological: rituximab
Cohort 4ExperimentalAnticipated 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.
Receives: Biological: EO2463; Drug: lenalidomide; Biological: rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 24 months

  2. Phase 2: Overall Response Rate

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

    Measured: Up to 24 months

  3. Phase 2: Complete Response Rate

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

    Measured: Up to 24 months

Secondary outcomes (2)

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

    Immunogenicity will be assessed by interferon-Gamma (IFN-Γ) enzyme-Linked immunospot , and/or by intracellular cytokines staining, and/or multimers staining assays.

    Measured: Up to 24 months

  2. Evaluation of Overall Survival

    The time interval from the date of first study treatment administration to the date of death due to any cause

    Measured: Up to 7 years after last patient enrolled

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2020
  2. Study start5 Jul 2021
  3. Primary completion30 May 2029 (estimated)
  4. Study completion30 May 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04669171
Sponsor's protocol ID
EONHL1-20
Acronym
SIDNEY
Status last verified
Nov 2026
First submitted
8 Dec 2020
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing EO2463, lenalidomide and rituximab in people with Follicular Lymphoma and Marginal Zone Lymphoma, run by Enterome at 11 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Spain, Italy, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Recommended Phase 2 Dose | Adverse Events Assessment | (time frame: Up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04669171.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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