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Study of EO2463, Lenalidomide, and Rituximab for Patients with Indolent Non-Hodgkin's Lymphoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called Indolent Non-Hodgkin's Lymphoma, which includes subtypes like Follicular Lymphoma and Marginal Zone Lymphoma. The trial is investigating a new treatment called EO2463, which is a vaccine therapy derived from microbial peptides. The study will explore the effects of EO2463 both as a standalone treatment and in combination with other medications, specifically Lenalidomide and Rituximab. Lenalidomide is a medication that helps modulate the immune system, while Rituximab is an antibody used to target specific cancer cells.

The purpose of the study is to determine the appropriate dose of EO2463 and to assess its safety when used alone and in combination with Lenalidomide and Rituximab. The trial will be conducted in two phases. In the first phase, the focus will be on finding the right dose and ensuring the treatment is safe. In the second phase, the study will look at how well the treatment works in reducing the cancer according to specific criteria. Participants will receive EO2463 through an injection under the skin, and some may also receive Lenalidomide in capsule form or Rituximab through an infusion.

Throughout the study, participants will be monitored for any side effects and changes in their health. The trial aims to provide valuable information on the effectiveness and safety of EO2463, potentially offering a new treatment option for patients with Indolent Non-Hodgkin's Lymphoma. The study is expected to continue until 2026, with ongoing assessments to ensure the well-being of participants and the collection of necessary data.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The trial begins with the administration of EO2463, a novel cancer vaccine. This phase is designed to determine the appropriate dosage for future phases and to assess the safety of the treatment.

    During this phase, EO2463 is given as a monotherapy, meaning it is the only treatment administered. The duration of this phase varies depending on individual response and safety assessments.

  2. Step 2

    Combination treatment phase

    Following the initial phase, EO2463 is combined with other medications to evaluate the safety and effectiveness of these combinations.

    The medications used in combination include lenalidomide and rituximab. Lenalidomide is taken orally, while rituximab is administered as a solution for infusion.

    The specific combination and dosage depend on the cohort to which the patient is assigned. This phase aims to confirm the safety of EO2463 when used with these additional treatments.

  3. Step 3

    Response assessment phase

    Throughout the trial, the patient's response to the treatment is monitored using the Lugano Classification, a system used to evaluate the effectiveness of lymphoma treatments.

    This phase involves regular assessments to determine the objective response rate, which measures how well the cancer responds to the treatment.

  4. Step 4

    Safety monitoring phase

    Safety is a primary concern throughout the trial. Patients are monitored for any adverse effects or complications that may arise from the treatment.

    This includes tracking any side effects, changes in blood cell counts, and other laboratory abnormalities. The goal is to ensure that the treatment is safe and to manage any potential risks.

  5. Step 5

    Follow-up phase

    After completing the treatment phases, patients enter a follow-up period. This phase involves regular check-ups to monitor the long-term effects of the treatment.

    The follow-up phase helps to gather data on the overall survival and progression-free survival of patients, providing valuable information for future research and treatment development.

Who can join the trial?

15 criteria

  • Patients must have a type of cancer called **Indolent Non-Hodgkin's Lymphoma**, which includes **Follicular Lymphoma** or **Marginal Zone Lymphoma**.
  • Patients must be **18 years or older**.
  • Patients must be **HLA-A2 positive**, which is a specific genetic marker.
  • Patients must have a **measurable disease**, meaning a lymph node or tumor mass that is at least 1.5 cm in size.
  • Patients must be able to attend scheduled visits, follow the treatment plan, and undergo necessary tests and procedures.
  • Patients must have received and understood the information about the study and provided written consent to participate.
  • For certain groups, patients must have had a **relapsed or refractory** condition, meaning the cancer has returned or not responded to previous treatment, and have received at least one prior treatment.
  • For other groups, patients must have a **newly diagnosed** condition that has not been treated before, except for some specific cases of radiotherapy.
  • Patients must have a specific **performance status** score, which measures their ability to perform daily activities, ranging from 0 to 2.
  • Patients must have a **low tumor burden**, meaning the cancer is not very advanced or causing severe symptoms.
  • Patients must not need standard treatment according to their doctor, or they must need treatment based on their doctor's assessment.
  • Patients must be either male or non-pregnant, non-breastfeeding females. Females of childbearing potential must have a negative pregnancy test and use effective birth control methods.
  • Male patients with female partners of childbearing potential must use condoms and ensure their partners use effective birth control.
  • For patients receiving **rituximab**, females must use effective birth control during and for 12 months after treatment.
  • For patients receiving **lenalidomide**, females must avoid pregnancy and use two reliable birth control methods before, during, and after treatment. Males must use condoms and not donate sperm during and after treatment.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer that are not the specific types being studied.
  • Patients who have had a different cancer treatment recently.
  • Patients with serious health problems that could affect their safety during the trial.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures.
  • Patients with allergies to the study medications.
  • Patients who have participated in another clinical trial recently.
  • Patients with infections that are not well controlled.
  • Patients with certain heart conditions.
  • Patients with liver or kidney problems that are severe.
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Investigated drugs

  • EO2463

    is a new type of vaccine made from microbial peptides. It is being tested to see how well it works on its own and how safe it is when used with other treatments for patients with a type of cancer called indolent Non-Hodgkin's Lymphoma.

  • Lenalidomide

    is a medication that helps the immune system fight cancer. It is being tested in combination with EO2463 to see if it can improve the treatment's effectiveness for patients with indolent Non-Hodgkin's Lymphoma.

  • Rituximab

    is a medication that targets specific cells in the immune system. It is used in combination with EO2463 to determine if it can enhance the treatment's ability to fight indolent Non-Hodgkin's Lymphoma.

What is already known about the treatment

  • EO2463

    This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating indolent Non-Hodgkin's Lymphoma, including Follicular Lymphoma and Marginal Zone Lymphoma. It is a novel microbial-derived peptide therapeutic vaccine, and its main therapeutic indication is to stimulate the immune system to target and destroy cancer cells. At the molecular level, EO2463 works by presenting specific peptides to the immune system, which helps in recognizing and attacking lymphoma cells. It falls under the pharmacological classification of therapeutic vaccines.

  • Lenalidomide

    This medication is taken orally in the form of capsules and is well-established in medical literature for its use in treating various types of blood cancers, including Non-Hodgkin's Lymphoma. It is primarily indicated for its ability to modulate the immune system and inhibit the growth of cancer cells. Lenalidomide works at the molecular level by affecting the immune system and directly targeting cancer cells to prevent their proliferation. It is classified as an immunomodulatory agent.

  • Rituximab

    Administered through intravenous infusion, rituximab is a well-known medication used in the treatment of Non-Hodgkin's Lymphoma and other autoimmune diseases. Its main therapeutic indication is to target and destroy specific types of B-cells, which are involved in the progression of lymphoma. At the molecular level, rituximab binds to the CD20 protein found on the surface of B-cells, leading to their destruction. It is classified as a monoclonal antibody.

Investigated diseases

Indolent Non-Hodgkin's Lymphoma – This is a type of cancer that affects the lymphatic system, which is part of the body's immune system. It progresses slowly and is characterized by the presence of abnormal lymphocytes, a type of white blood cell. The disease can manifest in various forms, including Follicular Lymphoma and Marginal Zone Lymphoma. Follicular Lymphoma typically presents with painless swelling of lymph nodes, while Marginal Zone Lymphoma may involve the spleen or stomach. Over time, the disease can spread to other parts of the body, including the bone marrow and blood. Despite its slow progression, it requires monitoring to manage symptoms and prevent complications.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-509254-58-00Protocol codeEONHL1-20Estimated enrolment54 patientsSponsorEnterome

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