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Study on the Effects and Safety of Odronextamab for Adults with Previously Treated B-cell Non-Hodgkin Lymphoma

Fast replyInvestigationalNo placebo
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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 the effects of a treatment called Odronextamab in patients with a type of cancer known as B-cell non-Hodgkin lymphoma. This type of cancer affects the lymphatic system, which is part of the body's immune system. The study is specifically looking at patients whose cancer has returned or has not responded to previous treatments. The treatment being tested, Odronextamab, is a special kind of medication known as a bispecific antibody, which is designed to target and attack cancer cells.

The purpose of the study is to evaluate how well Odronextamab works in shrinking tumors and to assess its safety in patients. The study includes several subtypes of B-cell non-Hodgkin lymphoma, such as follicular lymphoma, diffuse large B-cell lymphoma, mantle cell lymphoma, and marginal zone lymphoma. Patients participating in the study will receive the treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will monitor the patients over a period of time to see how their cancer responds to the treatment and to check for any side effects.

Throughout the study, researchers will collect information on how the cancer responds to Odronextamab and any changes in the patients' health. This information will help determine the effectiveness of the treatment and its potential as a new option for patients with B-cell non-Hodgkin lymphoma. The study aims to provide valuable insights into the treatment of this type of cancer and improve future care for patients. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

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

    Enrollment

    Upon joining the study, confirmation of the specific type of B-cell non-Hodgkin lymphoma (NHL) is required. This involves a review of medical history and diagnostic imaging to ensure eligibility.

    Eligibility criteria include having relapsed or refractory B-cell NHL after previous treatments, and a performance status that allows participation.

  2. Step 2

    Initial Assessment

    An initial assessment is conducted to evaluate overall health, including bone marrow, liver, and kidney function. This ensures that the body can handle the treatment.

    Imaging tests such as CT or MRI scans are performed to measure the disease.

  3. Step 3

    Treatment Administration

    The treatment involves the administration of Odronextamab, a concentrate for solution for infusion, given intravenously.

    The dosage and frequency of administration are determined by the study protocol and adjusted based on individual response and tolerance.

  4. Step 4

    Monitoring and Evaluation

    Regular monitoring is conducted to assess the response to treatment. This includes imaging tests and evaluations by healthcare professionals.

    The primary goal is to measure the anti-tumor activity and safety of the treatment using established criteria.

  5. Step 5

    Follow-up

    After completing the treatment phase, follow-up assessments are scheduled to monitor long-term effects and overall health.

    These assessments help in understanding the duration of response and any potential side effects.

Who can join the trial?

12 criteria

  • Patients must have a type of cancer called B-cell non-Hodgkin lymphoma (NHL).
  • For the follicular lymphoma (FL) grade 1-3a group, the diagnosis must be confirmed before joining the study. Patients with FL grade 3b can join a different group.
  • Patients must have a performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • Patients must have good bone marrow, liver, and kidney function as defined in the study rules.
  • Patients should need treatment for their lymphoma at the time of joining the study.
  • For the FL grade 1-3a group, patients must have had their disease return or not respond after at least 2 previous treatments.
  • For the diffuse large B-cell lymphoma (DLBCL) group, patients must have had their disease return or not respond after at least 2 previous treatments.
  • For the mantle cell lymphoma (MCL) group, patients must have had their disease return or not respond after at least one previous treatment and have been treated with a BTK inhibitor, a type of medication.
  • For the marginal zone lymphoma (MZL) group, patients must have had their disease return or not respond after at least 2 previous treatments.
  • For other B-NHL types, patients must have had their disease return or not respond after at least 2 previous treatments. New patients with Burkitt lymphoma and Burkitt-like lymphoma are not being accepted.
  • Patients must have a disease that can be measured using imaging tests like CT or MRI.
  • Both men and women can participate in the study.

Who cannot join the trial?

9 criteria

  • Patients who have a different type of cancer that is not B-cell non-Hodgkin lymphoma (NHL).
  • Patients who have not tried at least two different treatments for their B-cell non-Hodgkin lymphoma (NHL) and found them not to work or their cancer came back.
  • Patients with follicular lymphoma who have not tried at least two treatments, including a specific type of medicine called an anti-CD20 antibody and another type called an alkylating agent.
  • Patients with diffuse large B-cell lymphoma who have not tried at least two treatments, including an anti-CD20 antibody and an alkylating agent.
  • Patients with mantle cell lymphoma who have not tried at least one treatment and have not used a medicine called a Bruton’s tyrosine kinase (BTK) inhibitor.
  • Patients with marginal zone lymphoma who have not tried at least two treatments.
  • Patients with other types of B-cell non-Hodgkin lymphoma who have not tried at least two treatments.
  • Patients who are younger than 18 years old or older than 65 years old.
  • Patients who are not able to understand or agree to the study requirements.
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Investigated drugs

Odronextamab is a medication being studied for its ability to fight cancer in patients with certain types of B-cell non-Hodgkin lymphoma. It is a bispecific antibody, which means it is designed to attach to two different targets on cells. In this case, it targets CD20 and CD3 proteins. The goal of this medication is to help the immune system recognize and destroy cancer cells. It is being tested in patients whose cancer has come back or has not responded to previous treatments.

What is already known about the treatment

Odronextamab – This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating B-cell non-Hodgkin lymphoma (NHL). It is a bispecific antibody that targets CD20 and CD3, aiming to engage the body's immune system to attack cancer cells. Odronextamab is classified as an immunotherapy agent and is being evaluated for its ability to induce tumor responses in patients with various subtypes of B-cell NHL, including those who have not responded to previous treatments.

Investigated diseases

B-cell non-Hodgkin lymphoma (NHL) – This is a type of cancer that originates in the lymphatic system, specifically affecting B-lymphocytes, which are a type of white blood cell. It encompasses various subtypes, including follicular lymphoma, diffuse large B-cell lymphoma, mantle cell lymphoma, and marginal zone lymphoma. The disease typically begins with the abnormal growth of B-cells, leading to the formation of tumors in lymph nodes or other organs. As it progresses, it can spread to other parts of the body, including the bone marrow, spleen, and liver. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The progression and symptoms can vary significantly depending on the specific subtype of B-cell non-Hodgkin lymphoma.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511747-25-00Protocol codeR1979-ONC-1625Estimated enrolment515 patientsSponsorRegeneron Pharmaceuticals Inc.

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