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Study of Epcoritamab for Patients with Relapsed, Progressive, or Refractory B-Cell Lymphoma

Verified siteRegistered drugNo 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 a type of cancer called B-cell lymphoma, which affects a part of the immune system. The trial is testing a new treatment called Epcoritamab, also known by its code name GEN3013. Epcoritamab is a solution for injection that is designed to target specific proteins on the surface of cancer cells. The purpose of the study is to find the best dose of Epcoritamab and to see how well it works in treating B-cell lymphoma.

Participants in the study will receive Epcoritamab through injections under the skin. The study will be conducted in phases, starting with a dose-escalation phase to determine the safest and most effective dose. After this, the study will expand to include more participants to further evaluate the treatment's effectiveness. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of Epcoritamab. The study will also explore whether adjusting the dose can reduce the risk of a side effect known as CRS (Cytokine Release Syndrome), which can cause symptoms like fever and fatigue.

In addition to Epcoritamab, the study may involve other medications such as Paracetamol (also known as acetaminophen), Dexamethasone, Betamethasone, Anakinra, Siltuximab, Diphenhydramine, and Tocilizumab. These medications are used to manage symptoms or side effects during the trial. The study aims to gather information over several years to understand the long-term effects and benefits of Epcoritamab for patients with B-cell lymphoma.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, the patient will be informed about the study's purpose and procedures. The trial is designed to evaluate the safety and effectiveness of a new treatment for B-cell lymphoma, a type of cancer affecting certain white blood cells.

  2. Step 2

    Initial assessment

    The patient will undergo an initial assessment to confirm eligibility. This includes verifying the diagnosis of B-cell lymphoma and ensuring the patient has previously received at least two lines of therapy.

  3. Step 3

    Treatment phase 1: dose escalation

    The patient will receive epcoritamab through subcutaneous injection. The dose will be gradually increased to determine the maximum tolerated dose. The goal is to find the safest and most effective dose for further study.

  4. Step 4

    Treatment phase 2: expansion

    Once the optimal dose is identified, the patient will continue to receive epcoritamab at this dose. The effectiveness of the treatment will be evaluated using criteria that measure tumor response.

  5. Step 5

    Treatment phase 3: optimization

    In this phase, the treatment regimen may be adjusted to reduce the risk of certain side effects. The patient will continue to receive epcoritamab and be monitored for any adverse reactions.

  6. Step 6

    Monitoring and follow-up

    Throughout the trial, the patient will undergo regular monitoring to assess the treatment's impact on their health. This includes blood tests and imaging studies to track changes in the lymphoma.

  7. Step 7

    End of trial

    The trial is expected to conclude by February 2028. At the end of the trial, the patient will have a final assessment to evaluate the overall response to the treatment.

Who can join the trial?

7 criteria

  • Patient must be 18 years of age or older. In some countries, if the legal age is 21, only patients 21 years or older can participate.
  • Patient must have a confirmed diagnosis of **CD20+ mature non-Hodgkin B-cell lymphoma**. This is a type of cancer that affects certain white blood cells.
  • Patient's disease must have returned, worsened, or not responded to previous treatment with an **anti-CD20 monoclonal antibody**. This is a type of medicine used to treat lymphoma.
  • Patient must have received at least two previous treatments for their condition.
  • Patient must have a disease that can be measured using imaging tests.
  • Patient must have an **ECOG performance status** of 0, 1, or 2. This is a scale used to assess how well a patient can perform daily activities. For a specific type of lymphoma called **MCL**, the status must be less than 2.
  • For a specific part of the study, patients must have certain types of lymphoma: **R/R DLBCL**, **FL grades 1-3A**, or **MCL**. These are different subtypes of lymphoma.

Who cannot join the trial?

5 criteria

  • Patients who do not have Lymphoma of B-cell origin cannot participate. Lymphoma is a type of cancer that affects the immune system, and B-cells are a specific type of white blood cell.
  • Patients who are not within the specified age range for the study cannot participate. The age range is determined by the study and may include specific age groups.
  • Patients who are not part of the specified clinical trial groups cannot participate. These groups are defined by the study based on certain characteristics or conditions.
  • Patients who are not female or male subjects cannot participate. The study is open to both genders.
  • Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups that require special protection in research.
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Investigated drugs

GEN3013 is a medication being studied in this clinical trial. It is being tested in patients who have B-cell lymphoma that has returned, is getting worse, or has not responded to previous treatments. The trial aims to find the best dose of GEN3013 that patients can tolerate and to see how effective it is in treating the lymphoma. The study also looks at whether changing the way the medication is given can help reduce the risk of certain side effects.

What is already known about the treatment

GEN3013 – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating B-cell lymphoma, particularly in cases where the disease has relapsed, progressed, or is refractory. The main therapeutic indication for GEN3013 is B-cell lymphoma, a type of cancer that affects the lymphatic system. At the molecular level, GEN3013 works by targeting specific proteins on the surface of B-cells, helping the immune system to recognize and destroy these cancerous cells. It is classified pharmacologically as a monoclonal antibody, which is a type of targeted therapy designed to interfere with specific pathways involved in cancer cell growth and survival.

Investigated diseases

Lymphoma of B-cell origin – This is a type of cancer that begins in the B cells, which are a type of white blood cell responsible for producing antibodies. It typically starts in the lymph nodes but can also affect other organs. The disease progresses as the cancerous B cells multiply uncontrollably, forming tumors in the lymphatic system. Over time, it can spread to other parts of the body, including the spleen, liver, and bone marrow. Symptoms may include swollen lymph nodes, fatigue, fever, and weight loss. The progression and symptoms can vary depending on the specific subtype of B-cell lymphoma.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase I/IITrial ID2023-504802-12-00Protocol codeGCT3013-01Estimated enrolment707 patientsSponsorGenmab A/S

sourced from the EU Clinical Trials Register and site verification

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