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A study to evaluate the effectiveness of epcoritamab in patients with Waldenström's macroglobulinemia that has returned or has not responded to previous treatments.

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What is this trial about?

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

This study is being conducted to investigate the effects of a medication called epcoritamab (GEN3013) in people with Waldenstrom’s macroglobulinemia. This is a rare type of blood cancer where the body produces too much of a specific protein. The study focuses on patients with relapsed or refractory disease, which means the cancer has either returned after a period of improvement or has not responded to previous medical treatments.

The investigation is divided into two parts to first determine the most appropriate amount of the medicine to give and then to see how well it works. The medication is administered as a subcutaneous injection, which is a type of injection given into the fatty tissue just under the skin. Participants will receive the treatment for a series of cycles to monitor how the disease responds over time.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Phase ib: dose determination

    Participation begins with the administration of epcoritamab, which is a solution for injection given under the skin (subcutaneous injection).

    The goal of this stage is to find the recommended dose for the next phase by monitoring for any dose-limiting toxicities, which are serious side effects that might prevent increasing the amount of medicine.

  2. Step 2

    Phase ii: efficacy evaluation

    The epcoritamab treatment continues for up to 12 cycles.

    The effectiveness of the medicine is measured by looking for a major response, which means the disease is either completely gone (complete remission) or has significantly decreased (very good partial response or partial response).

    Further monitoring is conducted after 12 and 24 cycles to track the response rates, which describe how much the disease has shrunk or stabilized.

    Various factors are tracked, such as how long the response lasts, the time it takes to see a response, and the progression-free survival, which is the time from the first dose until the disease gets worse or death occurs.

    The total time on treatment and the overall survival are also recorded.

    The time until a new treatment is needed and the treatment-free survival, which is the time between the last dose and starting a new therapy, are monitored.

    safety is tracked by recording the type and severity of adverse events, which are unwanted side effects, and any adverse events of special interest.

    The quality of life is assessed using specific health-related questionnaires.

Who can join the trial?

13 criteria

  • You must be at least 18 years old.
  • You must have a diagnosis of Waldenstrom’s macroglobulinemia, which is a type of blood cancer.
  • Your cancer must be relapsed (it has returned after treatment) or refractory (it has not responded to treatment).
  • You must have received at least one prior treatment for this cancer, specifically including either a BTK-inhibitor or an anti-CD20 antibody combined with chemotherapy.
  • Your disease must be measurable, meaning there is a detectable amount of IgM M-protein (a specific protein produced by the cancer cells) in your blood.
  • A bone marrow test must show that your cancer cells are CD20 positive, meaning they have a specific marker on their surface that the medicine can target.
  • You must test negative for Hepatitis B and Hepatitis C, which are viral infections of the liver. If you have had these infections in the past, you must have a negative PCR test, which is a highly sensitive test used to check for the presence of the virus's genetic material.
  • Women who can become pregnant must have a negative pregnancy test at the start of the study.
  • Both women and men must agree to use effective contraception (methods to prevent pregnancy) during the trial and for 4 months after the last dose of medicine.
  • You must be able to provide informed consent, which means you understand the study and agree to participate in writing.
  • You must have an acceptable physical status, meaning you are generally able to perform daily activities and carry out light work.
  • Your blood counts must be within safe levels, including enough hemoglobin (the part of red blood cells that carries oxygen), a sufficient absolute neutrophil count (white blood cells that fight infection), and a safe platelet count (cells that help blood clot).
  • Your organ function must be healthy, specifically your renal function (how well your kidneys work), your liver function (measured by levels of enzymes like ALT and AST and bilirubin), and your coagulation status (how well your blood clots).

Who cannot join the trial?

25 criteria

  • People with large cell transformation (a change where cancer cells become more aggressive), involvement of the central nervous system (the brain and spinal cord), Bing Neel Syndrome, or AL Amyloidosis (a condition where abnormal proteins build up in organs).
  • Anyone with suspected active or untreated latent tuberculosis (a form of tuberculosis where the bacteria are present but dormant in the body).
  • People with severe cardiovascular disease, such as arrhythmias (irregular heartbeats) that need long-term medicine, congestive heart failure, or ischemic heart disease (reduced blood flow to the heart).
  • People with severe pulmonary dysfunction (serious lung problems).
  • People with severe neurological dysfunction (serious problems with the nervous system) or psychiatric disease (mental health conditions).
  • People with any other severe or uncontrolled medical condition, such as uncontrolled diabetes, infections, or high blood pressure.
  • Anyone with a history of active cancer, except for certain minor skin cancers, early-stage cervical cancer, certain bladder cancers, specific prostate cancers, or any cancer that was fully cured for more than 2 years.
  • People with uncontrolled HIV infection, unless the virus is successfully suppressed and certain immune cell counts are stable.
  • People with an active HBV (Hepatitis B) or HCV (Hepatitis C) infection.
  • People with symptomatic IgG or IgA (specific types of proteins in the blood) or certain types of LPL (a type of blood cancer) that do not produce proteins.
  • People with uncontrolled hyperviscosity syndrome (blood that is too thick) or those who have had plasmapheresis (a process to filter the blood) within the last 35 days.
  • People with peripheral neuropathy (nerve damage causing numbness or pain in the hands or feet) that is severe.
  • People who have received live attenuated vaccines (weakened versions of a virus used in vaccines) within the last 28 days.
  • People who have had major surgery within the last 28 days.
  • People who are pregnant or breastfeeding.
  • People currently taking part in another clinical trial involving medicinal products.
  • Anyone with social, family, or living situation issues that might make it difficult to follow the study rules and schedule.
  • Any condition that the doctor believes makes participating in the study unsafe or not in the best interest of the patient.
  • People who have had certain recent treatments, including chemotherapy, rituximab, bortezomib, BTK-inhibitors (a type of targeted cancer medicine), or autoSCT (a procedure to replace bone marrow using the patient's own cells) within specific timeframes.
  • People who have had a solid organ transplant or an allogeneic hematopoietic stem cell transplantation (a transplant using cells from a donor).
  • People who have previously used a CD3 x CD20 bispecific antibody (a specific type of immune system medicine).
  • People with autoimmune disease or conditions requiring long-term or high-dose immunosuppressive therapy (medicines that lower the immune system).
  • People with a history of hypersensitivity or anaphylaxis (severe allergic reactions) to the study drugs.
  • People with active bleeding or a bleeding diathesis (a tendency to bleed excessively, such as hemophilia).
  • People with an ongoing infection (bacterial, viral, fungal, etc.) that requires medicine, including COVID-19, at the time of joining or within 2 weeks before the first dose.
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Investigated drugs

Epcoritamab is a medication being tested to see if it can help treat patients whose Waldenström macroglobulinemia has returned or did not respond to previous treatments. It is given as an injection under the skin.

What is already known about the treatment

Epcoritamab - This medication is an injectable solution administered through a shot under the skin to treat certain types of blood cancer. Currently being studied in clinical trials, it is used for patients whose Waldenstrom’s macroglobulinemia has returned or did not respond to previous treatments. It belongs to a group of drugs called bispecific antibodies, which work by acting like a bridge to bring the body's own immune cells directly to the cancer cells so they can destroy them.

Investigated diseases

Waldenström macroglobulinemia - This is a type of slow-growing blood cancer that originates in the bone marrow. It occurs when abnormal plasma cells produce large amounts of a specific protein called IgM. As the disease progresses, these excess proteins can build up in the bloodstream. This accumulation can lead to changes in blood viscosity and affect how blood flows through the body. The abnormal cells also tend to collect in various tissues and organs over time.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2025-522295-91-00Protocol codeHOVON 178 WMEstimated enrolment28 patientsSponsorHaemato Oncology Foundation For Adults Netherlands

sourced from the EU Clinical Trials Register and site verification

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