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Study of Loncastuximab Tesirine and Epcoritamab for Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma, High-grade B-cell Lymphoma, or Follicular Lymphoma Grade 3B

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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 combining two treatments, Loncastuximab Tesirine and Epcoritamab (GEN3013), for certain types of lymphoma, which is a cancer of the lymphatic system. The specific types of lymphoma being studied are Diffuse Large B-cell Lymphoma (DLBCL), High-grade B-cell Lymphoma (HGBL), and Follicular Lymphoma (FL) grade 3B. These are conditions where the body's lymphocytes, a type of white blood cell, grow uncontrollably.

The purpose of the study is to evaluate how well these treatments work together in patients whose lymphoma has returned or has not responded to previous treatments. Loncastuximab Tesirine is an antibody-drug conjugate, which means it is designed to deliver a drug directly to cancer cells, while Epcoritamab is a bispecific antibody that helps the immune system target and destroy cancer cells. The study will involve administering these treatments to participants and monitoring their response over a period of time, up to 12 months, to see if the cancer shrinks or disappears.

Participants in the study will receive the treatments through injections, with Loncastuximab Tesirine given intravenously (through a vein) and Epcoritamab given subcutaneously (under the skin). The study aims to determine the best overall response rate, which includes both complete and partial remissions, and will also look at other outcomes such as progression-free survival and overall survival. The study will help researchers understand the potential benefits and risks of this combination therapy for patients with these types of lymphoma.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and consent

    Upon joining the study, you will have an initial visit where the study team will explain the trial in detail. You will be asked to read and sign an informed consent form, which confirms your understanding and willingness to participate in the study.

  2. Step 2

    Screening tests

    You will undergo a series of screening tests to ensure you meet the study's eligibility criteria. These tests may include blood tests, imaging scans like PET/CT, and other assessments to evaluate your health status and the extent of your lymphoma.

  3. Step 3

    Treatment initiation

    Once eligibility is confirmed, you will begin treatment with the study medications. The treatment involves two drugs: epcoritamab and loncastuximab tesirine.

    Epcoritamab is administered as a solution for injection under the skin (subcutaneous use).

    Loncastuximab tesirine is given as a solution for infusion into a vein (intravenous use).

  4. Step 4

    Treatment schedule

    The treatment will be administered in cycles. The exact dosage, frequency, and duration of each medication will be determined by the study protocol and your healthcare provider. You will receive regular doses of both medications as part of the treatment plan.

  5. Step 5

    Regular monitoring

    Throughout the study, you will have regular visits to monitor your health and response to the treatment. This includes physical exams, blood tests, and imaging scans to assess the effectiveness of the treatment and any side effects.

  6. Step 6

    Response assessment

    Your response to the treatment will be evaluated periodically. The main goal is to determine the best overall response rate, including complete and partial remissions, achieved up to 12 months of treatment.

  7. Step 7

    End of treatment

    The study treatment will continue for a specified period, up to 12 months, unless there are reasons to stop earlier, such as significant side effects or disease progression. After completing the treatment, you will have a final assessment to evaluate your overall response and health status.

  8. Step 8

    Follow-up

    After the treatment phase, you will enter a follow-up period where your health will be monitored for any long-term effects or recurrence of the disease. This may involve periodic visits and tests as determined by the study protocol.

Who can join the trial?

21 criteria

  • You must be 18 years or older.
  • You must have a confirmed diagnosis of one of the following: Diffuse large B-cell lymphoma (DLBCL), High-grade B-cell lymphoma (HGBL), or Follicular lymphoma (FL) grade 3B.
  • You should not be taking any medication that reduces the number or activity of T-cells, except for a small dose of prednisone (up to 10 mg daily) if needed for disease control.
  • You should not have taken any experimental drug within 30 days before starting the study, unless it was approved for emergency use.
  • You should not have received any live vaccines within 28 days before the study and should not need any during the study, except for COVID-19 vaccines, which are allowed.
  • You must need treatment based on your symptoms or disease severity, as determined by the study doctor.
  • Your Eastern Cooperative Oncology Group (ECOG) performance status should be between 0 and 2. This is a scale used to assess how your disease affects your daily living abilities.
  • You must have relapsed or refractory disease and have failed previous treatments, including first-line anti-CD20 therapy or second-line CAR-T cell therapy.
  • You must have at least one measurable disease site, confirmed by a PET/CT scan or MRI.
  • You must be able to understand and sign a written consent form to participate in the study.
  • If you are a woman of childbearing potential or a sexually active man, you must use a highly effective method of birth control during and after the study.
  • Your total bilirubin level should be no more than 1.5 times the normal limit, unless you have certain conditions like Gilbert syndrome or liver involvement by lymphoma.
  • If you are a woman of childbearing potential, you must have a negative pregnancy test before joining the study.
  • Any side effects from previous lymphoma treatments should be resolved to a mild level, except for certain conditions like CRS or ICANS, which should be fully resolved.
  • Your ALT, AST, and GGT levels should be no more than 2.5 times the normal limit, or 5 times if you have liver involvement by lymphoma.
  • Your glomerular filtration rate (GFR) should be at least 45 mL/min/1.73 m², which measures how well your kidneys are working.
  • Your prothrombin time/INR/aPTT should be no more than 1.5 times the normal limit, unless you are on blood thinners.
  • Your platelet count should be at least 75,000/mm³ without a transfusion in the past 7 days.
  • Your hemoglobin level should be at least 8 g/dL.
  • Your absolute neutrophil count should be at least 1,000/mm³ without growth factors for at least 72 hours.
  • Your left ventricular ejection fraction should be more than 45%, which measures how well your heart is pumping blood.

Who cannot join the trial?

8 criteria

  • Patients with any other type of cancer that is not Diffuse large B-cell lymphoma (DLBCL), High-grade B-cell lymphoma (HGBL), or Follicular lymphoma (FL) grade 3B cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to provide informed consent cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with severe uncontrolled medical conditions that could interfere with the study cannot participate.
  • Patients who have received certain treatments or medications that could interfere with the study cannot participate.
  • Patients with known allergies to the study medication or its components cannot participate.
  • Patients who have participated in another clinical trial within a certain time frame before this study cannot participate.
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Investigated drugs

  • Loncastuximab Tesirine

    is a type of medication used in cancer treatment. It is designed to target and attach to specific cancer cells, particularly in a type of cancer called Diffuse Large B-cell Lymphoma (DLBCL). Once attached, it delivers a toxic substance directly to the cancer cells, helping to destroy them while minimizing damage to healthy cells. This targeted approach aims to improve the effectiveness of treatment and reduce side effects compared to traditional chemotherapy.

  • Epcoritamab

    is another medication used in the treatment of certain types of lymphoma, including DLBCL. It works by engaging the body's immune system to recognize and attack cancer cells. Epcoritamab is a type of therapy known as a bispecific antibody, which means it can bind to two different targets at the same time. This dual action helps to bring immune cells closer to the cancer cells, enhancing the body's natural ability to fight the cancer.

What is already known about the treatment

  • Loncastuximab Tesirine

    This medication is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating certain types of lymphoma, specifically diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBL), and follicular lymphoma (FL) grade 3B. The drug works by targeting and binding to a specific protein on the surface of cancer cells, delivering a toxic substance that helps kill these cells. It is classified as an antibody-drug conjugate, which is a type of targeted cancer therapy designed to minimize damage to healthy cells.

  • Epcoritamab

    This medication is administered via subcutaneous injection, which means it is injected under the skin. It is being explored in clinical trials for its potential to treat relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Epcoritamab works by engaging the body's immune system to recognize and attack cancer cells, specifically by binding to proteins on the surface of these cells and activating immune cells to destroy them. It is classified as a bispecific antibody, a type of immunotherapy that helps the immune system target cancer more effectively.

Investigated diseases

  • Diffuse large B-cell lymphoma (DLBCL)

    This is a type of non-Hodgkin lymphoma that originates from B-cells, a type of white blood cell. It typically presents as a rapidly growing mass, often in lymph nodes, but can also occur in other organs. The disease progresses quickly, with symptoms such as swelling of lymph nodes, fever, night sweats, and weight loss. DLBCL can spread to other parts of the body, including the bone marrow and central nervous system. The progression involves the rapid division and accumulation of abnormal B-cells. It is the most common type of non-Hodgkin lymphoma in adults.

  • High-grade B-cell lymphoma (HGBL)

    This is an aggressive form of non-Hodgkin lymphoma characterized by the rapid growth of abnormal B-cells. It often presents with symptoms such as enlarged lymph nodes, fever, night sweats, and weight loss. HGBL can affect various parts of the body, including lymph nodes, spleen, and bone marrow. The disease progresses quickly, with a high potential for spreading to other organs. It is associated with certain genetic abnormalities that contribute to its aggressive nature. The rapid progression requires prompt medical attention.

  • Follicular lymphoma (FL) grade 3B

    This is a subtype of follicular lymphoma, a type of non-Hodgkin lymphoma that arises from B-cells. Grade 3B indicates a more aggressive form compared to other grades of follicular lymphoma. It typically presents with enlarged lymph nodes and can involve the bone marrow and other organs. The disease progresses with the accumulation of abnormal B-cells in lymphoid tissues. Symptoms may include fatigue, fever, night sweats, and unintended weight loss. The progression can vary, but grade 3B is generally more aggressive than lower grades.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509861-19-00Protocol codeWWU23_0006Estimated enrolment104 patientsSponsorUniversitaet Muenster

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