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Study of loncastuximab tesirine and epcoritamab combination treatment for patients with relapsed or refractory diffuse large B-cell lymphoma

Fast replyRegistered drugNo placebo
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What is this trial about?

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

This study focuses on treating patients with Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma grade 3B, and High-grade B-cell Lymphoma. These are types of blood cancers that affect certain white blood cells called B-cells. The study will test a combination of two medications: loncastuximab tesirine (Zynlonta) given through an intravenous infusion into a vein, and epcoritamab given as an injection under the skin.

The purpose of this research is to determine how well patients respond to this combination treatment over a 12-month period. The medications work in different ways to target and destroy cancer cells - loncastuximab tesirine is an antibody-drug combination that delivers medication directly to cancer cells, while epcoritamab is a specialized antibody that helps the immune system recognize and fight cancer cells.

During the study, participants will receive both medications according to a specific schedule. Patients will have regular check-ups and imaging tests to monitor how their cancer responds to the treatment. The treatment period may last up to 54 weeks, depending on how well the patient responds and tolerates the medications. Throughout the study, doctors will closely monitor patients for any side effects or complications from the treatment.

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

    You will receive two medications during this study: loncastuximab tesirine through an intravenous infusion and epcoritamab as an injection under the skin.

    Your treatment will be monitored for up to 12 months to assess how your body responds to the medications.

  2. Step 2

    Disease monitoring

    Regular imaging scans (PET/CT or MRI) will be performed to measure how your disease responds to treatment.

    Your doctor will assess if your disease is showing complete or partial improvement, or if it remains stable or progresses.

  3. Step 3

    Follow-up period

    Your health will be monitored for up to 2 years to track long-term results.

    Regular check-ups will continue to evaluate your overall survival and whether the disease returns.

    Any side effects will be recorded throughout the entire study period.

  4. Step 4

    Treatment completion

    The study will track how many treatment cycles you received and their duration.

    The total amount of medications you received will be documented.

    Your health status will continue to be monitored for 2 months after completing the treatment.

  5. Step 5

    Extended monitoring

    Additional follow-up assessments will occur at 18 and 24 months to check your response to the treatment.

    The study will continue monitoring your health status until September 2029.

Who can join the trial?

20 criteria

  • Must be 18 years or older
  • Must have confirmed B-cell lymphoma (a type of blood cancer) that has returned or not responded to previous treatment
  • Must be able to understand and sign an informed consent form
  • Must have measurable disease that can be seen on PET/CT scans (special imaging tests)
  • Must have general health status of ECOG 0-2 (able to perform daily activities with some limitations)
  • Must have failed previous treatment with either:
    • First-line therapy containing specific antibodies and chemotherapy, or
    • Second-line CAR-T cell therapy (a type of immune cell therapy)
    • Must have adequate blood test results including:
      • Platelets at least 75,000/mm³
      • Hemoglobin at least 8 g/dL
      • White blood cells (neutrophils) at least 1,000/mm³
      • Must have adequate liver function tests
      • Must have adequate kidney function
      • Must have adequate heart function (ejection fraction above 45%)
      • Must not have received live vaccines within 28 days before screening
      • Must not be taking medications that weaken the immune system (except small doses of prednisone)
      • Must not have participated in other clinical trials within the last 30 days
      • For women who can become pregnant:
        • Must have a negative pregnancy test
        • Must use effective birth control during the study and for 12 months after
        • For men with partners who can become pregnant:
          • Must use effective birth control during the study and for 7 months after
          • Must not donate sperm during this time

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Previous treatment with CAR-T cell therapy (a type of treatment that modifies immune cells to fight cancer)
  • Active or chronic infections including:
    • Hepatitis B (liver infection)
    • Hepatitis C (liver infection)
    • HIV (human immunodeficiency virus)
    • Pregnancy or breastfeeding
    • Major surgery within 4 weeks before starting the study
    • Active heart problems including:
      • Heart failure
      • Irregular heartbeat
      • Recent heart attack
      • Severe kidney or liver problems
      • Active second cancer (other than the one being studied)
      • Mental conditions that could interfere with following study procedures
      • Participation in another clinical trial within 30 days before this study
      • Known allergic reactions to similar treatments
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Investigated drugs

  • Loncastuximab Tesirine

    is a medication specifically designed to treat certain types of blood cancer. It's an antibody-drug that targets and attacks specific cancer cells in patients with lymphoma. This medication works by delivering a toxic substance directly to cancer cells that have a particular protein on their surface, helping to destroy these harmful cells while minimizing damage to healthy cells.

  • Epcoritamab

    is a bispecific antibody treatment that helps the body's immune system fight against lymphoma. It works by connecting immune cells (T-cells) to cancer cells, enabling the immune system to better recognize and destroy the cancer cells. This medication is designed to treat patients whose lymphoma has returned or hasn't responded to previous treatments.

What is already known about the treatment

  • Loncastuximab Tesirine

    An antibody-drug conjugate administered through intravenous infusion, specifically designed to target CD19-positive B-cell malignancies. This medication is currently used in treating various forms of lymphoma, particularly diffuse large B-cell lymphoma (DLBCL), working by delivering a potent cytotoxic agent directly to cancer cells that express CD19 on their surface. It belongs to the class of targeted cancer therapeutics and operates by binding to cancer cells and releasing a toxic payload that causes cell death.

  • Epcoritamab

    A bispecific antibody given through subcutaneous injection that simultaneously targets CD3 on T-cells and CD20 on B-cells, creating a bridge between these cells to activate the immune system against lymphoma. This innovative immunotherapy is being investigated for treating various B-cell lymphomas, including DLBCL and high-grade B-cell lymphoma, and works by redirecting T-cells to eliminate malignant B-cells. It represents a new generation of immunotherapy agents in the treatment of blood cancers, designed to enhance the body's natural immune response against cancer cells.

Investigated diseases

  • Diffuse Large B-cell Lymphoma (DLBCL)

    A fast-growing cancer that develops in the lymphatic system from B-cells, a type of white blood cell. The disease affects lymph nodes and can spread to other parts of the body. It causes lymph nodes to become enlarged, and patients may experience fever, night sweats, and weight loss. DLBCL is the most common type of non-Hodgkin lymphoma in adults.

  • Follicular Lymphoma Grade 3B (FL Grade 3B)

    A specific subtype of blood cancer that develops from B-lymphocytes in the lymphatic system. The term "follicular" refers to the circular pattern that the lymphoma cells form in the lymph nodes. Grade 3B indicates a more aggressive form of follicular lymphoma, where the cancer cells appear larger and divide more quickly than in lower grades.

  • High-Grade B-cell Lymphoma (HGBL)

    An aggressive form of lymphoma that develops from abnormal B-lymphocytes. The term "high-grade" refers to the fact that the cancer cells look very different from normal cells and multiply quickly. This lymphoma can affect multiple lymph nodes and organs simultaneously. The disease typically progresses rapidly if left untreated.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509861-19-01Protocol codeWWU23_0006Estimated enrolment120 patientsSponsorUniversitaet Muenster

sourced from the EU Clinical Trials Register and site verification

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