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Study of Loncastuximab Tesirine for Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma or High-Grade B-Cell Lymphoma After CAR T-Cell Therapy

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 clinical trial is focused on studying the effects of a treatment called loncastuximab tesirine on patients with certain types of lymphoma, specifically Diffuse Large B-Cell Lymphoma (DLBCL) and High Grade B-Cell Lymphoma (HGBCL). These are types of blood cancers that affect the lymphatic system, which is part of the body's immune system. The study is particularly interested in patients whose disease has returned or not responded to a previous treatment known as CAR T-cell therapy.

The purpose of the study is to assess how effective loncastuximab tesirine is in treating these conditions. The treatment is given as an infusion, which means it is administered directly into the bloodstream through a vein. Participants in the study will receive this treatment over a period of time, and their response to the treatment will be monitored. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

Throughout the study, researchers will observe how the disease responds to the treatment, including whether it shrinks or disappears, and how long any positive effects last. They will also monitor the overall health and survival of the participants, as well as any side effects that may occur. The study aims to provide valuable information on the potential benefits and risks of using loncastuximab tesirine for these types of lymphoma.

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

    Joining the study

    Upon joining the study, you will be required to provide written, informed consent. This means you agree to participate after understanding the details and potential risks of the study.

    You will undergo a series of initial assessments to confirm eligibility, including a review of your medical history and current health status.

  2. Step 2

    Initial assessments

    You will have tests to confirm the diagnosis of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBCL).

    These tests may include imaging studies like PET-CT or MRI to measure the disease.

  3. Step 3

    Treatment administration

    You will receive the study medication, loncastuximab tesirine, through an intravenous infusion. This means the medication will be given directly into your vein.

    The dosage and frequency of the medication will be determined by the study protocol and your healthcare team.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up visits will be scheduled to monitor your response to the treatment and any side effects. These visits will include physical exams, blood tests, and imaging studies.

    The study team will assess the overall response rate, which measures how well the treatment is working.

  5. Step 5

    End of treatment

    At the end of the treatment period, final assessments will be conducted to evaluate the effectiveness of the medication and your overall health status.

    You will be informed about the results and any further steps or treatments that may be necessary.

Who can join the trial?

20 criteria

  • Must be a male or female aged 18 years or older.
  • Must be willing and able to give written, informed consent to participate in the study.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, which is a scale used to assess how a disease affects a patient's daily living abilities.
  • Must have a confirmed diagnosis of Diffuse Large B-Cell Lymphoma (DLBCL) or High-Grade B-Cell Lymphoma (HGBCL) at the last relapse, as defined by the 2016 World Health Organization (WHO) classification. This includes:
    • DLBCL, Not Otherwise Specified (NOS)
    • Transformed DLBCL from indolent lymphoma
    • HGBCL with MYC and BCL2 and/or BCL6 rearrangements (double/triple hit)
    • Must have failed CAR T-cell therapy, which means:
      • Progressive disease at any time
      • Partial remission or stable disease 3 months after CAR T-cell infusion
      • Must have measurable disease as defined by the 2014 Lugano Classification, assessed by positron-emission tomography (PET)-computed tomography (CT) or by CT or MRI if the tumor is not FDG-avid on screening PET-CT.
      • Previous treatment with loncastuximab tesirine is allowed if the patient was in complete or partial remission at the time of stopping the drug.
      • Women of childbearing potential must have a negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days before starting the study drug.
      • Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 9 months after the last dose of loncastuximab tesirine. Men with female partners who are of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 6 months after the last dose.
      • Must have adequate renal, hepatic, pulmonary, and cardiac function, which includes:
        • Creatinine clearance of at least 40 ml/min
        • Serum alanine aminotransferase/aspartate aminotransferase levels no more than 2.5 times the upper limit of normal (ULN)
        • Total bilirubin no more than 1.5 times the ULN, except in subjects with Gilbert's syndrome
        • Known history of left ventricular ejection fraction (LVEF) of at least 50%, unless the institutional lower limit of normal is lower
        • Baseline oxygen saturation greater than 92% on room air and no more than Grade 1 shortness of breath
        • Must have adequate bone marrow function without needing ongoing blood product or granulocyte-colony stimulating factor support, meeting the following criteria:
          • Absolute neutrophil count of at least 1.0 × 106/dL
          • Hemoglobin of at least 9.0 g/dL
          • Platelets of at least 50 × 106/dL

Who cannot join the trial?

9 criteria

  • Patients who have not been diagnosed with **relapsed/refractory DLBCL** or **HGBCL**. These are specific types of blood cancer.
  • Patients who have not failed **CAR T-cell therapy**. This is a type of treatment that uses the patient's own modified immune cells to fight cancer.
  • Patients who are not within the specified age range for the study.
  • Patients who are not willing or able to follow the study procedures.
  • Patients who have other medical conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients who have a history of certain other diseases or conditions that the study excludes.
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Investigated drugs

Loncastuximab Tesirine is a type of targeted cancer treatment known as an antibody-drug conjugate. It is designed to find and attach to a specific protein found on the surface of certain cancer cells, such as those in diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBCL). Once attached, it delivers a powerful drug directly into the cancer cell, which can help to kill the cancer cells and stop them from growing. This treatment is being tested in patients whose disease has continued to progress even after receiving CAR T-cell therapy, which is another form of cancer treatment.

What is already known about the treatment

Loncastuximab Tesirine – Loncastuximab Tesirine is administered as 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 patients with certain types of lymphoma, specifically those who have not responded to CAR T-cell therapy. The main therapeutic use of this medication is for patients with relapsed or refractory Diffuse Large B-Cell Lymphoma (DLBCL) or High Grade B-Cell Lymphoma (HGBCL). At the molecular level, it works by targeting and binding to a specific protein on the surface of cancer cells, delivering a toxic substance that helps to kill these cells. It is classified as an antibody-drug conjugate, which is a type of targeted cancer therapy.

Investigated diseases

  • Diffuse Large B-Cell Lymphoma (DLBCL)

    This is a type of non-Hodgkin lymphoma that originates in the B-cells, which are a type of white blood cell. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, bone marrow, or other organs. The disease often begins with a painless swelling in the neck, armpit, or groin. As it progresses, it can cause symptoms such as fever, night sweats, and weight loss. DLBCL can spread to other parts of the body, including the central nervous system. The progression of the disease can vary, with some cases advancing quickly while others may develop more slowly.

  • High-Grade B-Cell Lymphoma (HGBCL)

    This is an aggressive form of non-Hodgkin lymphoma that involves B-cells. It is known for its rapid growth and tendency to spread quickly to other parts of the body. HGBCL often presents with enlarged lymph nodes, fever, night sweats, and unexplained weight loss. The disease can affect various organs, including the liver, spleen, and bone marrow. As it progresses, it may lead to complications due to its aggressive nature. The course of the disease can be unpredictable, with some cases responding to treatment while others may progress rapidly.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516929-31-00Protocol codeLORELYEstimated enrolment50 patientsSponsorHumanitas Mirasole S.p.A.

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