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Study of Brexucabtagene Autoleucel in Patients with Relapsed or Refractory Mantle 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 Relapsed/Refractory Mantle Cell Lymphoma, which is a form of non-Hodgkin's lymphoma. The study is evaluating a treatment known as Brexucabtagene Autoleucel, also referred to by its code name KTE-X19. This treatment is a type of cell therapy that involves modifying a patient's own T cells, which are a part of the immune system, to better recognize and attack cancer cells.

The purpose of the study is to assess how effective this treatment is in patients whose cancer has returned or has not responded to previous treatments. Participants in the study will receive the treatment through an infusion, which is a method of delivering medication directly into the bloodstream. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment.

The study will take place over a period of time, during which participants will be closely monitored by healthcare professionals. This monitoring will include regular check-ups and tests to evaluate the response to the treatment and to ensure the safety of the participants. The study aims to provide valuable information on the potential benefits and risks of using Brexucabtagene Autoleucel for treating Relapsed/Refractory Mantle Cell 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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes checking medical history, current health status, and previous treatments for mantle cell lymphoma.

    Blood tests and imaging scans are performed to ensure all criteria are met, such as having at least one measurable lesion and adequate organ function.

  2. Step 2

    Pre-treatment phase

    Before starting the main treatment, a series of medications are administered to prepare the body. This includes cyclophosphamide and fludarabine phosphate, given through an intravenous infusion to help the body accept the main treatment.

    These medications are typically administered over a few days, with specific dosages determined by the healthcare team.

  3. Step 3

    Main treatment

    The main treatment involves receiving brexucabtagene autoleucel through an intravenous infusion. This is a specialized therapy designed to target and treat mantle cell lymphoma.

    The infusion is monitored closely by healthcare professionals to manage any immediate reactions or side effects.

  4. Step 4

    Post-treatment monitoring

    After the main treatment, regular follow-up visits are scheduled to monitor health and response to the therapy. This includes physical exams, blood tests, and imaging scans.

    Additional medications such as tocilizumab and diphenhydramine hydrochloride may be provided to manage side effects and support recovery.

  5. Step 5

    Long-term follow-up

    Long-term follow-up is essential to evaluate the effectiveness of the treatment and monitor for any late side effects. This phase involves periodic check-ups and assessments over several months or years.

    The healthcare team will provide guidance on lifestyle and health management during this period.

Who can join the trial?

11 criteria

  • Have been diagnosed with Relapsed/Refractory Mantle Cell Lymphoma (a type of blood cancer that has returned or did not respond to treatment).
  • Have received up to 5 previous treatments for Mantle Cell Lymphoma. These treatments must have included:
    • Chemotherapy containing anthracycline or bendamustine (types of cancer drugs).
    • Therapy with an anti-CD20 monoclonal antibody (a type of drug that targets specific cells).
    • Must not have received previous treatment with a BTKi (a type of drug used in cancer treatment).
    • Have at least one measurable lesion (an area of cancer that can be measured).
    • Have a platelet count of at least 75,000 per microliter of blood (platelets are cells that help with blood clotting).
    • Have a creatinine clearance of at least 60 cc/min (a measure of kidney function).
    • Have a cardiac ejection fraction of at least 50% (a measure of heart function), no fluid around the heart as shown by an echocardiogram (ECHO) or multigated acquisition (MUGA) scan, and no significant findings on an electrocardiogram (ECG) (a test that checks heart rhythm).
    • Have a baseline oxygen saturation greater than 92% on room air (a measure of how much oxygen is in the blood).
    • Be within the age range of adults (18 years and older).
    • Both male and female participants are eligible.

Who cannot join the trial?

4 criteria

  • Patients who have not been diagnosed with Relapsed/Refractory Mantle Cell Lymphoma cannot participate. This is a type of cancer that affects the lymph nodes.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study.
  • Patients who are not part of the specified clinical trial groups cannot participate. These groups are usually defined by the study based on certain characteristics.
  • Patients who are considered part of a vulnerable population may not be eligible. This includes individuals who might be at higher risk due to certain conditions or circumstances.
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Investigated drugs

KTE-X19 is a type of therapy that uses your own immune cells to fight cancer. In this treatment, some of your white blood cells, which are part of your immune system, are taken from your body. These cells are then changed in a laboratory to help them recognize and attack cancer cells more effectively. After this process, the modified cells are put back into your body to help fight the cancer. This therapy is being tested to see how well it works for people with a type of cancer called mantle cell lymphoma that has come back or has not responded to other treatments.

What is already known about the treatment

KTE-X19 – KTE-X19 is administered as an infusion directly into the bloodstream, a method known as intravenous administration. It is currently being studied in clinical trials for its effectiveness in treating a type of cancer called relapsed or refractory mantle cell lymphoma, which is a condition where the cancer returns or does not respond to treatment. The medication works by modifying the patient's own immune cells to better recognize and attack cancer cells, essentially boosting the body's natural defenses against the disease. KTE-X19 falls under the category of immunotherapy, which is a type of treatment that uses the immune system to fight cancer.

Investigated diseases

Mantle Cell Lymphoma – Mantle Cell Lymphoma is a type of non-Hodgkin lymphoma that originates from B-cells, which are a type of white blood cell. It typically begins in the lymph nodes but can spread to other tissues such as the bone marrow, spleen, and gastrointestinal tract. The disease is characterized by the overproduction of abnormal B-cells, which can lead to the enlargement of lymph nodes and other organs. As the disease progresses, it can cause symptoms such as fatigue, fever, night sweats, and weight loss. The progression of Mantle Cell Lymphoma can vary, with some cases advancing more rapidly than others. The disease is often diagnosed at an advanced stage due to its subtle early symptoms.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506641-35-00Protocol codeKTE-C19-102Estimated enrolment183 patientsSponsorKite Pharma Inc.

sourced from the EU Clinical Trials Register and site verification

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