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Study on Brexucabtagene Autoleucel for Adults with Relapsed/Refractory Waldenstrom Macroglobulinemia Using a Drug Combination

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 rare type of blood cancer called Waldenstrom Macroglobulinemia (WM), which is a condition where the body produces too many abnormal white blood cells. The study is testing a treatment called brexucabtagene autoleucel, also known by its code name KTE-X19. This treatment involves using a patient's own immune cells, which are modified in a lab to better fight cancer cells. The purpose of the study is to evaluate how effective this treatment is in patients with WM.

Participants in the study will receive the treatment through an intravenous infusion, which means it is given directly into the bloodstream. The study will also involve other medications, including ibrutinib, a drug that helps block certain proteins that cancer cells need to grow, and cyclophosphamide, a type of chemotherapy. Additionally, supportive medications like mesna to protect the bladder, methylprednisolone and dexamethasone as corticosteroids to reduce inflammation, and fludarabine, another chemotherapy drug, may be used. Some participants may receive a placebo instead of certain medications to compare the effects.

The study will take place over several months, with regular check-ups to monitor the participants' health and the effectiveness of the treatment. The goal is to see how well the treatment works in reducing the cancer and improving the patients' condition. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

The research process

The trial runs in 6 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 a review of medical history and current health status.

    Blood tests and other diagnostic procedures may be performed to ensure all criteria are met for participation.

  2. Step 2

    Leukapheresis

    Leukapheresis is a procedure where blood is drawn to collect white blood cells. This is necessary for the preparation of the treatment.

    During this process, blood is taken from a vein, processed through a machine to separate the white blood cells, and the remaining blood is returned to the body.

  3. Step 3

    Lymphodepletion

    Before receiving the main treatment, a short course of chemotherapy is administered to prepare the body. This is known as lymphodepletion.

    Medications used include cyclophosphamide and fludarabine, given through an intravenous infusion over a few days.

  4. Step 4

    Brexucabtagene autoleucel infusion

    The main treatment involves an infusion of brexucabtagene autoleucel, a type of therapy designed to target specific cancer cells.

    This is administered as an intravenous infusion, and the patient is monitored closely during and after the procedure.

  5. Step 5

    Post-infusion monitoring

    After the infusion, regular monitoring is conducted to assess the response to treatment and manage any side effects.

    Follow-up visits may include physical exams, blood tests, and imaging studies to evaluate the effectiveness of the therapy.

  6. Step 6

    Long-term follow-up

    Long-term follow-up is essential to track the patient's health and the lasting effects of the treatment.

    This phase involves periodic check-ups and assessments over several months or years, as specified by the study protocol.

Who can join the trial?

11 criteria

  • Must be a male or female who is 18 years of age or older.
  • Must have a measurable disease, which means having a certain level of a protein called IgM in the blood that is more than twice the normal limit.
  • Must meet specific requirements about the time between stopping certain treatments and starting the study, except for a drug called ibrutinib, which can be continued until shortly before starting the study treatment.
  • Any side effects from previous treatments must be stable and mild (Grade 1 or lower).
  • Must have an ECOG performance status of 0 or 1, which means being fully active or having some symptoms but still able to carry out light work.
  • Must have adequate blood and organ function.
  • If able to have children and engaging in heterosexual intercourse, must agree to use specified methods of contraception.
  • Must have a confirmed diagnosis of Waldenstrom Macroglobulinemia (WM) according to specific guidelines.
  • Must have relapsed or refractory disease, meaning the disease has returned or not responded after at least two different treatments.
  • Previous treatments must have included a BTK inhibitor, and either chemotherapy or a proteasome inhibitor must have been tried, with the disease either progressing or not responding.
  • Must require treatment as defined by specific recommendations for WM.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have had a severe allergic reaction to similar treatments in the past.
  • Patients who are currently pregnant or breastfeeding.
  • Patients who have an active infection that requires treatment.
  • Patients who have a serious heart condition.
  • Patients who have uncontrolled high blood pressure.
  • Patients who have a history of another serious illness that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have received certain treatments recently that could affect the study results.
  • Patients who are unable to follow the study procedures for any reason.
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Investigated drugs

Brexucabtagene Autoleucel is a type of therapy that uses your own immune cells to fight cancer. In this treatment, some of your white blood cells, called T-cells, are taken from your body and changed in a lab to better recognize and attack cancer cells. After they are modified, these T-cells are put back into your body to help your immune system target and destroy the cancer. This therapy is being tested to see how well it works for people with certain rare types of blood cancer, specifically a condition called Waldenstrom Macroglobulinemia, which affects the bone marrow and blood. The goal is to see if this treatment can help reduce the cancer or make it go away completely.

What is already known about the treatment

Brexucabtagene Autoleucel – This medication is administered through a process called CAR T-cell therapy, where a patient's own T-cells are modified in a lab to better fight cancer cells and then infused back into the patient. It is currently being studied in clinical trials for its effectiveness in treating rare B-cell malignancies, specifically relapsed or refractory Waldenstrom Macroglobulinemia. The main therapeutic indication is for patients whose disease has returned or not responded to previous treatments. At the molecular level, it works by reprogramming the patient's T-cells to recognize and attack cancer cells. It is classified as a type of immunotherapy, which is a treatment that uses the body's immune system to fight cancer.

Investigated diseases

Waldenstrom Macroglobulinemia – Waldenstrom Macroglobulinemia is a rare type of non-Hodgkin lymphoma characterized by an excess of abnormal white blood cells in the bone marrow. These cells produce large amounts of a protein called monoclonal immunoglobulin M (IgM), which can lead to thickening of the blood. The disease progresses slowly, and symptoms may include fatigue, bleeding, and neurological issues due to the thickened blood. Over time, the accumulation of these abnormal cells can interfere with normal blood cell production, leading to anemia and other blood-related issues. The progression of the disease can vary significantly among individuals, with some experiencing more rapid changes than others.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501259-10-00Protocol codeKT-US-568-0138-AEstimated enrolment62 patientsSponsorKite Pharma Inc.

sourced from the EU Clinical Trials Register and site verification

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