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Study on Brexucabtagene Autoleucel for Adults with Relapsed or Refractory Burkitt Lymphoma

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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 cancer called Burkitt Lymphoma, which is a form of B-cell malignancy. The treatment being tested is called brexucabtagene autoleucel, also known by its code name KTE-X19. This treatment is a type of cell therapy that involves modifying a patient's own T cells to help them fight cancer. The purpose of the study is to evaluate how effective this treatment is in patients with relapsed or refractory Burkitt Lymphoma, meaning the cancer has returned or did not respond to previous treatments.

Participants in the study will receive the treatment through an intravenous infusion, which means it is delivered directly into the bloodstream. The study will monitor the response of the cancer to the treatment, looking for signs of improvement such as a reduction in the size of the cancer or complete disappearance. The study will also track how long any positive effects last and the overall survival of participants. The trial is designed to gather information over a period of time to understand the benefits and any potential risks associated with the treatment.

In addition to the main treatment, other medications may be used to support the participants during the trial. These include dexamethasone, a corticosteroid that helps reduce inflammation, and mesna, which is used to protect the bladder from harmful effects of certain chemotherapy drugs. The study aims to provide valuable insights into the potential of brexucabtagene autoleucel as a treatment option for those with Burkitt Lymphoma, offering hope for improved outcomes in this challenging condition.

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 for a measurable lesion and ensuring recovery from previous treatments.

    The assessment also involves evaluating overall health, including blood tests and organ function checks.

  2. Step 2

    Treatment preparation

    Once eligibility is confirmed, preparation for treatment begins. This may involve additional tests to ensure readiness for the treatment process.

    Participants are informed about the treatment plan, including potential side effects and necessary precautions.

  3. Step 3

    Treatment administration

    The main treatment involves the administration of brexucabtagene autoleucel through an intravenous infusion. This is a specialized procedure where the treatment is delivered directly into the bloodstream.

    The infusion is monitored closely by medical professionals to ensure safety and effectiveness.

  4. Step 4

    Monitoring and follow-up

    After the treatment, regular follow-up appointments are scheduled to monitor the response to the treatment. This includes physical examinations and imaging tests.

    The response to the treatment is assessed using the Lugano Classification, which helps determine the effectiveness of the therapy.

  5. Step 5

    Evaluation of outcomes

    The primary outcome measured is the response rate, which indicates how well the treatment is working. This is determined by central assessment.

    Secondary outcomes include the duration of response, overall survival, and progression-free survival, which are evaluated over time.

Who can join the trial?

10 criteria

  • Must be a male or female who is 18 years of age or older.
  • Must have at least one measurable lesion (an area of abnormal tissue) based on the Lugano Classification. Lesions that were treated with radiation can be measured only if they have grown again after treatment.
  • Any side effects from previous treatments must be stable and have improved to a mild level (Grade 1 or lower).
  • Must have an ECOG performance status score 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 (birth control).
  • Must have a confirmed diagnosis of mature B-cell non-Hodgkin lymphoma, specifically Burkitt lymphoma or leukemia.
  • Must have relapsed or refractory disease after first-line chemoimmunotherapy, which means:
  • Refractory disease: The disease did not improve or only stayed the same after first-line therapy. Individuals who could not tolerate first-line therapy are not eligible.
  • Relapsed disease: The disease returned after a complete remission (no signs of disease) following first-line therapy, confirmed by a biopsy.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer than **Relapsed/Refractory Burkitt Lymphoma (BL)** cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial group cannot participate.
  • Patients who are not male or female cannot participate.
  • Patients who are considered part of a vulnerable population cannot participate.
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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 modified in a laboratory to better recognize and attack cancer cells. Once these cells are ready, they 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 a specific type of cancer called Burkitt Lymphoma, which is a rare form of B-cell malignancy.

What is already known about the treatment

Brexucabtagene Autoleucel – This medication is administered through an infusion, which means it is given directly into the bloodstream. It is currently being studied in clinical trials for its effectiveness in treating rare B-cell malignancies, specifically relapsed or refractory Burkitt Lymphoma. The main therapeutic use of brexucabtagene autoleucel is to help the immune system target and destroy cancer cells. At the molecular level, it works by modifying a patient's own T-cells to better recognize and attack cancer cells. It is classified as a type of CAR T-cell therapy, which is a form of immunotherapy.

Investigated diseases

Relapsed/Refractory Burkitt Lymphoma – Burkitt Lymphoma is a type of non-Hodgkin lymphoma that originates from B-cells, which are a type of white blood cell. It is characterized by the rapid growth of tumors in the lymph nodes, spleen, liver, and other organs. In its relapsed or refractory form, the disease has either returned after treatment or has not responded to initial therapy. The progression involves aggressive and fast-growing tumors, often leading to symptoms such as swelling in the abdomen, night sweats, and unexplained weight loss. The disease can spread quickly to other parts of the body, including the central nervous system. It requires close monitoring due to its rapid progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501261-46-00Protocol codeKT-US-568-0138-CEstimated enrolment33 patientsSponsorKite Pharma Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).