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Study on Brexucabtagene Autoleucel for Adults with Relapsed/Refractory Richter Transformation (RT)

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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 Richter Transformation, which occurs when chronic lymphocytic leukemia (CLL) transforms into a more aggressive form known as diffuse large B-cell lymphoma (DLBCL). The study is investigating the effectiveness and safety of a treatment called brexucabtagene autoleucel, a type of cell therapy that uses genetically modified T cells to target and destroy cancer cells. This treatment is specifically designed for adults who have experienced a relapse or whose disease has not responded to previous treatments.

The purpose of the study is to evaluate how well brexucabtagene autoleucel works in treating patients with Richter Transformation. Participants in the study will receive the treatment through an intravenous infusion, which means the medication is delivered directly into the bloodstream. The study will monitor the participants' response to the treatment, including whether the cancer shrinks or disappears, and how long the response lasts. The study will also assess the overall survival of participants and the time it takes for the disease to progress or for the next treatment to be needed.

In addition to brexucabtagene autoleucel, the study may involve other medications to support the treatment process. These include carboplatin, mesna, ifosfamide, vincristine, etoposide, gemcitabine, oxaliplatin, methylprednisolone, rituximab, alpelisib, and ibrutinib. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the treatment. The study aims to provide valuable information on the potential benefits and risks of using brexucabtagene autoleucel for treating 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

    Enrollment and initial assessment

    Upon joining the study, you will undergo an initial assessment to confirm eligibility. This includes verifying your age, medical history, and current health status. You must be 18 years or older and have a confirmed diagnosis of relapsed or refractory Richter Transformation (RT).

    You will need to have at least one measurable lesion and meet specific health criteria, such as adequate organ function and a performance status score of 0 or 1, which indicates your ability to carry out daily activities.

  2. Step 2

    Treatment preparation

    Before starting the main treatment, you may receive medications to prepare your body. This could include drugs like cyclophosphamide and fludarabine, administered through an intravenous infusion. These medications help prepare your immune system for the main treatment.

  3. Step 3

    Main treatment

    The main treatment involves receiving brexucabtagene autoleucel, a specialized therapy designed to target cancer cells. This is administered as an intravenous infusion. The exact dosage and frequency will be determined by the study team based on your specific condition.

  4. Step 4

    Monitoring and follow-up

    After receiving the main treatment, you will be closely monitored for any side effects and to assess the treatment's effectiveness. This involves regular check-ups and tests to track your response to the therapy.

    The study aims to evaluate the response rate, which is the proportion of patients who experience a significant reduction in cancer symptoms. Your progress will be assessed using established medical criteria.

  5. Step 5

    Completion and final assessment

    At the end of the study period, a final assessment will be conducted to evaluate the overall effectiveness of the treatment and any long-term effects. This will include a comprehensive review of your health status and any changes in your condition.

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 specific medical guidelines. Lesions that were treated with radiation can be counted only if they have grown again after treatment.
  • Any side effects from previous treatments must be stable and have improved to a mild level.
  • 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 specific methods of birth control.
  • Must have a confirmed diagnosis of CLL (a type of blood cancer) with a specific transformation to another type called DLBCL.
  • Must have a disease that has returned or not responded after one line of therapy, defined as either:
  • Refractory disease: The disease did not improve or only stayed the same after the first treatment.
  • Relapsed disease: The disease was in complete remission after the first treatment but has returned, confirmed by a biopsy.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer that is not related to Richter Transformation (RT) cannot participate.
  • Patients who have had a severe allergic reaction to similar treatments in the past are not eligible.
  • Patients with uncontrolled infections, meaning infections that are not being managed well with treatment, cannot join the study.
  • Patients who are pregnant or breastfeeding are not allowed to participate.
  • Patients with significant heart problems, such as heart failure or recent heart attacks, are excluded.
  • Patients with active hepatitis B or C, or HIV, which are viral infections, cannot take part in the study.
  • Patients who have had another cancer treatment within a certain period before the study starts are not eligible.
  • Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate are excluded.
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Investigated drugs

Brexucabtagene Autoleucel is a type of therapy used in this clinical trial. It is a form of treatment known as CAR T-cell therapy. This therapy involves taking some of your own immune cells, called T-cells, and modifying them in a laboratory to better recognize and attack cancer cells. Once these modified cells are ready, they are infused back into your body to help fight the cancer. In this trial, the focus is on using this therapy to treat a specific type of cancer called Richter Transformation, which is a rare and aggressive form of B-cell malignancy. The goal is to see how well this therapy works in reducing or eliminating the cancer in patients who have this condition.

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 and reintroduced into their body to fight cancer. It is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory Richter Transformation, a type of B-cell malignancy. The main therapeutic indication is for patients with this specific type of cancer who have not responded to other treatments. At the molecular level, it works by targeting and destroying cancerous B-cells, helping the immune system to better fight the disease. It is classified as a type of immunotherapy, specifically a CAR T-cell therapy.

Investigated diseases

Richter Transformation – Richter Transformation is a condition where chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) transforms into a more aggressive type of lymphoma, most commonly diffuse large B-cell lymphoma (DLBCL). This transformation leads to a rapid progression of the disease, characterized by a sudden increase in lymph node size, worsening of symptoms, and a more aggressive clinical course. The disease progression involves the accumulation of large, abnormal B-cells, which can spread to other parts of the body, including the liver, spleen, and bone marrow. Patients may experience symptoms such as fever, night sweats, weight loss, and fatigue. The transformation is often identified through a biopsy of the affected lymph nodes or other tissues. The condition is considered rare and represents a significant change in the behavior of the underlying CLL or SLL.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501260-18-00Protocol codeKT-US-568-0138-BEstimated enrolment60 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).