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Study on the Effectiveness and Safety of Sonrotoclax and Zanubrutinib for Adults with Relapsed or Refractory Mantle Cell 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 type of cancer called mantle cell lymphoma, specifically in patients whose disease has returned or has not responded to previous treatments. The study will test the effectiveness and safety of a new treatment combination. The treatment involves two medications: Sonrotoclax and Zanubrutinib. Sonrotoclax is a new drug being tested, while Zanubrutinib is already used in treating certain types of cancer. The study will compare the effects of taking Sonrotoclax and Zanubrutinib together against taking a placebo with Zanubrutinib.

The purpose of the study is to see if the combination of Sonrotoclax and Zanubrutinib works better than the current standard treatment. Participants in the study will be randomly assigned to receive either the new combination or the standard treatment. The study will be conducted in a way that neither the participants nor the researchers know who is receiving which treatment, to ensure unbiased results. The study will monitor how long patients live without their disease getting worse, as well as other health outcomes.

Throughout the study, participants will take the medications orally, meaning they will swallow them. The study will last for a period of time, during which participants will have regular check-ups to monitor their health and the effects of the treatment. The goal is to gather information that could lead to better treatment options for people with relapsed or refractory mantle cell lymphoma in the future.

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 randomly assigned to one of two groups. One group will receive the combination of sonrotoclax and zanubrutinib, while the other group will receive a placebo and zanubrutinib. This process is called randomization and ensures that the study results are unbiased.

  2. Step 2

    Medication administration

    If you are in the group receiving sonrotoclax and zanubrutinib, you will take these medications orally. Zanubrutinib is provided in capsule form, and sonrotoclax is provided in film-coated tablet form. The exact dosage and frequency will be explained to you by the study team.

    If you are in the group receiving the placebo and zanubrutinib, you will take the placebo in place of sonrotoclax, along with zanubrutinib capsules. The placebo is also provided in film-coated tablet form.

  3. Step 3

    Regular check-ups

    Throughout the study, you will have regular check-ups to monitor your health and the effects of the treatment. These check-ups will include physical examinations, blood tests, and other necessary assessments to ensure your safety and to evaluate the effectiveness of the treatment.

  4. Step 4

    Questionnaires

    You will be asked to complete questionnaires about your symptoms, physical condition, and overall quality of life. These questionnaires are designed to gather information on how the treatment affects your daily life and well-being.

  5. Step 5

    End of treatment

    The treatment period will continue until the study ends or until it is determined that the treatment is no longer beneficial for you. At the end of the treatment, you will have a final assessment to evaluate your overall health and the outcomes of the study.

Who can join the trial?

8 criteria

  • Must have a confirmed diagnosis of mantle cell lymphoma (MCL), which is a type of cancer, based on specific medical classifications.
  • Must have received 1 to 5 previous treatments for MCL, including a treatment that uses an anti-CD20 monoclonal antibody, which is a type of targeted therapy for cancer.
  • The disease must have returned or not responded to the last treatment.
  • Must have a measurable disease, meaning at least one lymph node that is larger than 1.5 cm or one area outside the lymph nodes that is larger than 1 cm.
  • 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. A score of 0 means fully active, and 2 means capable of all self-care but unable to carry out any work activities.
  • Must have adequate organ function, meaning the organs are working well enough to participate in the study.
  • Open to both male and female participants.
  • Participants must be adults.

Who cannot join the trial?

8 criteria

  • Patients who do not have relapsed or refractory mantle cell lymphoma (R/R MCL) cannot participate. This means the study is only for those whose specific type of lymphoma has returned or did not respond to treatment.
  • Patients who are not within the specified age range cannot participate. The study is for adults only.
  • Patients who are not willing or able to follow the study procedures cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have allergies or adverse reactions to the study drugs cannot participate.
  • Patients who have certain infections or diseases that could affect the study results cannot participate.
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Investigated drugs

  • Sonrotoclax

    is a medication being studied for its potential to help treat a type of cancer called mantle cell lymphoma, which is a cancer of the lymphatic system. In this clinical trial, researchers are testing whether adding sonrotoclax to another medication can help stop the cancer from growing or spreading. Sonrotoclax works by targeting and blocking certain proteins in cancer cells that help them survive, which may lead to the death of these cancer cells.

  • Zanubrutinib

    is a medication used to treat certain types of blood cancers, including mantle cell lymphoma. It works by blocking a specific protein in the cancer cells that helps them grow and divide. By inhibiting this protein, zanubrutinib can slow down or stop the growth of cancer cells. In this trial, zanubrutinib is being used in combination with another medication to see if this combination is more effective in treating the cancer than using zanubrutinib alone.

What is already known about the treatment

  • Sonrotoclax

    Sonrotoclax is administered orally in the form of a tablet and is currently being studied in clinical trials for its effectiveness in treating relapsed or refractory mantle cell lymphoma (R/R MCL). It is not yet widely used in medicine, as it is still under investigation. The main therapeutic indication for sonrotoclax is to help improve progression-free survival in patients with this type of lymphoma. At the molecular level, sonrotoclax works by inhibiting certain proteins that help cancer cells survive, thereby promoting their death. It is classified pharmacologically as a BCL-2 inhibitor, which targets proteins involved in cell survival.

  • Zanubrutinib

    Zanubrutinib is also taken orally as a capsule and is currently approved for use in certain types of blood cancers, including mantle cell lymphoma. In the context of this clinical trial, it is being used in combination with sonrotoclax to assess its effectiveness in improving patient outcomes. Zanubrutinib is primarily indicated for treating relapsed or refractory mantle cell lymphoma. It works by blocking a protein called Bruton's tyrosine kinase (BTK), which is involved in the growth and survival of cancer cells. Pharmacologically, zanubrutinib is classified as a BTK inhibitor.

Investigated diseases

Mantle Cell Lymphoma – Mantle Cell Lymphoma is a type of non-Hodgkin lymphoma that originates from B-cells, a type of white blood cell. It typically begins in the outer edge of a lymph node called the mantle zone. The disease often progresses to involve other lymph nodes, bone marrow, and sometimes the spleen and gastrointestinal tract. As it advances, it can lead to symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The progression of the disease can vary, with some cases advancing slowly while others progress more rapidly. It is considered a rare form of lymphoma.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515593-27-00Protocol codeBGB-11417-302Estimated enrolment300 patientsSponsorBeOne Medicines AG

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