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Study of Mosunetuzumab and Polatuzumab Vedotin Combination Treatment in Patients with B-Cell Non-Hodgkin 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 studies the combination of two medications - mosunetuzumab and polatuzumab vedotin - in patients with B-cell non-Hodgkin lymphoma. This type of lymphoma is a cancer that starts in white blood cells called B cells. The study includes patients whose disease has returned or did not respond to previous treatments.

The medications being tested are both types of targeted therapies. Mosunetuzumab is a specially designed antibody that helps the immune system recognize and attack cancer cells. Polatuzumab vedotin is a medication that combines an antibody with a substance that kills cancer cells. The study will test these medications given together through intravenous infusion or as an injection under the skin.

The study will check if this combination of medications is safe to use and how well it works in treating the lymphoma. Researchers will monitor patients for side effects and measure if the cancer responds to the treatment. The study will also look at how long any improvements last and how the medications move through the body. Additional medications may be given to help manage side effects, including prednisone, dexamethasone, paracetamol, and other supportive care medicines.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial Treatment Phase

    You will receive a combination of two main medications through intravenous infusion (delivered directly into your vein):

    - Mosunetuzumab

    - Polatuzumab vedotin

    Before the main treatment, you will receive preparatory medications to help manage potential reactions:

    - Paracetamol (oral tablet)

    - Diphenhydramine (antihistamine medication through infusion)

    - Methylprednisolone (steroid medication through infusion)

  2. Step 2

    Monitoring Phase

    Regular assessments will track your response to treatment including:

    - Blood tests to check laboratory values

    - Vital signs monitoring

    - Measurement of tumor response using imaging scans

  3. Step 3

    Additional Support Medications

    You may receive additional medications as needed:

    - Rituximab (through infusion)

    - Tocilizumab (through infusion)

    - Allopurinol (oral medication)

    These medications help manage side effects and support your treatment

  4. Step 4

    Follow-up Assessments

    Regular evaluation of your condition will continue to track:

    - How well the treatment is working

    - Any side effects that may occur

    - Your overall health status

    The study is expected to continue until July 2025

Who can join the trial?

6 criteria

  • Must be 18 years or older when signing the consent form
  • Must have confirmed relapsed or refractory (returning or not responding to treatment) follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), or mantle cell lymphoma (MCL)
  • For patients with DLBCL or FL: Must have received at least one previous treatment that included therapy targeting CD20 (a protein found on certain blood cells)
  • For patients with MCL: Must have received at least two previous treatments including: - Treatment targeting CD20 - A BTK inhibitor (medication that blocks a specific protein) - Either anthracycline or bendamustine (types of chemotherapy drugs)
  • Must have an ECOG Performance Status of 0, 1, or 2 (a measure of daily living abilities, where 0 means fully active and 2 means able to do light activities)
  • Must have measurable disease with at least one of these: - A lymph node larger than 1.5 centimeters - A tumor outside lymph nodes larger than 1.0 centimeter

Who cannot join the trial?

13 criteria

  • History of severe allergic reactions or anaphylaxis (serious allergic reaction)
  • Active infections requiring treatment, including hepatitis B, hepatitis C, or HIV
  • Presence of active central nervous system lymphoma (cancer affecting brain or spinal cord)
  • Prior treatment with CAR T-cell therapy (a type of cell-based cancer treatment) within 3 months before starting the study
  • Significant heart problems, including heart failure or uncontrolled heart rhythm disorders
  • Severe liver problems or abnormal liver function tests
  • Severe kidney problems or abnormal kidney function
  • History of other cancers within the past 2 years (except for successfully treated skin cancers or early-stage cancers)
  • Pregnancy or breastfeeding
  • Participation in another clinical trial within 28 days before starting this study
  • Inability to comply with study procedures or follow-up visits
  • Major surgery within 4 weeks before starting the study
  • Serious medical conditions that could interfere with study participation
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Investigated drugs

Mosunetuzumab is a medication designed to target and treat B-cell lymphomas. It works by helping the body's immune system recognize and attack cancer cells, specifically in patients with non-Hodgkin lymphoma. This medication can be given either through an intravenous (IV) infusion directly into the vein or as a subcutaneous (under the skin) injection. Polatuzumab vedotin is an antibody-drug conjugate that specifically targets B-cells in non-Hodgkin lymphoma. It works by delivering a cancer-killing substance directly to cancer cells. This targeted approach helps to destroy cancer cells while limiting damage to healthy cells. The medication is given through an intravenous (IV) infusion. These medications are being studied in combination to treat patients with different types of B-cell non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL), particularly in cases where previous treatments have not worked or the disease has returned.

What is already known about the treatment

  • Mosunetuzumab

    A novel bispecific antibody administered through intravenous (IV) or subcutaneous (SC) injection, developed for treating B-cell non-Hodgkin lymphoma. This medication works by simultaneously binding to CD20 on B-cells and CD3 on T-cells, redirecting T-cells to eliminate malignant B-cells. Currently undergoing Phase Ib/II clinical trials, it represents a promising therapeutic approach for patients with relapsed or refractory lymphomas, particularly diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma.

  • Polatuzumab vedotin

    An antibody-drug conjugate administered intravenously, combining an anti-CD79b antibody with a potent anti-microtubule agent. This medication specifically targets B-cells in non-Hodgkin lymphoma, delivering its cytotoxic component directly to cancer cells. It has shown significant promise in clinical trials for treating relapsed or refractory B-cell lymphomas, particularly when used in combination therapy, and works by disrupting the cellular division of cancer cells while minimizing damage to healthy tissue.

Investigated diseases

  • B-cell non-Hodgkin lymphoma

    A type of blood cancer that develops in the lymphatic system from B-cells, which are white blood cells that help fight infections. The disease begins when healthy B-cells transform into abnormal cells that grow and divide uncontrollably. These abnormal cells can develop in any part of the body where lymph tissue is found, including lymph nodes, spleen, and bone marrow. The condition can be either aggressive (fast-growing) or indolent (slow-growing). The disease can cause enlarged lymph nodes, fever, night sweats, and unexplained weight loss.

  • Diffuse Large B-cell Lymphoma (DLBCL)

    An aggressive form of B-cell non-Hodgkin lymphoma that affects the B-cells in the lymphatic system. The disease is characterized by the rapid growth of abnormally large B-cells that spread throughout lymph nodes and can affect other organs. It typically presents as quickly growing masses in lymph node areas.

  • Follicular Lymphoma (FL)

    A slow-growing type of B-cell non-Hodgkin lymphoma that develops when B-cells become abnormal and collect in lymph nodes. The disease is characterized by the circular arrangement of abnormal B-cells in the lymph nodes, forming follicles. It typically progresses slowly and can affect multiple lymph node sites.

  • Mantle Cell Lymphoma (MCL)

    A rare type of B-cell non-Hodgkin lymphoma that starts in the outer edge of lymph nodes called the mantle zone. The disease develops when B-cells in the mantle zone become abnormal and multiply uncontrollably. It can spread to other parts of the body including the bone marrow, blood, and other organs.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-506986-74-00Protocol codeGO40516Estimated enrolment235 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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