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Study on the Safety and Effectiveness of Mosunetuzumab and Atezolizumab for Patients with Relapsed or Refractory Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia

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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 the effects of a treatment for certain types of blood cancers, specifically Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia. The treatment being tested is called Mosunetuzumab, which is a type of protein used to target cancer cells. In some parts of the study, Mosunetuzumab is used alone, while in others, it is combined with another medication called Atezolizumab. The purpose of the study is to evaluate the safety and effectiveness of these treatments in patients whose cancer has returned or has not responded to previous treatments.

Participants in the study will receive Mosunetuzumab either as a solution for injection under the skin or as a solution for infusion into a vein. The study will also explore how the body processes the medication, which is known as pharmacokinetics. Some participants will receive a combination of Mosunetuzumab and Atezolizumab, which is also given as a solution for infusion. The study will monitor the participants over time to assess how well the treatment works and to identify any side effects or adverse reactions.

The trial aims to determine the best dose and schedule for using Mosunetuzumab alone or with Atezolizumab. It will also compare the effectiveness of the treatment when given by different methods, such as injection versus infusion. The study is expected to continue until November 2025, and it will provide valuable information on the potential benefits and risks of these treatments for patients with Non-Hodgkin's Lymphoma and Chronic Lymphocytic Leukemia.

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 treatment phase

    The trial begins with the administration of mosunetuzumab as a single agent. This medication is given through a subcutaneous injection, which means it is injected under the skin.

    The dosage and frequency of administration will be determined by the study team based on individual patient needs and responses.

  2. Step 2

    Combination treatment phase

    In this phase, mosunetuzumab is combined with atezolizumab. Atezolizumab is administered through an intravenous infusion, meaning it is delivered directly into the bloodstream through a vein.

    The combination aims to evaluate the safety and effectiveness of the two medications together.

  3. Step 3

    Monitoring and assessment

    Throughout the trial, regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes checking for any side effects and measuring the response to the treatment.

    Blood tests and imaging studies may be performed to evaluate the progress of the treatment.

  4. Step 4

    Dose adjustment

    Based on the patient's response and any side effects experienced, the dosage of mosunetuzumab and atezolizumab may be adjusted.

    The goal is to find the most effective dose with the fewest side effects.

  5. Step 5

    Completion of treatment

    The treatment phase concludes once the study objectives are met or if it is determined that the treatment is not effective for the patient.

    Final assessments are conducted to evaluate the overall response to the treatment.

  6. Step 6

    Follow-up

    After completing the treatment, follow-up visits are scheduled to monitor the patient's health and any long-term effects of the treatment.

    These visits help ensure the patient's well-being and gather additional data on the treatment's impact.

Who can join the trial?

5 criteria

  • Patients must agree to provide tumor samples. For those with non-Hodgkin's lymphoma (NHL) and more than one measurable tumor, a biopsy from a safe site is needed. For chronic lymphocytic leukemia (CLL) patients, a bone marrow biopsy and blood sample are required.
  • Patients should have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work. They should also have a life expectancy of at least 12 weeks.
  • Patients must have a confirmed diagnosis of relapsed or refractory NHL or CLL that is expected to show the presence of a specific protein called **CD20**. There should be no other available treatment that is expected to improve their survival.
  • For NHL patients only, there must be at least one measurable tumor that is larger than 1.5 cm for nodal tumors or larger than 1.0 cm for tumors outside the lymph nodes, as seen on a CT or MRI scan.
  • Patients must have adequate liver, blood, and kidney function.

Who cannot join the trial?

6 criteria

  • Patients who have a different type of cancer than the ones being studied, which are **B-Cell Malignancies**.
  • Patients who have not experienced a return or worsening of their **non-Hodgkin’s lymphoma (NHL)** or **chronic lymphocytic leukemia (CLL)** after treatment.
  • Patients who have not received at least two previous treatments for their condition.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to safely tolerate the study medications.
  • Patients who are part of a vulnerable population that the study is not designed to include.
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Investigated drugs

  • Mosunetuzumab

    is a medication being studied for its potential to treat patients with relapsed or refractory B-cell non-Hodgkin's lymphoma and chronic lymphocytic leukemia. It is being tested both as a single agent and in combination with another medication. The trial aims to evaluate its safety, how well it is tolerated by patients, and how the body processes the drug. Researchers are also trying to determine the most effective dose and schedule for using mosunetuzumab.

  • Atezolizumab

    is another medication involved in this trial. It is being combined with mosunetuzumab to see if the combination is more effective in treating the same types of cancer. Atezolizumab is known to help the immune system attack cancer cells, and the trial is assessing whether this combination can improve treatment outcomes for patients with relapsed or refractory non-Hodgkin's lymphoma and chronic lymphocytic leukemia.

What is already known about the treatment

Mosunetuzumab – This medication is administered either intravenously or subcutaneously and is currently being studied in clinical trials for its safety and effectiveness in treating B-cell malignancies, specifically relapsed or refractory non-Hodgkin’s lymphoma and chronic lymphocytic leukemia. It is a promising treatment in the field of oncology, with ongoing research to determine the optimal dosing and potential side effects. Mosunetuzumab works by engaging the immune system to target and destroy cancer cells, specifically by binding to CD20 on B-cells and CD3 on T-cells, facilitating the immune response against the cancer. It is classified as a bispecific monoclonal antibody, a type of targeted cancer therapy.

Investigated diseases

  • Non-Hodgkin's Lymphoma

    This is a type of cancer that originates in the lymphatic system, which is part of the body's immune system. It involves the abnormal growth of lymphocytes, a type of white blood cell, which can form tumors throughout the body. The disease can progress at varying rates, with some forms being slow-growing and others more aggressive. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The progression of the disease can lead to the spread of cancerous cells to other parts of the body. The exact cause of non-Hodgkin's lymphoma is not well understood, but it involves genetic mutations in the lymphocytes.

  • Chronic Lymphocytic Leukemia

    This is a type of cancer that affects the blood and bone marrow, characterized by the overproduction of abnormal lymphocytes. It typically progresses slowly and may not cause symptoms for years. As the disease advances, it can lead to symptoms such as fatigue, swollen lymph nodes, and frequent infections. The accumulation of these abnormal cells can interfere with the production of normal blood cells, leading to anemia and other complications. The cause of chronic lymphocytic leukemia is not fully known, but it involves genetic changes in the lymphocytes. The disease is more common in older adults and may be detected during routine blood tests.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-506820-10-00Protocol codeGO29781Estimated enrolment713 patientsSponsorGenentech Inc.

sourced from the EU Clinical Trials Register and site verification

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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).