Mosunetuzumab +/− Polatuzumab Vedotin and Obinutuzumab for Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of combining three drugs—mosunetuzumab, obinutuzumab, and polatuzumab vedotin—for treating indolent B-cell non-Hodgkin lymphoma. These drugs specifically target cancer cells, potentially stopping their growth and spread. The trial consists of two parts: some participants receive all three drugs, while others might receive only two. Individuals with indolent B-cell non-Hodgkin lymphoma who have not undergone previous systemic treatment may be suitable candidates, especially if they experience symptoms like discomfort or certain health-affecting conditions. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you are on medications that affect CYP3A4, you will need to stop them for a certain period before starting Part B of the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that mosunetuzumab is generally well-tolerated by patients with relapsed or refractory non-Hodgkin lymphoma. A recent study found infections to be the most common side effect, affecting about 47% of patients, though these were mostly mild, like common colds.
For obinutuzumab, safety studies have identified some serious side effects, such as reactions during drug administration, rapid cancer cell breakdown, and low platelet counts. These can be serious, so doctors take steps to manage them.
Polatuzumab vedotin has also been studied, with about 64% of patients experiencing serious side effects. The main concerns were blood-related issues, such as low blood cell counts. Fatal reactions were rare but occurred in about 7% of cases.
This trial is in phase 2, indicating that researchers already have some safety information. However, they are still learning how these treatments work together.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments because they offer new hope for lymphoma patients by targeting cancer cells in innovative ways. Mosunetuzumab is engineered to recruit T-cells to attack lymphoma cells, offering a novel mechanism compared to traditional therapies like chemotherapy. Polatuzumab Vedotin delivers a potent anti-cancer agent directly to cancer cells, minimizing damage to normal cells. Obinutuzumab enhances the immune system's ability to fight cancer, potentially leading to better outcomes. This combination aims to provide more effective and targeted treatment with potentially fewer side effects.
What evidence suggests that this trial's treatments could be effective for indolent B-cell non-Hodgkin lymphoma?
Research shows that mosunetuzumab holds promise for treating a slow-growing type of B-cell non-Hodgkin lymphoma. Studies have found that 80% of patients responded to the treatment, with 60% experiencing their cancer shrinking or disappearing completely. In this trial, some participants will receive mosunetuzumab alone, while others will receive a combination of mosunetuzumab with polatuzumab vedotin and obinutuzumab. Combining mosunetuzumab with polatuzumab vedotin enhances effectiveness, reducing the risk of cancer progression by 59% and tripling the time patients live without disease progression. The combination is safe and effective, with many patients experiencing long-lasting improvements. These findings suggest that these treatments could greatly benefit patients with this type of lymphoma.14678
Who Is on the Research Team?
Ryan Lynch, MD
Principal Investigator
Fred Hutch/University of Washington Cancer Consortium
Are You a Good Fit for This Trial?
Adults with untreated indolent B-cell non-Hodgkin lymphoma who have symptoms like pain, organ enlargement, or low blood counts due to the disease. They must be able to perform daily activities (0-2 on ECOG scale), have adequate organ function, and agree to use effective contraception. Excluded are pregnant women, those with certain infections or autoimmune diseases, recent monoclonal antibody treatment, uncontrolled illnesses, or a history of other cancers.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part A
Patients receive mosunetuzumab subcutaneously on days 1, 8, and 15 of cycle 1 and day 1 of subsequent cycles. Treatment repeats every 21 days for 8 cycles.
Treatment Part B
Patients who do not achieve a complete response receive obinutuzumab and polatuzumab vedotin intravenously. Treatment repeats every 21 days for 6 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion.
What Are the Treatments Tested in This Trial?
Interventions
- Mosunetuzumab
- Obinutuzumab
- Polatuzumab Vedotin
Mosunetuzumab is already approved in European Union, United States for the following indications:
- Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
- Relapsed or refractory follicular lymphoma after two or more lines of systemic therapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Washington
Lead Sponsor
Genentech, Inc.
Industry Sponsor
Ashley Magargee
Genentech, Inc.
Chief Executive Officer since 2024
MBA from Harvard University, BA from Princeton University
Levi Garraway
Genentech, Inc.
Chief Medical Officer since 2021
MD, PhD