Post-CAR T-cell Therapy Drug Combo for Non-Hodgkin's Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether the drug combination of mosunetuzumab and polatuzumab vedotin can control or shrink non-Hodgkin's lymphoma in patients whose cancer has returned or isn't responding to treatment. Researchers aim to determine if these drugs offer additional benefits after patients have undergone chemotherapy and CAR T-cell therapy. The trial includes different groups: some receive one drug, some receive the other, and some receive both. Suitable candidates have non-Hodgkin's lymphoma that is recurrent or unresponsive to treatment and have already had CAR T-cell therapy. As a Phase 2 trial, the 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, you cannot receive polatuzumab vedotin or mosunetuzumab as part of bridging therapy before the trial. It's best to discuss your current medications with the trial team to ensure eligibility.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that mosunetuzumab, a type of antibody treatment, is generally well-tolerated by patients with relapsed or refractory non-Hodgkin lymphoma. Most patients do not experience severe side effects. Common side effects include tiredness and mild fever, which are usually easy to manage.
For polatuzumab vedotin, research also indicates it is safe for most patients. Studies found that most people handle the treatment well. Some reported mild to moderate side effects like low blood cell counts and nausea, which are typical for cancer treatments.
When used together, mosunetuzumab and polatuzumab vedotin have shown promising results with manageable side effects. Studies suggest that combining them does not significantly increase the risk of severe side effects compared to using them separately.
Overall, both treatments have been tested in several studies, and the results suggest they are generally safe for patients with these specific types of lymphoma. However, as with any treatment, individual reactions can vary, so discussing potential risks with a healthcare provider is important.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the treatments mosunetuzumab and polatuzumab vedotin for non-Hodgkin's lymphoma because they offer innovative approaches compared to standard chemotherapy and targeted therapies like rituximab. Mosunetuzumab is a bispecific antibody that uniquely targets both CD20 on B-cells and CD3 on T-cells, prompting T-cells to attack the cancerous B-cells directly. Meanwhile, polatuzumab vedotin is an antibody-drug conjugate that combines a monoclonal antibody with a potent anti-cancer drug to deliver targeted treatment right to the cancer cells, minimizing effects on healthy cells. These advanced mechanisms could improve efficacy and reduce side effects compared to traditional treatments.
What evidence suggests that this trial's treatments could be effective for non-Hodgkin's lymphoma?
In this trial, participants will receive different treatments to evaluate their effectiveness in Non-Hodgkin's Lymphoma. Studies have shown that mosunetuzumab, which participants may receive, can lead to long-lasting improvements in patients with relapsed or hard-to-treat Follicular Lymphoma (FL), with 80% of patients responding to the treatment and 60% achieving complete remission. Research indicates that polatuzumab vedotin significantly boosts complete remission rates in patients with Non-Hodgkin’s Lymphoma (NHL), with a 52% response rate in those with relapsed or hard-to-treat Diffuse Large B-cell Lymphoma (DLBCL). Additionally, some participants will receive a combination of mosunetuzumab and polatuzumab vedotin, which has demonstrated a strong combined effect, with 88% of high-risk patients responding to the treatment and 79% achieving complete remission. These treatments work by directly targeting cancer cells, helping to control or shrink tumors more effectively.45678
Who Is on the Research Team?
Brian T Hess
Principal Investigator
SWOG Cancer Research Network
Are You a Good Fit for This Trial?
This trial is for adults with certain types of lymphoma (like diffuse large B-cell or follicular grade IIIb) that's come back or isn't responding to treatment. They should be set for CAR T-cell therapy, have a decent performance score, and functioning major organs. People can't join if they've had recent heart issues, used specific drugs as 'bridging' therapy, or if their CAR T-cells aren't FDA-approved.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Lymphodepleting Chemotherapy
Patients receive lymphodepleting chemotherapy consisting of fludarabine and cyclophosphamide, followed by CAR T-cell therapy
Consolidation Therapy
Patients are randomized to receive mosunetuzumab, polatuzumab vedotin, both, or observation
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mosunetuzumab
- Polatuzumab Vedotin
Find a Clinic Near You
Who Is Running the Clinical Trial?
SWOG Cancer Research Network
Lead Sponsor
Southwest Oncology Group
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
National Cancer Institute (NCI)
Collaborator