Combination Immunotherapy for Non-Hodgkin's Lymphoma
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this research study is to test if a combination treatment of chimeric antigen receptor (CAR) T-cell therapy, Mosunetuzumab, and Polatuzumab Vedotin will result in tumor reduction.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, it mentions that systemic immunosuppressive agents and certain biologic agents or chemotherapy are not allowed within specific time frames before starting the trial treatment. It's best to discuss your current medications with the trial team to understand any necessary adjustments.
What safety data exists for CAR-T cell therapy in humans?
CAR-T cell therapy has been associated with some serious side effects, including cytokine release syndrome (a severe immune reaction) and neurotoxicity (nerve damage). These side effects can be more severe in patients with a high tumor burden (large amount of cancer). Efforts are ongoing to improve the safety of this treatment.12345
What makes the combination immunotherapy treatment for Non-Hodgkin's Lymphoma unique?
This treatment is unique because it combines CAR-T cell therapy, which uses modified immune cells to target cancer, with polatuzumab vedotin, an antibody-drug conjugate that delivers a toxin directly to cancer cells, and mosunetuzumab, which helps activate the immune system against the cancer. This combination aims to enhance the effectiveness of treatment by using different mechanisms to attack the lymphoma.678910
What data supports the effectiveness of the drug polatuzumab vedotin for treating non-Hodgkin's lymphoma?
Polatuzumab vedotin has shown significant clinical activity and an acceptable safety profile in treating relapsed or refractory B-cell non-Hodgkin's lymphoma, particularly when combined with other therapies like rituximab and bendamustine, leading to its approval for use in patients who have tried at least two other treatments.678911
Who Is on the Research Team?
Lazaros Lekakis
Principal Investigator
University of Miami
Are You a Good Fit for This Trial?
Adults aged 18-80 with aggressive Non-Hodgkin's Lymphoma that is resistant or has returned after treatment. They must have at least one measurable lesion, be in relatively good health (ECOG 0-2), and meet specific blood count criteria. Women of childbearing age need a negative pregnancy test and agree to use contraception.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Phase
Participants receive Mosunetuzumab on Days -42, -35, -28, and -7; and Polatuzumab on Day -28. Evaluation in clinic on Day -6.
CAR-T Treatment Phase
Participants receive lymphodepleting chemotherapy for three consecutive days beginning on Day -5, followed by CAR-T Cell therapy via infusion on Day 0.
Consolidation Phase
Participants receive Mosunetuzumab on Day +14; and combination Mosunetuzumab and Polatuzumab on Days +35, +56, and +77.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CAR-T Cell Therapy
- Mosunetuzumab
- Polatuzumab
CAR-T Cell Therapy is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lazaros Lekakis
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