NK Cell Therapy + Mogamulizumab for T-Cell Lymphoma/Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase I trial is to find out the best dose, possible benefits and/or side effects of third-party natural killer cells in combination with mogamulizumab in treating patients with cutaneous T-cell lymphoma or adult T-cell leukemia/lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with third-party natural killer cells, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Mogamulizumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving third-party natural killer cells in combination with mogamulizumab may kill more cancer cells.
Will I have to stop taking my current medications?
The trial requires that all cancer therapies, including radiation, topical steroids, and chemotherapy, be stopped at least 1 week or 3 half-lives before starting the study, except for certain corticosteroids. Participants can continue medications for other conditions if there is evidence of T-cell lymphoma progression while on these medications.
Is NK Cell Therapy + Mogamulizumab safe for humans?
Natural killer (NK) cells have shown a proven safety profile in cancer treatments, and they are considered safer than some other cell therapies. Mogamulizumab, also known as Poteligeo, is a medication used for certain types of cancer and has been evaluated for safety in humans, though specific safety data for the combination with NK cells is limited.12345
How is the NK Cell Therapy + Mogamulizumab treatment different from other treatments for T-Cell Lymphoma/Leukemia?
This treatment is unique because it combines mogamulizumab, a monoclonal antibody that targets a specific receptor on cancer cells, with natural killer (NK) cells, which are immune cells that help destroy cancer cells. Mogamulizumab enhances the body's immune response at lower doses, and the addition of NK cells aims to further boost the immune system's ability to fight the cancer.678910
What data supports the effectiveness of the drug mogamulizumab for T-cell lymphoma/leukemia?
Mogamulizumab has shown promising results in treating adult T-cell leukemia/lymphoma (ATL) and other T-cell lymphomas, with studies indicating it is effective and well-tolerated in patients with relapsed or refractory conditions. It has been approved in Japan for ATL and demonstrated significant improvement in progression-free survival for other T-cell lymphomas, suggesting its potential utility in these aggressive cancers.6781112
Who Is on the Research Team?
John C Reneau, MD, PhD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
Adults over 18 with relapsed or refractory cutaneous T-cell lymphoma or adult T-cell leukemia/lymphoma, who've had at least one prior systemic therapy. Participants must have adequate organ function and performance status, not be pregnant, and free from severe allergies to monoclonal antibodies or certain infections. Those with a history of other cancers may join if they've been disease-free for two years.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive mogamulizumab IV, fludarabine IV, and cyclophosphamide IV, followed by NK cell infusion every 2 weeks for six infusions total
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for progression free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Mogamulizumab
- Third-Party Natural Killer Cells
Mogamulizumab is already approved in European Union, United States, Canada, Japan for the following indications:
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Who Is Running the Clinical Trial?
John Reneau
Lead Sponsor