About 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.
Eligibility criteria
Qualifiers
Able to understand and voluntarily sign an informed consent form
Age >= 18 years at the time of signing the informed consent form
Able to adhere to the study visit schedule and other protocol requirements
Biopsy-proven, measurable, stage IB-IVB relapsed or refractory cutaneous T-cell lymphoma after 1 prior line of systemic therapy
Disqualifiers
Investigational therapies in the 2 weeks prior to beginning treatment on trial
Patients with active central nervous system (CNS) involvement with lymphoma
Patients with known human immunodeficiency virus (HIV) infection with CD4 < 350
Patients who had solid organ transplants
Trial design
Treatments tested in this trial
- Cyclophosphamide
- Fludarabine
- Mogamulizumab
- Natural Killer Cell Therapy
- Quality-of-Life Assessment
- Questionnaire Administration
Treatment groups
Sponsors and collaborators
John Reneau
Lead sponsor
Ohio State University Comprehensive Cancer Center
Sponsor institution