A Pilot Phase I Trial of IL-21 Expanded, Off the Shelf, Third-Party Natural Killer (NK) Cells in Combination With Mogamulizumab in Patients With Cutaneous T-Cell Lymphomas or Adult T-Cell Leukemia/Lymphomas
John Reneau
Summary
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.
Description
PRIMARY OBJECTIVE: I. To determine safety, tolerability, and determine the maximum tolerated dose (MTD) of IL-21 expanded, off the shelf, third-party natural killer (NK) cells and mogamulizumab in patients with relapsed/refractory cutaneous T-cell lymphoma (CTCL) and adult T-cell leukemia/lymphoma (ATLL). SECONDARY OBJECTIVES: I. To determine the overall response rate (ORR), progression free survival (PFS) and overall survival (OS) in same patient population treated with IL-21 expanded, off the shelf, third-party NK cells and mogamulizumab. II. To determine impact of treatment on quality o…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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 * Note: extracorporeal photopheresis will be considered a systemic therapy for this study * Patients with large cell transformation of cutaneous T cell lymphoma are eligible * Patients with adult T-cell leukemia/lymphoma (ATLL) of any…
Interventions
- DrugCyclophosphamide
Given IV
- DrugFludarabine
Given IV
- BiologicalMogamulizumab
Given IV
- BiologicalNatural Killer Cell Therapy
Given via infusion
- OtherQuality-of-Life Assessment
Ancillary studies
- OtherQuestionnaire Administration
Ancillary studies
Location
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio