Third-Party Natural Killer Cells and Mogamulizumab for the Treatment of Relapsed or Refractory Cutaneous T-cell Lymphomas or Adult T-Cell Leukemia/Lymphoma

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorJohn Reneau

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

12 Participants
are divided into 1 treatment group

Sponsors and collaborators

John Reneau

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution