Actively Recruiting
Third-Party Natural Killer Cells and Mogamulizumab for the Treatment of Relapsed or Refractory Cutaneous T-cell Lymphomas or Adult T-Cell Leukemia/Lymphoma
Led by John Reneau · Updated on 2026-02-10
12
Participants Needed
1
Research Sites
247 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Third-Party Natural Killer Cells and Mogamulizumab for the Treatment of Relapsed or Refractory Cutaneous T-cell Lymphomas or Adult T-Cell Leukemia/Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to understand and voluntarily sign an informed consent form
- Age 18 years or older
- Able to adhere to study visit schedule and protocol requirements
- Biopsy-proven, measurable, stage IB-IVB relapsed or refractory cutaneous T-cell lymphoma after one prior systemic therapy
- Patients with large cell transformation of cutaneous T-cell lymphoma are eligible
- Patients with adult T-cell leukemia/lymphoma of any stage and subtype with at least one prior standard chemotherapy and measurable disease
- Patients who relapsed after autologous or allogeneic stem cell transplant are eligible
- All cancer therapies must have been stopped at least one week or 3 half-lives before study treatment, except stable corticosteroids use as described
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Absolute neutrophil count at least 1000/mm^3
- Platelet count at least 50,000/mm^3
- Total bilirubin less than or equal to 2 times upper limit of normal
- AST and ALT less than or equal to 3 times upper limit of normal, or up to 5 times if hepatic lymphoma involvement
- Creatinine clearance at least 50 ml/min
- Disease free of prior malignancies for at least 2 years with some exceptions
- Negative pregnancy test for females of childbearing potential
- Willingness to use effective birth control if able to get pregnant
- Life expectancy of at least 90 days
You will not qualify if you...
- Received investigational therapies within 2 weeks before study treatment
- Active central nervous system involvement with lymphoma
- Known HIV infection with CD4 count below 350
- History of solid organ transplant
- Active hepatitis B or C infection
- History or presence of progressive multifocal leukoencephalopathy (PML)
- Active grade II-IV acute or extensive chronic graft versus host disease
- Steroid use not meeting inclusion criteria
- Any illness or condition that may compromise safety
- New York Heart Association class 2 or higher cardiovascular disability
- History of severe allergic reactions to humanized monoclonal antibodies
- History of other malignancies that affect compliance or results except certain skin and early prostate cancers
- Known hypersensitivity to study drugs
- Active infections requiring treatment or recent major infections
- Significant liver disease
- Receipt of live-virus vaccines within 28 days before treatment
- Recent major surgery within 6 weeks before treatment
- Receiving immunosuppressive therapy
- Prior mogamulizumab therapy unless stopped for reasons other than progression or toxicity
- Pregnant or breastfeeding or intending pregnancy during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
T
The Ohio State University Comprehensive Cancer Center
CONTACT
T
Thomas Needham
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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