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

ConditionsRecurrent Adult T-Cell Leukemia/LymphomaRecurrent Primary Cutaneous T-Cell Non-Hodgkin LymphomaRefractory Adult T-Cell Leukemia/LymphomaRefractory Primary Cutaneous T-Cell Non-Hodgkin 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Cyclophosphamide

    Drug

    Given IV

  • Fludarabine

    Drug

    Given IV

  • Mogamulizumab

    Biological/Vaccine

    Given IV

  • Natural Killer Cell Therapy

    Biological/Vaccine

    Given via infusion

  • Quality-of-Life Assessment

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: Treatment (mogamulizumab, chemotherapy, NK cells)Experimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events

Toxicities will be captured by Common Terminology Criteria for Adverse Events version 5. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. The incidence of severe adverse events or toxicities will be described. Will assess the proportion of patients who experience grade 3 or higher non-hematologic toxicity.

Time frame
Up to day 84

Secondary outcomes

1

Overall response rate (ORR)

Will be summarized in a descriptive manner. The ORR will be calculated as the proportion of patients who achieve complete response /partial response, and provided with 95% confidence interval.

Time frame
Up to 4 months
2

Progression free survival

Will be estimated using the method of Kaplan-Meier.

Time frame
From start of study treatment (from the first dose mogamulizumab [moga]) to first documentation of tumor progression (including radiographic and clinical progression) or to death due to any cause, whichever comes first, assessed up to 2 years
3

Overall survival

Will be estimated using the method of Kaplan-Meier.

Time frame
From start of study treatment to date of death due to any cause. In the absence of confirmation of death, survival time will be censored at the last date the patient is known to be alive, whichever comes first, assessed up to 2 years
4

Natural Killer (NK)-cell numerical expansion in vivo

Peripheral blood will be obtained before therapy, during the NK cell treatment period (day +42), after NK cell treatment (day +84), and at the time of progression. Donor NK-cell expansion will be defined as an absolute circulating donor-derived NK cell count that increases above the post-infusion level. Standard chimerism methods will be employed to determine origin and number of circulating NK cells.

Time frame
Baseline to day 84

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

John Reneau

Lead sponsor

Ohio State University Comprehensive Cancer Center

Sponsor institution

Source ClinicalTrials.gov
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