Phase I Study of Recombinant Human IL-15 (rhIL-15) and Mogamulizumab for People With Refractory or Relapsed Adult T-Cell Leukemia and Mycosis Fungoides/Sezary Syndrome

  • End date
    Sep 1, 2023
  • participants needed
  • sponsor
    National Cancer Institute (NCI)
Updated on 17 January 2021
malignant disease
ct scan
graft versus host disease
monoclonal antibodies
measurable disease
HIV Infection
immunosuppressive therapy
bone marrow procedure
adult t-cell leukemia/lymphoma
MRI Scan
neutrophil count
cancer therapy
sezary syndrome
adult t-cell leukemia
topical steroids
mycosis fungoides and sezary syndrome
pet scans



Adult T-cell leukemia/lymphoma (ATLL) and mycosis fungoides/Sezary syndrome (MF/SS) are cancers that form in the T cells, a type of white blood cell that helps with the body s immune response. A combination of drugs might be able to better treat these cancers than existing therapies.


To test if the drugs IL-15 and mogamulizumab are safe and effective to treat people with ATLL or MF/SS.


People ages 18 and older with relapsed ATLL or MF/SS that has not responded to at least one standard treatment


Participants will be screened with:

Medical history

Physical exam

Blood (including HIV, hepatitis B and C), urine, lung, and heart tests

Bone marrow tests (if needed): A needle inserted in the participant s hip will take a small amount of marrow.

CT, PET and/or MRI scans

Tumor biopsy (if needed): A needle will take out a small piece of the participant s tumor.

Participants will get the study drugs by vein for up to six 28-day cycles. They will get IL-15 the first 5 days of each cycle. They will get mogamulizumab on days 1, 8, 15, and 22 of cycle 1 and days 1 and 15 of the other cycles. They will be hospitalized for 1 week in cycle

  1. They may need to get a midline catheter. This is a soft tube put into a vein leading to the heart.

Participants will have repeats of the screening tests throughout the study.

After treatment, participants will have visits every 60 days for 6 months, every 90 days for 2 years, and then every 6 months for 2 years.


  • Advanced mycosis fungoides, its leukemic form Sezary syndrome (MF/SS), and adult T- cell leukemia/lymphoma (ATLL) are all aggressive mature T-cell malignancies which are considered incurable without an allogeneic stem cell transplant.
  • Mogamulizumab is a defucosylated monoclonal antibody directed towards CCR4, a chemokine receptor expressed by the majority of MS/SS and ATLL cells. It is approved by the United States Food and Drug Administration for treatment of relapsed MF/SS, and is recommended by the National Comprehensive Cancer Network for treatment of ATLL.
  • Defucosylation of mogamulizumab is thought to enhance its capacity for antibodydependent cell cytotoxicity (ADCC), which is mediated by natural killer (NK) cells and macrophages.
  • The immunologic effects of recombinant human Interleukin-15 (rhIL-15), a stimulatory cytokine that promotes the differentiation and activation of NK cells, monocytes and long- term CD8+ memory T-cells, has been assessed in several phase I trials in cancer patients.
  • Concomitant administration of rhIL-15 with mogamulizumab may further enhance the ADCC capacity of the antibody and result in improved efficacy for patients with CCR4- expressing cancers.

-To determine the safety and toxicity profile and the maximum tolerated dose (MTD) of continuous intravenous infusion (civ) rhIL-15 administration in combination with standard intravenous (IV) mogamulizumab treatment

  • Age greater than or equal to 18 years of age
  • ECOG performance status of less than or equal to 1
  • Histologically or cytologically confirmed mycosis fungoides/S(SqrRoot)(Copyright)zary syndrome or adult T- cell leukemia/lymphoma relapsed after or refractory to at least one line of systemic treatment.
  • Adequate organ and marrow function
  • Open-label, single-center, non-randomized phase I study
  • Standard "3 + 3" design will be used to determine the MTD of dose-escalated rhIL-15 with fixed dose of mogamulizumab, with an expansion cohort at the MTD
  • Maximum 6 cycles (28-day cycles) of combination therapy
  • To explore all dose levels, including further evaluation in a dose expansion cohort, and to account for unevaluable patients the accrual ceiling will be set at 20 patients.

Treatment Mogamulizumab, rhIL-15
Clinical Study IdentifierNCT04185220
SponsorNational Cancer Institute (NCI)
Last Modified on17 January 2021

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