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
CompletedPhase 1Results postedLast updated 4 January 2023
What this trial tests
Phase 1 trial testing Recombinant human Interleukin-15 (rhIL-15) in Adult T-Cell Lymphoma/Leukemia in 6 participants. Completed in 18 May 2022.
18 and older, any sex, with Adult T-Cell Lymphoma/Leukemia or Sezary Syndrome. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Maximum Tolerated Dose (MTD) of Recombinant Human Interleukin 15 (IL-15) (rhIL-15)Primary· 28 days
The MTD is the dose level at which no more than 1 of up to 6 patients experience DLT during the DLT evaluation window(s), or the dose below that at which at least 2 (of ≤6) patients have DLT. A dose-limiting toxicity (DLT) is defined as: any grade 3, 4, or 5 toxicity if not incontrovertibly due to disease progression or an extraneous cause, and deemed possibly, probably or definitely related to IL-15 or mogamulizumab.
Group
Value
95% CI
All Participants
2
Number of Grade 1-4 Treatment Related Adverse EventsPrimary· Date treatment consent signed to date off study, approximately 5 months and 25 days for dose level 1, and 4 months and 14 days for dose level 2.
Adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Grade 1 is mild. Grade 2 is moderate. Grade 3 is severe. Grade 4 is life-threatening. And Grade 5 is death related to adverse event.
Grade 1 Alanine aminotransferase increased
Group
Value
95% CI
Dose Level 1 (Interleukin-15 2mcg/kg/Day)
2
Dose Level 2 (Interleukin-15 4mcg/kg/Day)
1
Grade 1 Aspartate aminotransferase increased
Group
Value
95% CI
Dose Level 1 (Interleukin-15 2mcg/kg/Day)
2
Dose Level 2 (Interleukin-15 4mcg/kg/Day)
1
Grade 1 Bronchial infection
Group
Value
95% CI
Dose Level 1 (Interleukin-15 2mcg/kg/Day)
1
Dose Level 2 (Interleukin-15 4mcg/kg/Day)
0
Grade 1 Chills
Group
Value
95% CI
Dose Level 1 (Interleukin-15 2mcg/kg/Day)
1
Dose Level 2 (Interleukin-15 4mcg/kg/Day)
0
Grade 1 Diarrhea
Group
Value
95% CI
Dose Level 1 (Interleukin-15 2mcg/kg/Day)
1
Dose Level 2 (Interleukin-15 4mcg/kg/Day)
0
Grade 1 Dysgeusia
Group
Value
95% CI
Dose Level 1 (Interleukin-15 2mcg/kg/Day)
2
Dose Level 2 (Interleukin-15 4mcg/kg/Day)
0
Grade 1 Fatigue
Group
Value
95% CI
Dose Level 1 (Interleukin-15 2mcg/kg/Day)
2
Dose Level 2 (Interleukin-15 4mcg/kg/Day)
0
Grade 1 Fever
Group
Value
95% CI
Dose Level 1 (Interleukin-15 2mcg/kg/Day)
9
Dose Level 2 (Interleukin-15 4mcg/kg/Day)
1
Event Free SurvivalSecondary· Up to one year
Event-free survival (EFS) is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, alternative therapy for lymphoma given (such as radiation), or death, whichever occurs first.
Group
Value
95% CI
Dose Level 1 (Interleukin-15 2mcg/kg/Day)
4.2
± 1.46
Dose Level 2 (Interleukin-15 4mcg/kg/Day)
2.1
± 0.63
Progression-free SurvivalSecondary· Up to one year
Progression-free survival (PFS) is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first. Progressive Disease (PD) is new or increased lesions.
Group
Value
95% CI
Dose Level 1 (Interleukin-15 2mcg/kg/Day)
4.2
± 1.46
Dose Level 2 (Interleukin-15 4mcg/kg/Day)
2.1
± 0.63
Number of Participants Overall ResponseSecondary· 6 cycles (one cycle is 28 days)
Overall response was assessed by the Response Criteria for Adult T-cell Leukemia-Lymphoma. The response rate was determined and reported along with a 95% confidence interval. Complete Response (CR) is disappearance of all disease. Unconfirmed Complete Response (CRu) is stable residual mass in bulky lesion. Partial Response (PR) is regression of disease. Relapsed Disease (RD)/Progressive Disease (PD) is new or increased lesions. And Stable Disease (SD) is failure to attain CR/PR and no PD.
Complete Response
Group
Value
95% CI
Dose Level 1 (Interleukin-15 2mcg/kg/Day)
0
Dose Level 2 (Interleukin-15 4mcg/kg/Day)
0
Partial Response
Group
Value
95% CI
Dose Level 1 (Interleukin-15 2mcg/kg/Day)
1
Dose Level 2 (Interleukin-15 4mcg/kg/Day)
0
Relapsed Disease/Progressive Disease
Group
Value
95% CI
Dose Level 1 (Interleukin-15 2mcg/kg/Day)
2
Dose Level 2 (Interleukin-15 4mcg/kg/Day)
3
Stable Disease
Group
Value
95% CI
Dose Level 1 (Interleukin-15 2mcg/kg/Day)
0
Dose Level 2 (Interleukin-15 4mcg/kg/Day)
0
Unconfirmed Complete Response
Group
Value
95% CI
Dose Level 1 (Interleukin-15 2mcg/kg/Day)
0
Dose Level 2 (Interleukin-15 4mcg/kg/Day)
0
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)Secondary· Date treatment consent signed to date off study, approximately 5 months and 25 days for dose level 1, and 4 months and 14 days for dose level 2.
Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one
Group
Value
95% CI
Dose Level 1 (Interleukin-15 2mcg/kg/Day)
3
Dose Level 2 (Interleukin-15 4mcg/kg/Day)
3
Number of Participants With a Dose-limiting Toxicity (DLT) Possibly, Probably or Definitely Related to Interleukin 15 (IL-15) or Mogamulizumab.Secondary· First cycle of treatment (28 days)
A DLT is defined as any grade 3 (severe), 4 (life-threatening), or 5 (death related to adverse event) toxicity if not incontrovertibly due to disease progression or an extraneous cause, and deemed possibly, probably or definitely related to IL-15 or mogamulizumab.
Possibly related to Interleukin 15
Group
Value
95% CI
Dose Level 1 (Interleukin-15 2mcg/kg/Day)
0
Dose Level 2 (Interleukin-15 4mcg/kg/Day)
0
Probably related to Interleukin 15
Group
Value
95% CI
Dose Level 1 (Interleukin-15 2mcg/kg/Day)
0
Dose Level 2 (Interleukin-15 4mcg/kg/Day)
0
Definitely related to Interleukin 15
Group
Value
95% CI
Dose Level 1 (Interleukin-15 2mcg/kg/Day)
0
Dose Level 2 (Interleukin-15 4mcg/kg/Day)
2
Possibly related to mogamulizumab
Group
Value
95% CI
Dose Level 1 (Interleukin-15 2mcg/kg/Day)
0
Dose Level 2 (Interleukin-15 4mcg/kg/Day)
0
Probably related to mogamulizumab
Group
Value
95% CI
Dose Level 1 (Interleukin-15 2mcg/kg/Day)
0
Dose Level 2 (Interleukin-15 4mcg/kg/Day)
0
Definitely related to mogamulizumab
Group
Value
95% CI
Dose Level 1 (Interleukin-15 2mcg/kg/Day)
0
Dose Level 2 (Interleukin-15 4mcg/kg/Day)
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Date treatment consent signed to date off study, approximately 5 months and 25 days for dose level 1, and 4 months and 14 days for dose level 2..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Background:
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.
Objective:
To test if the drugs interleukin-15 (IL-15) and mogamulizumab are safe and effective to treat people with Adult T-Cell Leukemia and Mycosis Fungoides/Sezary Syndrome (ATLL or MF/SS).
Eligibility:
People ages 18 and older with relapsed ATLL or MF/SS that has not responded to at least one standard treatment
Design:
Participants will be screened with:
Medical history
Physical exam
Blood (including human immunodeficiency virus (HIV), hepatitis B and C), urine, lung, and heart tests
Bone marrow tests (if needed): A needle inserted in the participants hip will take a small amount of marrow.
Computed tomography (CT), positron emission tomography (PET) and/or magnetic resonance imaging (MRI) scans
Tumor biopsy (if needed): A needle will take out a small piece of the participants 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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After
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NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 4 January 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04185220.