Trial Outcomes & Findings for 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 (NCT NCT04185220)

Last Updated: 2023-01-04

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

6 participants

Primary outcome timeframe

28 days

Results posted on

2023-01-04

Participant Flow

Participant milestones

Participant milestones
Measure	Dose Level 1 (Interleukin-15 2mcg/kg/Day) Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 2 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.	Dose Level 2 (Interleukin-15 4mcg/kg/Day) Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.
Dose Escalation STARTED	3	3
Dose Escalation COMPLETED	3	1
Dose Escalation NOT COMPLETED	0	2
Dose Expansion STARTED	0	0
Dose Expansion COMPLETED	0	0
Dose Expansion NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Level 1 (Interleukin-15 2mcg/kg/Day) Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 2 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.	Dose Level 2 (Interleukin-15 4mcg/kg/Day) Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.
Dose Escalation Stopped treatment early due to progressive disease, dose limiting toxicity and acute renal failure	0	1
Dose Escalation Stopped treatment early on cycle 1/day 2 due to Gr 2 infusion reaction & resulting Gr 3 hip fracture	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Level 1 (Interleukin-15 2mcg/kg/Day) n=3 Participants Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 2 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.	Dose Level 2 (Interleukin-15 4mcg/kg/Day) n=3 Participants Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.	Total n=6 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	59.2 years STANDARD_DEVIATION 8.73 • n=5 Participants	45.07 years STANDARD_DEVIATION 14.04 • n=7 Participants	52.13 years STANDARD_DEVIATION 13.01 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants	3 participants n=7 Participants	6 participants n=5 Participants

PRIMARY outcome

Timeframe: 28 days

Outcome measures

Outcome measures
Measure	All Participants n=6 Participants All participants that received Dose Level 1: Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 2 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 and Dose Level 2: Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.	Dose Level 2 (Interleukin-15 4mcg/kg/Day) Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.
Maximum Tolerated Dose (MTD) of Recombinant Human Interleukin 15 (IL-15) (rhIL-15)	2 mcg/kg/day	—

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants that received Dose Level 1: Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 2 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 and Dose Level 2: Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.	Dose Level 2 (Interleukin-15 4mcg/kg/Day) n=3 Participants Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.
Number of Grade 1-4 Treatment Related Adverse Events Grade 1 Alanine aminotransferase increased	2 adverse events	1 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 1 Aspartate aminotransferase increased	2 adverse events	1 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 1 Bronchial infection	1 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 1 Chills	1 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 1 Diarrhea	1 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 1 Dysgeusia	2 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 1 Fatigue	2 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 1 Fever	9 adverse events	1 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 1 Hypomagnesemia	5 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 1 Neutrophil count decreased	1 adverse events	1 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 1 Rash maculo-papular	3 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 2 Alanine aminotransferase	1 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 2 Anemia	9 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 2 Aspartate aminotransferase	2 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 2 Capillary leak syndrome	1 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 2 Bronchial infection	1 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 2 Chills	1 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 2 Creatine phosphokinase increased	1 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 2 Diarrhea	1 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 2 Dysgeusia	1 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 2 Fatigue	1 adverse events	1 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 2 Fever	2 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 2 Infusion related reaction	1 adverse events	1 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 2 Neutrophil count decreased	1 adverse events	1 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 2 Rash maculo-papular	0 adverse events	1 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 3 Alanine aminotransferase	1 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 3 Anemia	9 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 3 Creatine phosphokinase increased	2 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 3 Fall	0 adverse events	1 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 3 Hip fracture	0 adverse events	1 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 3 Hypoalbuminemia	2 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 3 Infusion related reaction	0 adverse events	1 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 3 Rash maculo-papular	1 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 4 Acidosis	0 adverse events	1 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 4 Capillary leak syndrome	0 adverse events	1 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 4 Creatine phosphokinase increased	2 adverse events	0 adverse events
Number of Grade 1-4 Treatment Related Adverse Events Grade 4 Acute kidney injury	0 adverse events	1 adverse events

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants that received Dose Level 1: Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 2 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 and Dose Level 2: Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.	Dose Level 2 (Interleukin-15 4mcg/kg/Day) n=3 Participants Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.
Event Free Survival	4.2 Months Standard Error 1.46	2.1 Months Standard Error 0.63

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants that received Dose Level 1: Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 2 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 and Dose Level 2: Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.	Dose Level 2 (Interleukin-15 4mcg/kg/Day) n=3 Participants Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.
Progression-free Survival	4.2 Months Standard Error 1.46	2.1 Months Standard Error 0.63

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants that received Dose Level 1: Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 2 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 and Dose Level 2: Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.	Dose Level 2 (Interleukin-15 4mcg/kg/Day) n=3 Participants Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.
Number of Participants Overall Response Complete Response	0 Participants	0 Participants
Number of Participants Overall Response Partial Response	1 Participants	0 Participants
Number of Participants Overall Response Relapsed Disease/Progressive Disease	2 Participants	3 Participants
Number of Participants Overall Response Stable Disease	0 Participants	0 Participants
Number of Participants Overall Response Unconfirmed Complete Response	0 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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 of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants that received Dose Level 1: Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 2 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 and Dose Level 2: Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.	Dose Level 2 (Interleukin-15 4mcg/kg/Day) n=3 Participants Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.
Number of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)	3 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	All Participants n=3 Participants All participants that received Dose Level 1: Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 2 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 and Dose Level 2: Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.	Dose Level 2 (Interleukin-15 4mcg/kg/Day) n=3 Participants Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.
Number of Participants With a Dose-limiting Toxicity (DLT) Possibly, Probably or Definitely Related to Interleukin 15 (IL-15) or Mogamulizumab. Possibly related to Interleukin 15	0 Participants	0 Participants
Number of Participants With a Dose-limiting Toxicity (DLT) Possibly, Probably or Definitely Related to Interleukin 15 (IL-15) or Mogamulizumab. Probably related to Interleukin 15	0 Participants	0 Participants
Number of Participants With a Dose-limiting Toxicity (DLT) Possibly, Probably or Definitely Related to Interleukin 15 (IL-15) or Mogamulizumab. Definitely related to Interleukin 15	0 Participants	2 Participants
Number of Participants With a Dose-limiting Toxicity (DLT) Possibly, Probably or Definitely Related to Interleukin 15 (IL-15) or Mogamulizumab. Possibly related to mogamulizumab	0 Participants	0 Participants
Number of Participants With a Dose-limiting Toxicity (DLT) Possibly, Probably or Definitely Related to Interleukin 15 (IL-15) or Mogamulizumab. Probably related to mogamulizumab	0 Participants	0 Participants
Number of Participants With a Dose-limiting Toxicity (DLT) Possibly, Probably or Definitely Related to Interleukin 15 (IL-15) or Mogamulizumab. Definitely related to mogamulizumab	0 Participants	0 Participants

Adverse Events

Dose Level 1 (Interleukin-15 2mcg/kg/Day)

Serious events: 3 serious events

Other events: 3 other events

Deaths: 2 deaths

Dose Level 2 (Interleukin-15 4mcg/kg/Day)

Serious events: 2 serious events

Other events: 3 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Kevin Conlon

National Cancer Institute

Phone: 240-858-3570

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Dose Level 1 (Interleukin-15 2mcg/kg/Day) n=3 participants at risk Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 2 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.	Dose Level 2 (Interleukin-15 4mcg/kg/Day) n=3 participants at risk Interleukin-15 (IL-15) by continuous intravenous (CIV) infusion at 4 mcg/kg/day on days 1-5 of each 28-day cycle (max 6 cycles) with mogamulizumab by intravenous (IV) infusion at a dose of 1 mg/kg days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle to determine MTD.
Metabolism and nutrition disorders Acidosis	0.00% 0/3 • 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.	33.3% 1/3 • Number of events 1 • 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.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • 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.	33.3% 1/3 • Number of events 1 • 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.
Infections and infestations Bacteremia	33.3% 1/3 • Number of events 1 • 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.	0.00% 0/3 • 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.
Investigations CPK increased	33.3% 1/3 • Number of events 1 • 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.	0.00% 0/3 • 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.
Vascular disorders Capillary leak syndrome	0.00% 0/3 • 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.	33.3% 1/3 • Number of events 1 • 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.
Infections and infestations Catheter related infection	33.3% 1/3 • Number of events 1 • 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.	0.00% 0/3 • 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.
General disorders Disease progression	33.3% 1/3 • Number of events 1 • 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.	0.00% 0/3 • 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.
Gastrointestinal disorders Duodenal hemorrhage	0.00% 0/3 • 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.	33.3% 1/3 • Number of events 2 • 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.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • 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.	33.3% 1/3 • Number of events 1 • 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.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/3 • 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.	33.3% 1/3 • Number of events 1 • 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.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/3 • 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.	33.3% 1/3 • Number of events 1 • 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.
Respiratory, thoracic and mediastinal disorders Hypoxia	33.3% 1/3 • Number of events 1 • 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.	0.00% 0/3 • 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.
General disorders Multi organ failure	0.00% 0/3 • 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.	33.3% 1/3 • Number of events 1 • 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.
Musculoskeletal and connective tissue disorders Myositis	33.3% 1/3 • Number of events 1 • 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.	0.00% 0/3 • 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.
Skin and subcutaneous tissue disorders Rash maculo-papular	33.3% 1/3 • Number of events 1 • 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.	0.00% 0/3 • 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.