Trial Outcomes & Findings for NT-I7 for Kaposi Sarcoma in Patients With or Without HIV (NCT NCT04893018)
NCT ID: NCT04893018
Last Updated: 2024-06-27
Results Overview
Measured by Common Terminology Criteria for Adverse Events version 5.0.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
8 participants
Primary outcome timeframe
Up to 30 days after last dose of NT-I7, approximately 31 weeks total
Results posted on
2024-06-27
Participant Flow
Participant milestones
| Measure |
NT-I7 (Efineptakin Alfa) Dose Level 1
Participants receive 480 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
NT-I7 (Efineptakin Alfa) Dose Level 2
Participants receive 960 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
2
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
NT-I7 (Efineptakin Alfa) Dose Level 1
Participants receive 480 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
NT-I7 (Efineptakin Alfa) Dose Level 2
Participants receive 960 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Study Terminated
|
1
|
2
|
Baseline Characteristics
NT-I7 for Kaposi Sarcoma in Patients With or Without HIV
Baseline characteristics by cohort
| Measure |
NT-I7 (Efineptakin Alfa) Dose Level 1
n=6 Participants
Participants receive 480 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
NT-I7 (Efineptakin Alfa) Dose Level 2
n=2 Participants
Participants receive 960 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
Total
n=8 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
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 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
|
57.2 years
STANDARD_DEVIATION 7.2 • n=5 Participants
|
37.0 years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
52.1 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 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
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 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
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 days after last dose of NT-I7, approximately 31 weeks totalPopulation: Analysis is conducted on all enrolled participants who received at least one dose of NT-I7.
Measured by Common Terminology Criteria for Adverse Events version 5.0.
Outcome measures
| Measure |
NT-I7 (Efineptakin Alfa) Dose Level 1
n=6 Participants
Participants receive 480 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
NT-I7 (Efineptakin Alfa) Dose Level 2
n=2 Participants
Participants receive 960 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
|---|---|---|
|
Percentage of Participants With Adverse Events
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analysis is conducted on all enrolled participants who received at least one dose of NT-I7 and provided at least one post-baseline response assessment, and did not discontinue study treatment prior to the first protocol-specified timepoint for evaluation of response to therapy.
Defined as the proportion of participants who achieved Complete Response (CR) or Partial Response (PR) according to modified Acquired Immunodeficiency Syndrome (AIDS) Clinical Trials Group Criteria (ACTG) criteria.
Outcome measures
| Measure |
NT-I7 (Efineptakin Alfa) Dose Level 1
n=5 Participants
Participants receive 480 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
NT-I7 (Efineptakin Alfa) Dose Level 2
n=2 Participants
Participants receive 960 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
|---|---|---|
|
Objective Response Rate (ORR).
Complete Response (CR)
|
0 Participants
|
0 Participants
|
|
Objective Response Rate (ORR).
Partial Response (PR)
|
1 Participants
|
2 Participants
|
|
Objective Response Rate (ORR).
Objective Response Rate (CR+PR)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Analysis is conducted on all enrolled participants who received at least one dose of NT-I7 and provided at least one post-baseline response assessment, and did not discontinue study treatment prior to the first protocol-specified timepoint for evaluation of response to therapy.
Measured in participants who obtain a partial response or better and defined as time from the best response within the first 36 weeks of therapy until disease progression or censoring. Kaplan Meier survival estimates constructed for each of these survival endpoints with 95% confidence intervals (CIs), for up to 1 year following initiation of treatment in all participants.
Outcome measures
| Measure |
NT-I7 (Efineptakin Alfa) Dose Level 1
n=5 Participants
Participants receive 480 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
NT-I7 (Efineptakin Alfa) Dose Level 2
n=2 Participants
Participants receive 960 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
|---|---|---|
|
Duration of Response (DOR)
|
NA months
Due to insufficient number of participants, median duration of response (DOR) could not be calculated, and upper and lower confidence interval for DOR could not be obtained using Kaplan-Meier estimates.
|
NA months
Due to insufficient number of participants, median duration of response (DOR) could not be calculated, and upper and lower confidence interval for DOR could not be obtained using Kaplan-Meier estimates.
|
SECONDARY outcome
Timeframe: Assessed up to 1 yearPopulation: Analysis is conducted on all enrolled participants who received at least one dose of NT-I7 and provided at least one post-baseline response assessment, and did not discontinue study treatment prior to the first protocol-specified timepoint for evaluation of response to therapy.
Defined as the time from administration of the first dose of NT-I7 until disease progression or death or censoring. Kaplan Meier survival estimates will be constructed for each of these survival endpoints with 95% CIs, for up to 1 year following initiation of treatment in all participants.
Outcome measures
| Measure |
NT-I7 (Efineptakin Alfa) Dose Level 1
n=5 Participants
Participants receive 480 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
NT-I7 (Efineptakin Alfa) Dose Level 2
n=2 Participants
Participants receive 960 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
|---|---|---|
|
Progression-free Survival (PFS)
|
NA months
Interval 2.1 to
Due to insufficient number of participants, median progression free survival (PFS) could not be calculated.
|
NA months
Due to insufficient number of participants, median progression free survival (PFS) could not be calculated, and upper and lower confidence interval for PFS could not be obtained using Kaplan-Meier estimates.
|
SECONDARY outcome
Timeframe: Assessed up to 1 year following initiation of treatmentPopulation: Analysis is conducted on all enrolled and treated participants.
From administration of the first dose of NT-I7 until death or censoring. Kaplan Meier survival estimates will be constructed for each of these survival endpoints with 95% CIs.
Outcome measures
| Measure |
NT-I7 (Efineptakin Alfa) Dose Level 1
n=6 Participants
Participants receive 480 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
NT-I7 (Efineptakin Alfa) Dose Level 2
n=2 Participants
Participants receive 960 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
|---|---|---|
|
Overall Survival (OS)
|
NA months
Due to insufficient number of participants, median overall survival (OS) could not be calculated, and upper and lower confidence interval for OS could not be obtained using Kaplan-Meier estimates.
|
NA months
Due to insufficient number of participants, median overall survival (OS) could not be calculated, and upper and lower confidence interval for OS could not be obtained using Kaplan-Meier estimates.
|
SECONDARY outcome
Timeframe: From pre-administration to each time point following first administration (1, 4, and 9 weeks)Population: Analysis is conducted on all enrolled participants who received at least one dose of NT-I7 and provided at least one post-baseline response assessment, and did not discontinue study treatment prior to the first protocol-specified timepoint for evaluation of response to therapy.
For analysis of circulating lymphocytes, we will describe fold-change (median and range) in blood ALC. Fold change from baseline is defined as the ratio of the value at the visit to that at baseline.
Outcome measures
| Measure |
NT-I7 (Efineptakin Alfa) Dose Level 1
n=5 Participants
Participants receive 480 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
NT-I7 (Efineptakin Alfa) Dose Level 2
n=2 Participants
Participants receive 960 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
|---|---|---|
|
Effect of NT-I7 on Kinetics of Absolute Lymphocyte Counts (ALC) in Blood
Week 1
|
1.06 No units, median and IQR of ratios
Interval 0.62 to 1.1
|
1.15 No units, median and IQR of ratios
Interval 1.06 to 1.24
|
|
Effect of NT-I7 on Kinetics of Absolute Lymphocyte Counts (ALC) in Blood
Week 4
|
3.20 No units, median and IQR of ratios
Interval 3.2 to 3.47
|
3.93 No units, median and IQR of ratios
Interval 3.29 to 4.58
|
|
Effect of NT-I7 on Kinetics of Absolute Lymphocyte Counts (ALC) in Blood
Week 9
|
3.01 No units, median and IQR of ratios
Interval 2.65 to 3.12
|
3.24 No units, median and IQR of ratios
Interval 2.96 to 3.52
|
SECONDARY outcome
Timeframe: From pre-administration to each time point following first administration (1, 4, and 9 weeks)Population: Analysis is conducted on all enrolled participants who received at least one dose of NT-I7 and provided at least one post-baseline response assessment, and did not discontinue study treatment prior to the first protocol-specified timepoint for evaluation of response to therapy.
Described by fold-change (median and range) in blood CD4+ T cells. Fold change from baseline is defined as the ratio of the value at the visit to that at baseline.
Outcome measures
| Measure |
NT-I7 (Efineptakin Alfa) Dose Level 1
n=4 Participants
Participants receive 480 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
NT-I7 (Efineptakin Alfa) Dose Level 2
n=2 Participants
Participants receive 960 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
|---|---|---|
|
Effect of NT-I7 on Kinetics of CD4+ T Cells in Blood.
Week 1
|
1.26 No units, median and IQR of ratios
Interval 0.76 to 1.71
|
1.19 No units, median and IQR of ratios
Interval 0.84 to 1.54
|
|
Effect of NT-I7 on Kinetics of CD4+ T Cells in Blood.
Week 4
|
4.46 No units, median and IQR of ratios
Interval 3.07 to 5.92
|
6.30 No units, median and IQR of ratios
Interval 4.95 to 7.66
|
|
Effect of NT-I7 on Kinetics of CD4+ T Cells in Blood.
Week 9
|
3.26 No units, median and IQR of ratios
Interval 2.18 to 4.19
|
4.45 No units, median and IQR of ratios
Interval 3.42 to 5.47
|
SECONDARY outcome
Timeframe: From pre-administration to each time point following first administration (1, 4, and 9 weeks)Population: Analysis is conducted on all enrolled participants who received at least one dose of NT-I7 and provided at least one post-baseline response assessment, and did not discontinue study treatment prior to the first protocol-specified timepoint for evaluation of response to therapy.
Described by fold-change (median and range) in blood CD8+ T cells. Fold change from baseline is defined as the ratio of the value at the visit to that at baseline.
Outcome measures
| Measure |
NT-I7 (Efineptakin Alfa) Dose Level 1
n=4 Participants
Participants receive 480 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
NT-I7 (Efineptakin Alfa) Dose Level 2
n=2 Participants
Participants receive 960 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
|---|---|---|
|
Effect of NT-I7 on Kinetics of CD8+ T Cells in Blood.
Week 1
|
0.89 No units, median and IQR of ratios
Interval 0.78 to 1.14
|
1.29 No units, median and IQR of ratios
Interval 1.27 to 1.32
|
|
Effect of NT-I7 on Kinetics of CD8+ T Cells in Blood.
Week 4
|
3.25 No units, median and IQR of ratios
Interval 2.43 to 4.48
|
4.12 No units, median and IQR of ratios
Interval 3.45 to 4.79
|
|
Effect of NT-I7 on Kinetics of CD8+ T Cells in Blood.
Week 9
|
2.53 No units, median and IQR of ratios
Interval 1.84 to 3.42
|
3.28 No units, median and IQR of ratios
Interval 2.93 to 3.64
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 12 months after last dose of NT-I7The proportion of participants developing neutralizing antibodies will be summarized.
Outcome measures
Outcome data not reported
Adverse Events
NT-I7 (Efineptakin Alfa) Dose Level 1
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
NT-I7 (Efineptakin Alfa) Dose Level 2
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NT-I7 (Efineptakin Alfa) Dose Level 1
n=6 participants at risk
Participants receive 480 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
NT-I7 (Efineptakin Alfa) Dose Level 2
n=2 participants at risk
Participants receive 960 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
|---|---|---|
|
General disorders
Injection site reaction
|
16.7%
1/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
0.00%
0/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Infections and infestations
Bacteremia
|
0.00%
0/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Respiratory, thoracic and mediastinal disorders
Chylothorax
|
0.00%
0/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
Other adverse events
| Measure |
NT-I7 (Efineptakin Alfa) Dose Level 1
n=6 participants at risk
Participants receive 480 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
NT-I7 (Efineptakin Alfa) Dose Level 2
n=2 participants at risk
Participants receive 960 µg/kg NT-I7 (Efineptakin alfa) IM on day 1. Cycles repeat every 9 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity.
NT-I7 (Efineptakin alfa): Given IM
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
33.3%
2/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Blood and lymphatic system disorders
Axillary lymphadenopathy
|
0.00%
0/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Gastrointestinal disorders
Anal pain
|
0.00%
0/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
2/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
0.00%
0/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
General disorders
Chills
|
0.00%
0/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
General disorders
Fatigue
|
16.7%
1/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
0.00%
0/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
General disorders
Fever
|
16.7%
1/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
General disorders
Flu like symptoms
|
0.00%
0/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
General disorders
Generalized edema
|
0.00%
0/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
General disorders
Injection site reaction
|
66.7%
4/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
General disorders
Localized edema
|
16.7%
1/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
General disorders
Malaise
|
16.7%
1/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
0.00%
0/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Infections and infestations
Herpes simplex reactivation
|
16.7%
1/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
0.00%
0/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Infections and infestations
Papulopustular rash
|
16.7%
1/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
0.00%
0/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Infections and infestations
Prostate infection
|
16.7%
1/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
0.00%
0/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Investigations
Alanine aminotransferase increased
|
100.0%
6/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
0.00%
0/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Investigations
Aspartate aminotransferase increased
|
66.7%
4/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Investigations
CD4 Lymphocytes decreased
|
16.7%
1/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
0.00%
0/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Investigations
Creatinine increased
|
0.00%
0/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
100.0%
2/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
0.00%
0/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Investigations
Lymphocyte count increased
|
50.0%
3/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
100.0%
2/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Investigations
Platelet count decreased
|
33.3%
2/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
0.00%
0/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Investigations
Thyroid stimulating hormone increased
|
16.7%
1/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
0.00%
0/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
33.3%
2/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
0.00%
0/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
1/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
0.00%
0/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
16.7%
1/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
0.00%
0/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
16.7%
1/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
0.00%
0/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
100.0%
2/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
16.7%
1/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
0.00%
0/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Reproductive system and breast disorders
Genital edema
|
0.00%
0/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Reproductive system and breast disorders
Right breast enlargement
|
0.00%
0/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
16.7%
1/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
0.00%
0/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
50.0%
1/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
16.7%
1/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
0.00%
0/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
33.3%
2/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
0.00%
0/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
|
Vascular disorders
Flushing
|
16.7%
1/6 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
0.00%
0/2 • All-Cause Mortality was assessed through study completion, up to 12 months; serious adverse events and other (not including serious) adverse events were assessed from the time of the first dose until 30 days after the last dose of NT-I7, approximately 31 weeks total.
|
Additional Information
Clinical Trial Manager
Cancer Immunotherapy Trials Network
Phone: 206-667-2541
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place