Trial Outcomes & Findings for QUILT-3.028: Study of haNK™ for Infusion in Subjects With Metastatic or Locally Advanced Solid Tumors (NCT NCT03027128)
NCT ID: NCT03027128
Last Updated: 2024-11-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
6 participants
Primary outcome timeframe
28 days/4 weeks
Results posted on
2024-11-20
Participant Flow
Only Cohort 1 enrolled participants on this study.
Participant milestones
| Measure |
Cohort 1, 2x10^9 Cells haNK™
NK-92 \[CD16.158V, ER IL-2\], Suspension for Intravenous Infusion
haNK™ for Infusion: haNK™ for Infusion is a human, allogeneic, NK cell line that has been engineered to produce endogenous, intracellularly retained IL-2 and to express CD16, the high-affinity (158V) Fc gamma receptor (FcγRIIIa/CD16a).
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|---|---|
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Overall Study
STARTED
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6
|
|
Overall Study
COMPLETED
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6
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
QUILT-3.028: Study of haNK™ for Infusion in Subjects With Metastatic or Locally Advanced Solid Tumors
Baseline characteristics by cohort
| Measure |
Cohort 1, 2x10^9 Cells haNK™
n=6 Participants
NK-92 \[CD16.158V, ER IL-2\], Suspension for Intravenous Infusion
haNK™ for Infusion: haNK™ for Infusion is a human, allogeneic, NK cell line that has been engineered to produce endogenous, intracellularly retained IL-2 and to express CD16, the high-affinity (158V) Fc gamma receptor (FcγRIIIa/CD16a).
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|---|---|
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Age, Continuous
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52.0 years
STANDARD_DEVIATION 11.78 • n=5 Participants
|
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Sex: Female, Male
Female
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4 Participants
n=5 Participants
|
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Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
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0 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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5 Participants
n=5 Participants
|
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
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0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
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4 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Histology of Primary Diagnosis
Carcinoma/Adenocarcinoma
|
4 Participants
n=5 Participants
|
|
Histology of Primary Diagnosis
Epithelial
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1 Participants
n=5 Participants
|
|
Histology of Primary Diagnosis
Squamous cell carcinoma
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days/4 weeksPopulation: All subjects that received at least one dose of study drug.
Outcome measures
| Measure |
Cohort 1: 2 x 10^9 Cells haNK™
n=6 Participants
NK-92 \[CD16.158V, ER IL-2\], Suspension for Intravenous Infusion
haNK™ for Infusion: haNK™ for Infusion is a human, allogeneic, NK cell line that has been engineered to produce endogenous, intracellularly retained IL-2 and to express CD16, the high-affinity (158V) Fc gamma receptor (FcγRIIIa/CD16a).
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|---|---|
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Determination of Maximum Tolerated Dose (MTD) or Highest Tested Dose (HTD).
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2,000,000,000 cells
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PRIMARY outcome
Timeframe: 28 days/4 weeksPopulation: All subjects that received at least one dose of study drug.
Outcome measures
| Measure |
Cohort 1: 2 x 10^9 Cells haNK™
n=6 Participants
NK-92 \[CD16.158V, ER IL-2\], Suspension for Intravenous Infusion
haNK™ for Infusion: haNK™ for Infusion is a human, allogeneic, NK cell line that has been engineered to produce endogenous, intracellularly retained IL-2 and to express CD16, the high-affinity (158V) Fc gamma receptor (FcγRIIIa/CD16a).
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|---|---|
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Occurrence of Dose-limiting Toxicities (DLTs).
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0 Number of DLTs
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PRIMARY outcome
Timeframe: The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.Population: All subjects that received at least one dose of study drug.
Outcome measures
| Measure |
Cohort 1: 2 x 10^9 Cells haNK™
n=6 Participants
NK-92 \[CD16.158V, ER IL-2\], Suspension for Intravenous Infusion
haNK™ for Infusion: haNK™ for Infusion is a human, allogeneic, NK cell line that has been engineered to produce endogenous, intracellularly retained IL-2 and to express CD16, the high-affinity (158V) Fc gamma receptor (FcγRIIIa/CD16a).
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|---|---|
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Number of Participants With Treatment-emergent Adverse Event (AEs) and Serious Adverse Events (SAEs)
Treatment-emergent adverse event
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6 participants
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Number of Participants With Treatment-emergent Adverse Event (AEs) and Serious Adverse Events (SAEs)
Serious adverse events
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1 participants
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Adverse Events
Cohort 1: 2 x 10^9 Cells haNK™
Serious events: 1 serious events
Other events: 6 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Cohort 1: 2 x 10^9 Cells haNK™
n=6 participants at risk
NK-92 \[CD16.158V, ER IL-2\], Suspension for Intravenous Infusion
haNK™ for Infusion: haNK™ for Infusion is a human, allogeneic, NK cell line that has been engineered to produce endogenous, intracellularly retained IL-2 and to express CD16, the high-affinity (158V) Fc gamma receptor (FcγRIIIa/CD16a).
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|---|---|
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
|
16.7%
1/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Other adverse events
| Measure |
Cohort 1: 2 x 10^9 Cells haNK™
n=6 participants at risk
NK-92 \[CD16.158V, ER IL-2\], Suspension for Intravenous Infusion
haNK™ for Infusion: haNK™ for Infusion is a human, allogeneic, NK cell line that has been engineered to produce endogenous, intracellularly retained IL-2 and to express CD16, the high-affinity (158V) Fc gamma receptor (FcγRIIIa/CD16a).
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|---|---|
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Gastrointestinal disorders
Abdominal distension
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16.7%
1/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Gastrointestinal disorders
Abdominal pain
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33.3%
2/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Gastrointestinal disorders
Constipation
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50.0%
3/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Gastrointestinal disorders
Diarrhoea
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16.7%
1/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Gastrointestinal disorders
Dyspepsia
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16.7%
1/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Gastrointestinal disorders
Nausea
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33.3%
2/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Gastrointestinal disorders
Vomiting
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33.3%
2/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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General disorders
Asthenia
|
16.7%
1/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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General disorders
Fatigue
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83.3%
5/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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General disorders
Pyrexia
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16.7%
1/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Hepatobiliary disorders
Hyperbilirubinaemia
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16.7%
1/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Injury, poisoning and procedural complications
Infusion related reaction
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33.3%
2/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Injury, poisoning and procedural complications
Rib fracture
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16.7%
1/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Metabolism and nutrition disorders
Hypercalcaemia
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16.7%
1/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Metabolism and nutrition disorders
Hyperkalaemia
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16.7%
1/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Metabolism and nutrition disorders
Hypoglycaemia
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33.3%
2/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Metabolism and nutrition disorders
Hyponatraemia
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16.7%
1/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Musculoskeletal and connective tissue disorders
Back pain
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33.3%
2/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Musculoskeletal and connective tissue disorders
Bone pain
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16.7%
1/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Musculoskeletal and connective tissue disorders
Muscle spasms
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16.7%
1/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer metastatic
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16.7%
1/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Nervous system disorders
Headache
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16.7%
1/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
|
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Nervous system disorders
Neuropathy peripheral
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16.7%
1/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
|
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Psychiatric disorders
Depression
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16.7%
1/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Psychiatric disorders
Insomnia
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16.7%
1/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Renal and urinary disorders
Acute kidney injury
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16.7%
1/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Skin and subcutaneous tissue disorders
Pruritus
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16.7%
1/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Skin and subcutaneous tissue disorders
Rash
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16.7%
1/6 • The investigator will record all reportable events with start dates occurring any time after informed consent is obtained until 30 days after the last day of study participation, up to 5.3 months.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place