Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 16 of 16

List	Outcome	Time frame	Description
Primary	Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)	From beginning of Cycle 1 (each cycle is 28 days) to 30 days after end of treatment study visit.	TEAEs and SAEs graded using the NCI CTCAE v5.0
Primary	Incidence of clinically significant changes in comprehensive metabolic panel (CMP)	From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and each subsequent treatment Cycle on Days 1 and Day 15 and at the end of treatment study visit.	Standard blood chemistry panel made up of 14 separate chemistry measurements so can detect a range of abnormalities in blood sugar, nutrient balance, and liver and kidney health. Each clinical site will use their local laboratory upper limit of normal (ULN) range. The treating investigator will assess each result composing the CMP and determine if each result is within expected normal range or outside of the expected normal range.
Primary	Incidence of clinically significant changes in Hematology blood panel.	From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and each subsequent treatment Cycle on Days 1 and Day 15 and at the end of treatment study visit.	Blood test checking the levels for White Blood Cell, Red Blood Cell, Platelets, Hemoglobin, Hematocrit, Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils per unit volume. Each clinical site will use their local laboratory upper limit of normal (ULN) range. The treating investigator will assess each component of the Hematology panel and determine if each result is within expected normal range or outside of the expected normal range.
Primary	Incidence of clinically significant changes in Urinalysis.	From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and each subsequent treatment Cycle on Days 1 and Day 15 and at the end of treatment study visit.	Checking the appearance, concentration and content of urine for any abnormalities. Each clinical site will use their local laboratory upper normal limit (UNL) range. The treating investigator will assess each component of the urinalysis and determine if each result is within expected normal range or outside of the expected normal range.
Primary	12-lead Electrocardiogram (ECG)	From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and each subsequent Cycle Day1 through to the end of treatment study visit.	Perform 12-lead ECG as safety monitoring measurement. The parameters to be assessed for each one are the following: QT Interval, QTc Interval, QTcB Interval, QTcF Interval, PR Interval, QRS Duration and RR Interval with the unit in msec.
Primary	Incidence of clinically significant changes in Temperature	From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and Cycle 2 on days 1, 2 and 15, followed by each subsequent treatment Cycle on Days 1 and 15 and on the end of treatment study visit.	Temperature measured in either Fahrenheit or Celsius and for any abnormalities. Each site will assess to determine if temperature is within expected normal range or outside of the expected normal range.
Primary	Incidence of clinically significant changes in Heart Rate	From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and Cycle 2 on days 1, 2 and 15, followed by each subsequent treatment Cycle on Days 1 and 15 and on the end of treatment study visit.	Heart rate measured in beats/minute. Each site will assess to determine if heart rate is within expected normal range or outside of the expected normal range.
Primary	Incidence of clinically significant changes in Respiratory Rate	From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and Cycle 2 on days 1, 2 and 15, followed by each subsequent treatment Cycle on Days 1 and 15 and on the end of treatment study visit.	Respiratory rate measured in breaths/minute. Each site will assess to determine if respiratory rate is within expected normal range or outside of the expected normal range.
Primary	Incidence of clinically significant changes in Blood Pressure	From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and Cycle 2 on days 1, 2 and 15, followed by each subsequent treatment Cycle on Days 1 and 15 and on the end of treatment study visit.	Blood pressure measured in Systolic and Diastolic mmHg. Each site will assess to determine if blood pressure is within expected normal range or outside of the expected normal range.
Primary	Incidence of clinically significant changes in Oxygen Saturation	From baseline, pre-intervention, Cycle 1 (each cycle is 28 days) and Cycle 2 on days 1, 2 and 15, followed by each subsequent treatment Cycle on Days 1 and 15 and on the end of treatment study visit.	A pulse oximeter measures oxygen saturation as a percentage. Determines the ratio of the current levels of oxygenated hemoglobin to deoxygenated hemoglobin. Each site will assess to determine if oxygen saturation is within expected normal range or outside of the expected normal range.
Primary	Neurological assessment to grade Immune effector cell-associated neurotoxicity syndrome (ICANS)	On Cycle 1 (each cycle is 28 days) Day1, Day2, Day 15 and Day16, followed by each subsequent treatment Cycle on Days 1 and 15. Collection stops at the end of treatment study visit.	Using a 10-point immune effector cell encephalopathy \[ICE\] score for the grading of ICANS. A score of 10 represents no impairment, 7-9 score is grade 1 ICANS, 3-6 score is grade 2 ICANS, 0-2 score is grade 3 ICANS and finally grade 4 ICANs is where cannot perform assessment of tasks.
Primary	Safety assessed by Cytokine Levels	From Cycle 1 (each cycle is 28 days) Day1, Day2, Day 15 and Day16, followed by each subsequent treatment Cycle on Day 1. Collection stops at the end of treatment study visit.	The safety cytokine levels are TNF-α and IL-6
Secondary	Concentration of N-803 Pharmacokinetic (PK)	On Cycle 1 (each cycle is 28 days) and Cycle 3 on treatment days 1, 2, 3, 4, 5 and 8.	Profile of each participant PK profile of N-803 from their serum sample
Secondary	Concentration of PD-L1 t-haNK Pharmacokinetic (PK)	On Cycle 1 (each cycle is 28 days) and Cycle 3 on treatment days 1, 2, 3, 4, 5 and 8.	Profile of each participant PK profile of PD-L1 t-haNK from their serum sample
Secondary	Detection of Immunogenicity of N-803	On Cycle 1 (each cycle is 28 days) Cycle 2 on treatment days 1 and 15, followed by Cycle 7 Day 1 and at the End of Treatment study visit.	Detection of N-803 in each participant ADA serum blood samples
Secondary	Detection of Immunogenicity of PD-L1 t-haNK	On Cycle 1 (each cycle is 28 days) Cycle 2 on treatment days 1 and 15, followed by Cycle 7 Day 1 and at the End of Treatment study visit.	Detection of PD-L1 t-haNK in each participant ADA serum blood samples

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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