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N-803 Stimulation in Healthy Subjects

Phase 1
Recruiting
Research Sponsored by ImmunityBio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years old
Healthy donors must be free of acute or chronic medical conditions (e.g., hypertension, kidney disease, diabetes, autoimmune disease, cardiovascular disease)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study day 1 through study day 24, assessed up to 24 days
Awards & highlights

Study Summary

This trial tests a drug to see how it affects cells from healthy donors in a procedure called apheresis.

Who is the study for?
This trial is for healthy adults over 18 with good organ function and no acute or chronic conditions like hypertension or diabetes. They must not be pregnant, breastfeeding, have HIV, hepatitis B/C, or been advised against donating blood. Participants need to commit up to 6 hours in the clinic and provide blood samples.Check my eligibility
What is being tested?
The study tests N-803's effects on natural killer cells collected from participants through apheresis—a procedure that separates out mononuclear cells from the blood. It's a phase 1 trial focused on understanding how this drug influences these immune cells.See study design
What are the potential side effects?
As this is an early-stage trial primarily involving healthy subjects and monitoring of immune cell behavior post-drug administration, specific side effects are not detailed but may include typical reactions related to immune stimulation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I do not have any long-term health conditions like high blood pressure, kidney disease, diabetes, autoimmune or heart diseases.
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I can sit or recline with little movement for 2-3 hours.
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I am fully active and can carry on all my pre-disease activities without restriction.
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My blood and organ tests show I am healthy enough for the trial.
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I can have needles inserted into my veins without issue.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study day 1 through study day 24, assessed up to 24 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and study day 1 through study day 24, assessed up to 24 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of serious adverse events (SAEs) and overall adverse events (AEs) coded in MedDRA
Secondary outcome measures
Evaluate and compare peripheral blood pre-apheresis and apheresis products collected without N-803 administration (unstimulated) and with N-803 administration (stimulated): - Immune profile
Evaluate and compare peripheral blood pre-apheresis and apheresis products collected without N-803 administration (unstimulated) and with N-803 administration (stimulated): - Percentage of NK cells
Evaluate and compare peripheral blood pre-apheresis and apheresis products collected without N-803 administration (unstimulated) and with N-803 administration (stimulated): - Serum cytokines
+1 more
Other outcome measures
Evaluate + compare the ex vivo expansion + enrichment of NK cells collected by apheresis without N-803 (unstimulated) + with N-803 administration (stimulated) via frequency, number, and phenotype of immune cells measured by flow + mass cytometry.
Exploratory Objective: Evaluate and compare the ex vivo expansion and enrichment of NK cells collected by apheresis without N-803 (unstimulated) and with N-803 administration (stimulated via Quality of CENK and M-CENK cells manufactured.
Exploratory Objective: Evaluate and compare the ex vivo expansion and enrichment of NK cells collected by apheresis without N-803 (unstimulated) and with N-803 administration (stimulated) via Number of days to manufacture CENK and M-CENK.

Side effects data

From 2022 Phase 2 trial • 20 Patients • NCT02989844
100%
Platelet count decreased
100%
White blood cell decreased
100%
Neutrophil count decreased
100%
Anemia
100%
Injection site reaction
100%
Hypertension
85%
Chills
75%
Hyperglycemia
75%
Dyspnea
60%
Fatigue
50%
Aspartate aminotransferase increased
50%
Rash maculo-papular
45%
Headache
40%
Edema limbs
40%
Skin and subcutaneous tissue disorders - Other, specify
40%
Fever
40%
Creatinine increased
35%
Nausea
35%
Upper respiratory infection
30%
Hypocalcemia
30%
Hypotension
25%
Lymphocyte count decreased
25%
Alanine aminotransferase increased
25%
Diarrhea
25%
Hyponatremia
20%
Hypermagnesemia
20%
Cough
20%
Vomiting
20%
Acute kidney injury
20%
Fall
20%
Hypoalbuminemia
20%
Gait disturbance
15%
Dizziness
15%
Infections and infestations - Other, specify
15%
Paronychia
10%
Weight loss
10%
Atrial Fibrillation
10%
Abdominal pain
10%
Insomnia
10%
Dry eye
10%
Hypomagnesemia
10%
Dry mouth
10%
General disorders and administration site conditions - Other, specify
10%
Alkaline phosphatase increased
5%
Dysphagia
5%
Myalgia
5%
Pain
5%
Musculoskeletal and connective tissue disorder - Other, specify
5%
Vasovagal reaction
5%
Productive cough
5%
Pneumonitis
5%
Flu like symptoms
5%
Lung infection
5%
Pericardial effusion
5%
Skin infection
5%
Peripheral sensory neuropathy
5%
Rash acneiform
5%
Anorexia
5%
Pleural effusion
5%
Pain in extremity
5%
Stomach pain
5%
Allergic reaction
5%
Neck pain
5%
Sepsis
5%
Blood bilirubin increased
5%
Blurred Vision
5%
Back pain
5%
Infections and infestations - Other,
5%
Respiratory failure
5%
Atrial fibrillation
5%
Gastroesophageal reflux disease
5%
Gastrointestinal disorders - Other, specify
5%
Vulval infection
5%
Bronchial obstruction
5%
Wheezing
5%
Erectile dysfunction
5%
Breast pain
5%
Generalized muscle weakness
5%
Immune system disorders - Other,
5%
Ear pain
5%
Nasal congestion
5%
Dry skin
5%
Mucositis oral
100%
80%
60%
40%
20%
0%
Study treatment Arm
N-803

Trial Design

1Treatment groups
Experimental Treatment
Group I: Healthy SubjectsExperimental Treatment1 Intervention
Subjects will be scheduled for first apheresis collection on study Day 1. All subjects will receive N-803 at a fixed dose of 1 mg by subcutaneous (SC) injection 4 to 5 days prior to the second apheresis collection. The study day for N-803 administration will be determined based on the planned date of the second apheresis collection.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-803
2021
Completed Phase 2
~30

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

ImmunityBio, Inc.Lead Sponsor
63 Previous Clinical Trials
5,126 Total Patients Enrolled
Leonard Sender, MDStudy DirectorImmunityBio, Inc.
1 Previous Clinical Trials
50 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is recruitment still underway for this research trial?

"Clinicaltrials.gov does not show any evidence of this trial recruiting patients in the present moment. This experiment was first posted on September 1st, 2023 and saw its last update roughly two weeks later. Although it is no longer enrolling participants, there are still 834 other active trials seeking volunteers at this time."

Answered by AI

Are there any detrimental effects to using Healthy Subjects for medical treatment?

"The safety of Healthy Subjects is assessed to be a 1 on our scale due to it being in the initial Phase 1 trial, where there are only limited data points indicating efficacy and security."

Answered by AI

Who else is applying?

What site did they apply to?
Chan Soon-Shiong Institute for Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Single Center Study Of N-803 Stimulation On Expansion, Enrichment, Proliferation Of Natural Killer Cells Collected By Apheresis
2023. "Single Center Study Of N-803 Stimulation On Expansion, Enrichment, Proliferation Of Natural Killer Cells Collected By Apheresis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06040918.
~1 spots leftby Jun 2024
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