Healthy SubjectsPhase 1NCT06040918
Single Center Study Of N-803 Stimulation On Expansion, Enrichment, Proliferation Of Natural Killer Cells Collected By Apheresis
A Phase 1 study testing N-803 in people with Healthy Subjects, run by ImmunityBio, Inc. at 1 site in United States.
Trial summary
This is phase 1 single cohort study evaluating the effects of N-803 administration on mononuclear cells (MNC) collected from healthy donors undergoing a procedure called apheresis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- N-803
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2023to 3 Sep 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
- Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
- Adequate organ function, evidenced by the following laboratory results:
- Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 Platelet count ≥ 100,000 cells/mm3 Hemoglobin ≥ 9.0 g/dL Total bilirubin ≤ 1.5 x upper limit of normal (ULN); unless the subject has documented Gilbert's syndrome Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3 x ULN Serum creatinine ≤ 2.0 mg/dL or 177 μmol/L
- Adequate peripheral venous access.
Show all 10Show fewer
- Must be able to be in the clinic for up to 6 hours on the day of collection.
- Must be able to sit or recline with limited movement for approximately 2-3 hours.
- Must agree to provide blood samples for clinical testing and immunological analysis.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0.
Who cannot join
- Received systemic antibiotics within 14 days prior to apheresis collection.
- New York Heart Association (NYHA) functional assessment score of > Class I.
- Any medical diagnosis that would prevent the donation of WBCs.
- History of or active human immunodeficiency virus (HIV).
- Active hepatitis B or hepatitis C.
- Have been advised by a medical provider not to donate blood.
- Women who are pregnant or breastfeeding. A negative serum pregnancy test in women of child-bearing potential is required at screening.
Trial locations and contacts
1 site in 1 country.
United States1 site
Chan Soon-Shiong Institute for Medicine
El Segundo, California, 90245
About this study
Official title: Single Center Study Evaluating The Effects Of N-803 Stimulation On The Expansion, Enrichment, And Proliferation Of Natural Killer Cells Collected By Apheresis
This is phase 1 single cohort study evaluating the effects of N-803 administration on mononuclear cells (MNC) collected from healthy donors undergoing a procedure called apheresis.
Read the detailed description
This phase 1, single cohort study will enroll up to 10 healthy subjects. All subjects will be pre-screened for eligibility. If the subject meets eligibility for study participation, informed consent will be obtained. Screening will include a history and physical, review of concomitant medications, assessment of NYHA functional status, assessment of ECOG performance status, clinical laboratory tests, pregnancy test (for women of child-bearing abilities), assessment of peripheral venous access, and a donor history questionnaire (DHQ). If subjects meet eligibility criteria, they will be asked to undergo two apheresis collections and donate their mononuclear cells (MNCs) for research purposes.
Subjects will be scheduled for the first apheresis collection on study Day 1. Two total blood volume (TBV) will be processed during each apheresis collections, which is currently the collection centers standard practice. 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 N-803 dose may be administered starting on study Day 8 but no later than study Day 24. The study day for N-803 administration will be determined based on the planned date of the second apheresis collection. The second apheresis collection should occur between study Day 12 and study Day 29. Two TBV will be processed during this collection.
Subjects will be followed for collection of adverse events (AEs) from study Day 1 (first apheresis collection) through the end of study (EOS) visit. Subjects will be instructed to contact the study team in the event they experience AEs post N-803 administration (e.g., injection site reaction). In addition, AEs will be elicited from subjects during follow-up phone calls.
- Conditions
- Healthy Subjects
- Being tested
- N-803
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-803Drug
fixed dose of 1 mg by subcutaneous (SC) injection
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Experimental | 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. Receives: Drug: N-803 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of serious adverse events (SAEs) and overall adverse events (AEs) coded in MedDRA
Incidence of SAEs and overall AEs coded in MedDRA
Measured: Study Day 1 through End of Study, assessed up to 45 days
Secondary outcomes (4)
Incidence of serious adverse events (SAEs) and overall adverse events (AEs) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5.0)
Incidence of SAEs and overall AEs graded using the NCI CTCAE v5.0
Measured: Study Day 1 through End of Study, assessed up to 45 days
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
- Percentage of NK cells as measured by flow cytometry.
Measured: Study Day 1 through Study Day 24, assessed up to 24 days
Evaluate and compare peripheral blood pre-apheresis and apheresis products collected without N-803 administration (unstimulated) and with N-803 administration (stimulated): - Immune profile
- Function and cell receptor profile of NK cells as measured by intracellular staining for cytokines, surface marker staining and assessments of cytotoxicity.
Measured: Study Day 1 through Study Day 24, assessed up to 24 days
Evaluate and compare peripheral blood pre-apheresis and apheresis products collected without N-803 administration (unstimulated) and with N-803 administration (stimulated): - Serum cytokines
- Serum Cytokines
Measured: Study Day 1 through Study Day 24, assessed up to 24 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start4 Oct 2023
- Primary completion3 Sep 2024
- Study completion3 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by ImmunityBio, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Up to 10 healthy subjects
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- ImmunityBio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leonard Sender, MD, Study director, ImmunityBio, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040918
- Sponsor's protocol ID
- QUILT-105
- Status last verified
- Oct 2025
- First submitted
- 26 Jun 2023
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center Study Evaluating The Effects Of N-803 Stimulation On The Expansion, Enrichment, And Proliferation Of Natural Killer Cells Collected By Apheresis
- ClinicalTrials.gov ID
- NCT06040918
- Acronym / sponsor ID
- QUILT-105
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- ImmunityBio, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Oct 2023 (actual)
- Primary completion
- 3 Sep 2024 (actual)
- Study completion
- 3 Sep 2024 (actual)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is phase 1 single cohort study evaluating the effects of N-803 administration on mononuclear cells (MNC) collected from healthy donors undergoing a procedure called apheresis.
Detailed description
This phase 1, single cohort study will enroll up to 10 healthy subjects. All subjects will be pre-screened for eligibility. If the subject meets eligibility for study participation, informed consent will be obtained. Screening will include a history and physical, review of concomitant medications, assessment of NYHA functional status, assessment of ECOG performance status, clinical laboratory tests, pregnancy test (for women of child-bearing abilities), assessment of peripheral venous access, and a donor history questionnaire (DHQ). If subjects meet eligibility criteria, they will be asked to undergo two apheresis collections and donate their mononuclear cells (MNCs) for research purposes.
Subjects will be scheduled for the first apheresis collection on study Day 1. Two total blood volume (TBV) will be processed during each apheresis collections, which is currently the collection centers standard practice. 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 N-803 dose may be administered starting on study Day 8 but no later than study Day 24. The study day for N-803 administration will be determined based on the planned date of the second apheresis collection. The second apheresis collection should occur between study Day 12 and study Day 29. Two TBV will be processed during this collection.
Subjects will be followed for collection of adverse events (AEs) from study Day 1 (first apheresis collection) through the end of study (EOS) visit. Subjects will be instructed to contact the study team in the event they experience AEs post N-803 administration (e.g., injection site reaction). In addition, AEs will be elicited from subjects during follow-up phone calls.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Up to 10 healthy subjects
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Experimental | Drug: N-803Subjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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).
- Able to understand and provide a signed informed consent that fulfills the relevant Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
- Adequate organ function, evidenced by the following laboratory results:
- Absolute neutrophil count (ANC) ≥ 1,000 cells/mm3 Platelet count ≥ 100,000 cells/mm3 Hemoglobin ≥ 9.0 g/dL Total bilirubin ≤ 1.5 x upper limit of normal (ULN); unless the subject has documented Gilbert's syndrome Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤ 3 x ULN Serum creatinine ≤ 2.0 mg/dL or 177 μmol/L
Key exclusion criteria (7 listed)
- Received systemic antibiotics within 14 days prior to apheresis collection.
- New York Heart Association (NYHA) functional assessment score of > Class I.
- Any medical diagnosis that would prevent the donation of WBCs.
- History of or active human immunodeficiency virus (HIV).
- Active hepatitis B or hepatitis C.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-803fixed dose of 1 mg by subcutaneous (SC) injection | Drug | Healthy Subjects |
Primary outcome
Incidence of serious adverse events (SAEs) and overall adverse events (AEs) coded in MedDRA
Time frame: Study Day 1 through End of Study, assessed up to 45 days
Incidence of SAEs and overall AEs coded in MedDRA
4 secondary outcomes
Incidence of serious adverse events (SAEs) and overall adverse events (AEs) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5.0)
Time frame: Study Day 1 through End of Study, assessed up to 45 days
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
Time frame: Study Day 1 through Study Day 24, assessed up to 24 days
Evaluate and compare peripheral blood pre-apheresis and apheresis products collected without N-803 administration (unstimulated) and with N-803 administration (stimulated): - Immune profile
Time frame: Study Day 1 through Study Day 24, assessed up to 24 days
Evaluate and compare peripheral blood pre-apheresis and apheresis products collected without N-803 administration (unstimulated) and with N-803 administration (stimulated): - Serum cytokines
Time frame: Study Day 1 through Study Day 24, assessed up to 24 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
Related trials for Healthy Subjects
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonard Sender, MD study director
ImmunityBio, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing N-803 in people with Healthy Subjects, run by ImmunityBio, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of serious adverse events (SAEs) and overall adverse events (AEs) coded in MedDRA (time frame: Study Day 1 through End of Study, assessed up to 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.