Single Center Study Of N-803 Stimulation On Expansion, Enrichment, Proliferation Of Natural Killer Cells Collected By Apheresis

NCT06040918 | Completed Phase 1 FDA Drug

• 1 other identifier: QUILT-105
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Incidence of serious adverse events (SAEs) and overall adverse events (AEs) coded in MedDRA

  Incidence of SAEs and overall AEs coded in MedDRA

  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)

  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

  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

  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

  Study Day 1 through Study Day 24, assessed up to 24 days

Other Outcomes (3)

• 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.

  Study Day 1 through Study Day 24, assessed up to 24 days

• 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.

  Study Day 1 through Study Day 24, assessed up to 24 days

• 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.

  Study Day 1 through Study Day 24, assessed up to 24 days

Study Arms (1)

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.

Drug: N-803

Interventions

N-803 DRUG

fixed dose of 1 mg by subcutaneous (SC) injection

Healthy Subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ImmunityBio, Inc.: lead

Study Sites (1)

Chan Soon-Shiong Institute for Medicine

El Segundo, California, 90245, United States

Location

MeSH Terms

Interventions

ALT-803

Study Officials

• Leonard Sender, MD

  ImmunityBio, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Up to 10 healthy subjects

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: September 18, 2023
• Study Start: October 4, 2023
• Primary Completion: September 3, 2024
• Study Completion: September 3, 2024
• Last Updated: October 14, 2025

Record last verified: 2025-10

Locations

US (1)