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

Completed · Phase 1

Conditions studied: Healthy Subjects

In brief

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.

Key facts

Study ID

NCT06040918

Run by

ImmunityBio, Inc.

People needed

10

Starts

2023-10-04

Expected to finish

2024-09-03

Last updated by the study team

2025-10-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• Chan Soon-Shiong Institute for Medicine — El Segundo, California, United States

Full record on ClinicalTrials.gov

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