Status:
COMPLETED
Single Center Study Of N-803 Stimulation On Expansion, Enrichment, Proliferation Of Natural Killer Cells Collected By Apheresis
Lead Sponsor:
ImmunityBio, Inc.
Conditions:
Healthy Subjects
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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.
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 w...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 4 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 3 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06040918
Start Date
October 4 2023
End Date
September 3 2024
Last Update
October 14 2025
Active Locations (1)
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1
Chan Soon-Shiong Institute for Medicine
El Segundo, California, United States, 90245