Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06040918
Status:
COMPLETED
Last Update Posted:
2024-01-29
First Post:
2023-06-26
Brief Title:
Single Center Study Of N-803 Stimulation On Expansion Enrichment Proliferation Of Natural Killer Cells Collected By Apheresis
Sponsor:
ImmunityBio Inc
Organization:
ImmunityBio Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 eg injection site reaction In addition AEs will be elicited from subjects during follow-up phone calls
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 eg injection site reaction In addition AEs will be elicited from subjects during follow-up phone calls
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None