Trial Outcomes & Findings for Effect of N-803 on B Cell Follicles in Antiretroviral Treated HIV Disease (NCT NCT04808908)

NCT ID: NCT04808908

Last Updated: 2024-04-02

Results Overview

Safety is a primary outcome of this phase 1b trial. Safety will be reported as the number of adverse events per participant. This includes all adverse events (total regardless of severity)

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 10 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2024-04-02

Participant Flow

Participant milestones

Measure	N-803 All participants will receive the intervention, N-803 treatment. N-803: N-803, provided by ImmunityBio., Inc. will be administered subcutaneously at a dose 6 mcg/kg on Days 0, 21, and 42 (with a dosing window of up to 14 days post the planned dosing day)
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of N-803 on B Cell Follicles in Antiretroviral Treated HIV Disease

Baseline characteristics by cohort

Measure	N-803 n=10 Participants All participants will receive the intervention, N-803 treatment. N-803: N-803, provided by ImmunityBio., Inc. will be administered subcutaneously at a dose 6 mcg/kg on Days 0, 21, and 42 (with a dosing window of up to 14 days post the planned dosing day)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Safety is a primary outcome of this phase 1b trial. Safety will be reported as the number of adverse events per participant.

This includes all adverse events (total regardless of severity)

Outcome measures

Measure	N-803 n=10 Participants All participants will receive the intervention, N-803 treatment. N-803: N-803, provided by ImmunityBio., Inc. will be administered subcutaneously at a dose 6 mcg/kg on Days 0, 21, and 42 (with a dosing window of up to 14 days post the planned dosing day)
Safety (Adverse Event Rate)	20 adverse events per participant Standard Deviation 6.2

SECONDARY outcome

Timeframe: 6 months

Frequency of CD8+ T cells in B cell follicles will be determined using flow cytometry and reported in units of cells/g tissue

Outcome measures

Measure	N-803 n=10 Participants All participants will receive the intervention, N-803 treatment. N-803: N-803, provided by ImmunityBio., Inc. will be administered subcutaneously at a dose 6 mcg/kg on Days 0, 21, and 42 (with a dosing window of up to 14 days post the planned dosing day)
Frequency of CD8+ T Cells in Follicles	29400 cells per gram of LN tissue Standard Deviation 26900

Adverse Events

N-803

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	N-803 n=10 participants at risk All participants will receive the intervention, N-803 treatment. N-803: N-803, provided by ImmunityBio., Inc. will be administered subcutaneously at a dose 6 mcg/kg on Days 0, 21, and 42 (with a dosing window of up to 14 days post the planned dosing day)
General disorders Injection site erythema	100.0% 10/10 • Number of events 30 • 6 months
General disorders Injection site induration	40.0% 4/10 • Number of events 6 • 6 months
General disorders Myalgia	90.0% 9/10 • Number of events 14 • 6 months
General disorders Fatigue or malaise	80.0% 8/10 • Number of events 13 • 6 months
General disorders Headache	80.0% 8/10 • Number of events 16 • 6 months
General disorders pain	70.0% 7/10 • Number of events 10 • 6 months
Blood and lymphatic system disorders lymphadenopathy	60.0% 6/10 • Number of events 13 • 6 months
General disorders fever	50.0% 5/10 • Number of events 10 • 6 months

Additional Information

Kevin Escandón

University of Minnesota

Phone: 612-626-9344

Email: escan012@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place