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Cytokine

IL-15 Superagonist + Antibodies for HIV/AIDS

Phase 1
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
HIV-1 infection
On ART regimen containing an integrase inhibitor and two nucleoside reverse transcriptase inhibitors (NRTIs) or dolutegravir/lamivudine for at least 6 weeks prior to randomization
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at step 2 weeks 0, 1, 4, 7, 9, 10, 13, 16, 19, 22, 26, 32 and 46
Awards & highlights

Study Summary

This trial is testing a new drug, N-803, to see if it can help control HIV-1 without the need for antiretroviral therapy.

Who is the study for?
This trial is for adults with HIV/AIDS who've been on ART including an integrase inhibitor and NRTIs or dolutegravir/lamivudine for at least 96 weeks, have a stable CD4 count, no history of AIDS-defining illness except recurrent pneumonia, and agree to use contraception. They must not be pregnant, breastfeeding, or have used immunomodulatory meds recently.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of N-803 (an IL-15 superagonist) alone or combined with bNAbs (VRC07-523LS & 10-1074) in controlling HIV without regular treatment. Participants will temporarily stop their usual ART to see if these new drugs can maintain low HIV levels.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune activation such as fever or fatigue due to the IL-15 superagonist's action on the body's natural defenses. The broadly neutralizing antibodies might cause infusion-related reactions like mild discomfort or allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am infected with HIV-1.
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I have been on an ART regimen with specific drugs for at least 6 weeks.
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I have been on antiretroviral therapy for at least 96 weeks.
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I agree to use two forms of birth control if there's a chance I could get pregnant.
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My weight is between 50 kg and 115 kg.
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My HIV viral load has been under 50 copies/mL for the last 96 weeks.
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I agree to use barrier methods for contraception during the study.
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I have completed a leukapheresis procedure before joining.
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I have taken a pregnancy test in the last 30 days and it was negative.
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My lab results meet specific criteria for a study on my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at step 2 weeks 0, 1, 4, 7, 9, 10, 13, 16, 19, 22, 26, 32 and 46
This trial's timeline: 3 weeks for screening, Varies for treatment, and at step 2 weeks 0, 1, 4, 7, 9, 10, 13, 16, 19, 22, 26, 32 and 46 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of N-803 doses completed
Occurrence of a Grade ≥3 adverse event (AE) that is at least possibly related to N-803, as judged by the Clinical Management Committee (CMC)
Proportion of participants requiring dose reduction
+1 more
Secondary outcome measures
Cell-associated HIV-1 RNA
Measurement of HIV-1 reservoir (dQVOA)
Measurement of intact proviral DNA
+9 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B: N-803 in combination with 10-1074 and VRC07-523LSExperimental Treatment3 Interventions
Participants will receive N-803 in combination with 10-1074 and VRC07-523LS as follows: At Step 2 entry: VRC07-523LS 20 mg/kg 10-1074 30 mg/kg At Step 2, week 1: N-803 6 mcg/kg every 3 weeks for eight doses At Step 2, week 9: 10-1074 30 mg/kg
Group II: Arm A: N-803 onlyExperimental Treatment1 Intervention
Participants will receive N-803 6 mcg/kg 1 week after Step 2 entry and then every 3 weeks for a total of eight doses.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
VRC07-523LS
2019
Completed Phase 1
~310
10-1074
2019
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,265 Previous Clinical Trials
5,484,006 Total Patients Enrolled
Rockefeller UniversityOTHER
158 Previous Clinical Trials
16,311 Total Patients Enrolled
ImmunityBio, Inc.Industry Sponsor
62 Previous Clinical Trials
5,080 Total Patients Enrolled

Media Library

N-803 (Cytokine) Clinical Trial Eligibility Overview. Trial Name: NCT04340596 — Phase 1
HIV/AIDS Research Study Groups: Arm A: N-803 only, Arm B: N-803 in combination with 10-1074 and VRC07-523LS
HIV/AIDS Clinical Trial 2023: N-803 Highlights & Side Effects. Trial Name: NCT04340596 — Phase 1
N-803 (Cytokine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04340596 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any other studies investigated the potential of N-803 (IL-15 Superagonist)?

"N-803 (IL-15 Superagonist) was first researched in 2014 at Arkansas Urology. Presently, there are 17 completed trials on record and 20 that are actively seeking participants; many of these studies take place out of Chicago, Illinois."

Answered by AI

Does this study represent a pioneering effort in its field?

"N-803 (IL-15 Superagonist) trials have been conducted in 332 cities across a single country since ImmunityBio, Inc. sponsored the first phase 1 & 2 study of 596 participants which was completed back in 2014. Presently, 20 active studies for this agent are underway."

Answered by AI

Has the FDA accepted N-803 (IL-15 Superagonist) as a viable therapeutic treatment?

"The safety profile of N-803 (IL-15 Superagonist) is assessed as a 1 since it has only undergone Phase I trials, indicating that there is limited clinical evidence to support its efficacy and security."

Answered by AI

How many people are actively participating in this research endeavor?

"Affirmative. According to clinicaltrials.gov, the posting of this trial was published on May 21st 2021 and has been recently modified on September 22nd 2022. 46 individuals need to be enrolled at 12 various medical sites."

Answered by AI

Are there any recruitment opportunities for volunteers in this experiment?

"Clinicaltrials.gov has indicated that this medical study is actively seeking to add more patients, with the first post dated May 21st 2021 and most recent update on September 22nd 2022."

Answered by AI

In how many disparate locations is this experiment being conducted?

"Currently, this clinical investigation is being conducted in 12 cities across the United States. These include Chicago, Los Angeles and Boston amongst other locales. To make participation as convenient as possible for participants, it's best to choose a nearby site."

Answered by AI

Is the enrollment process open to individuals aged 35 or over?

"This study allows any patient aged 18-65 to be enrolled, as indicated by the parameters of the inclusion criteria."

Answered by AI

Could I participate in this clinical trial?

"This clinical trial is seeking 46 participants aged 18-65 with HIV. Furthermore, to be eligible for this study potential patients must have been on an antiretroviral therapy regimen containing an integrase inhibitor and two nucleoside reverse transcriptase inhibitors (NRTIs) or dolutegravir/lamivudine for at least six weeks before randomization, exhibit a QTcF interval of 440 msec within the past 90 days prior to enrollment into the program, and had their ART treatment prescribed 96 weeks ahead of being randomized."

Answered by AI
~16 spots leftby Oct 2025