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Monoclonal Antibodies

bNAbs + N-803 for HIV/AIDS

Phase 1
Recruiting
Led By Marina Caskey, MD
Research Sponsored by Rockefeller University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
On antiretroviral therapy with plasma HIV-1 RNA levels of < 50 copies/ml and no reported interruption of ART for 7 consecutive days or longer for at least 48 weeks, and < 20 copies/ml at screening
Confirmed HIV-1 infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 weeks
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of two long-acting broadly neutralizing antibodies, plus an IL-15 superagonist complex, in treating adults with HIV who are already on antiretroviral therapy.

Who is the study for?
Adults aged 18-70 with confirmed HIV-1 infection, on effective antiretroviral therapy for at least 48 weeks, and with a stable immune status. Participants must not have had significant interruptions in their HIV treatment, no recent malignancies or hepatitis B/C infections, and agree to use contraception.Check my eligibility
What is being tested?
The study is testing the combination of two long-acting antibodies (3BNC117-LS and 10-1074-LS) given intravenously once, plus an IL-15 superagonist complex (N-803) given subcutaneously every three weeks during a break from standard HIV treatments.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, flu-like symptoms due to immune activation by N-803, allergic responses to the antibodies administered intravenously, and possible temporary increases in viral load.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am on HIV treatment with undetectable virus levels for at least 48 weeks.
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I am HIV positive.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ART not restarted by weeks 60 and 72
ART not restarted when bNABs below threshold
Any serious adverse events
+3 more
Secondary outcome measures
Anti-drug antibodies (ADA)
Changes in HIV-1 specific T Cell immune responses
Half-life of 3BNC117-LS and 10-1074-LS
+5 more
Other outcome measures
HIV-1 specific T cell immune response changes
Latent HIV-1 reservoir composition
Neutralization sensitivity
+1 more

Side effects data

From 2022 Phase 1 trial • 6 Patients • NCT04250636
17%
Pyrosis
17%
Penile trauma
17%
Tinea capitis
17%
Seasonal allergy
17%
COVID-19
100%
80%
60%
40%
20%
0%
Study treatment Arm
Study Participants

Trial Design

1Treatment groups
Experimental Treatment
Group I: 3BNC117-LS + 10-1074-LS + N-803Experimental Treatment3 Interventions
3BNC117-LS dosed at 30 mg/kg IV, day 0 10-1074-LS dosed at 10 mg/kg IV, day 0 N-803 dosed at 6 mcg/kg, SC, 8 doses every 3 weeks (week 1 through week 22)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
3BNC117-LS
2020
Completed Phase 1
~130
10-1074-LS
2020
Completed Phase 1
~90
N803
2020
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Rockefeller UniversityLead Sponsor
158 Previous Clinical Trials
16,321 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,268 Previous Clinical Trials
5,480,680 Total Patients Enrolled
Weill Medical College of Cornell UniversityOTHER
1,054 Previous Clinical Trials
1,316,580 Total Patients Enrolled

Media Library

10-1074-LS (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05245292 — Phase 1
HIV/AIDS Research Study Groups: 3BNC117-LS + 10-1074-LS + N-803
HIV/AIDS Clinical Trial 2023: 10-1074-LS Highlights & Side Effects. Trial Name: NCT05245292 — Phase 1
10-1074-LS (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05245292 — Phase 1

Frequently Asked Questions

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

Could you provide information about the safety of 3BNC117-LS for human use?

"Our assessment of 3BNC117-LS's safety on a scale from 1 to 3 is low at 1, due to the limited clinical evidence supporting this drug's efficacy and security."

Answered by AI

Are there any open opportunities for participants in this experiment?

"According to the clinicaltrials.gov platform, this medical research is currently recruiting patients with its initial post dated December 1st 2022 and a recent edit on November 22nd 2022."

Answered by AI

What is the current participant capacity for this research trial?

"Affirmative. According to information posted on clinicaltrials.gov, this research project is recruiting participants at present time; it was first made available for application on December 1st 2022 and has been recently updated on November 22nd 2022 with the goal of enrolling 36 individuals from 3 different locations."

Answered by AI

Does this research involve participants older than 30 years of age?

"According to the trial's requirements, only patients between 18 and 70 years of age are eligible. Separately, 149 trials have been created for minors while 467 exist specifically for elderly individuals."

Answered by AI

What purpose does this clinical investigation seek to achieve?

"In this 72 week trial, the primary outcome is to identify participants who have not restarted anti-retroviral therapy (ART) by weeks 60 and 72. Secondary assessments include quantifying Treatment-related Grade 2 adverse events, calculating Time from ART withdrawal to re-initiating ART, and measuring Changes in HIV-1 specific T Cell immune responses with ELISPOT at different points throughout the study."

Answered by AI

Is there any possibility for me to partake in this investigation?

"This clinical trial is enrolling 36 adults (18 - 70 years old) with acquired immunodeficiency syndrome. Eligibility criteria include both genders, a confirmed HIV-1 infection and plasma levels of < 50 copies/ml, CD4+ T cell counts > 450 cells/mcL, CD4+ T cell % ≥ 15%, and a nadir of ≥ 200 cells/mcL. Additionally, participants that can become pregnant must have negative pregnancy tests at screening and within 48 hours prior to day 0 as well as use two forms of contraception for 12 months after the last dose of investigational product. For those engaging in"

Answered by AI
~20 spots leftby Dec 2025