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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
Must not have
ART initiated during acute infection
History of or current clinical atherosclerotic cardiovascular disease (ASCVD)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 weeks
Awards & highlights

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I started antiretroviral therapy soon after my infection was diagnosed.
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I have a history of heart disease related to artery blockage.
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I have hepatitis B or C.
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I have had cancer linked to HIV, like Kaposi's sarcoma or lymphoma.
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My HIV is resistant to drugs in two or more classes.
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I don't have any major health issues that would stop me from joining.
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I have never had Progressive Multifocal Leukoencephalopathy (PML).

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
160 Previous Clinical Trials
16,517 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)NIH
3,283 Previous Clinical Trials
5,498,896 Total Patients Enrolled
Weill Medical College of Cornell UniversityOTHER
1,064 Previous Clinical Trials
1,319,150 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
~17 spots leftby Dec 2025
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