Human Immunodeficiency VirusPhase 1NCT05245292

3BNC117-LS and 10-1074-LS Plus N-803 (bNAb+N-803)

A Phase 1 study testing 3BNC117-LS, 10-1074-LS and N803 in people with Human Immunodeficiency Virus, run by Rockefeller University at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Human Immunodeficiency Virus
What is being tested?: 3BNC117-LS, 10-1074-LS and N803
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 3 sitesUnited States
Study dates: 7 Dec 2022to 31 Dec 2025
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and females, age 18 to 70.
Confirmed HIV-1 infection.
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.
NOTE: At least two Viral Load (VL) measurements within 48 weeks prior to the Step 0 screening visit must be available for review. A single plasma HIV-1 RNA > 50 copies/mL but < 200 copies/mL that is followed by an HIV-1 RNA <50 copies/mL is permitted.
Current CD4+ T cell counts > 450 cells/mcL, CD4+ T cell % ≥ 15%, and CD4+ T cell count nadir of ≥ 200 cells/mcL.
If on an NNRTI-based regimen, willing to switch to an integrase inhibitor-based regimen for at least 4 weeks prior to discontinuing ART.

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For participants who can become pregnant (i.e., participants who have not been post-menopausal for at least 24 consecutive months, who have had menses within the preceding 24 months, or who have not undergone surgical sterilization, specifically hysterectomy and/or bilateral oophorectomy), negative pregnancy test at screening (Step 0) and within 48 hours prior to day 0 (Step 1 entry).
Participants who can become pregnant must agree to use two methods of contraception, one of which must be from the highly effective methods for contraception listed below. Barrier methods of contraception are permitted for the second method of contraception. Contraception must be used from 10 days prior to the first of the investigational products (IP), while receiving the IPs, for 12 months after the last IP dose and until ART is reinitiated and viral suppression is achieved.
Participants who can impregnate a partner and who are engaging in sexual activity that could lead to pregnancy must agree to use condoms from 10 days prior to the first dose of the investigational products (IP), while receiving the IPs, and for 12 months after the last IP dose to avoid impregnating a partner who can get pregnant.
Willingness to use barrier protection (male or female) during sexual activity during analytical treatment interruption (ATI) and until viral re-suppression for those who re-start ART.

Who cannot join

History of AIDS-defining illness within 3 years prior to enrollment.
History of systemic corticosteroids (e.g. an equivalent dose of prednisone of > 20 mg daily for > 14 days), immunosuppressive anti-cancer, interleukins, systemic interferons, systemic chemotherapy or other medications considered significant by the trial physician within the last 6 months.
Any clinically significant acute or chronic medical condition (e.g. such as autoimmune diseases, cirrhosis), other than HIV infection, that in the opinion of the investigator would preclude participation.
History of or current clinical atherosclerotic cardiovascular disease (ASCVD), as defined by 2013 ACC/AHA guidelines.
QTcF interval ≥ 440 ms at screening.
Any history of an HIV-associated malignancy, including Kaposi's sarcoma, or any type of lymphoma or virus-associated cancers.

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History of Progressive Multifocal Leukoencephalopathy (PML).
Active or recent non-HIV-associated malignancy requiring systemic chemotherapy or surgery in the preceding 36 months or for whom such therapies are expected in the subsequent 12 months;
Hepatitis B or C infection as indicated by the presence of Hepatitis B surface antigen (HBsAg) or hepatitis C virus RNA (HCV-RNA) in blood.
Participants with known hypersensitivity to any constituent of the investigational products.
Pregnancy or lactation.
ART initiated during acute infection (defined as p24, HIV NAAT, or HIV RNA PCR positive, and negative or indeterminate HIV antibody testing).
Receipt of cabotegravir-LA IM or rilpivirine-LA IM within 24 months prior to Step 1 study entry.
Known resistance to all drugs within two or more ARV drug classes.
Laboratory abnormalities in the parameters listed below:
Absolute neutrophil count < 1,000 cells/microlitre;
Hemoglobin < 10 gm/dL;
Platelet count < 100,000 cells/microlitre;
ALT > 1.5 x ULN;
AST > 1.5 x ULN;
Total bilirubin > 1.5 x ULN;
eGFR < 60 mL/min/1.73m2;
Any history of receipt of therapeutic HIV vaccine or HIV monoclonal antibody therapy.
Participation in any clinical study of an investigational product within 12 weeks prior to study entry (day 0) or expected participation in such a study during this study.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Weill Cornell Medicine, Cornell Clinical Trials Unit
New York, New York, 10021
The Rockefeller University
New York, New York, 10065
Perelman School of Medicine University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: An Open Label, Single Arm Study of the Safety and Antiretroviral Activity of Two Long-acting Broadly Neutralizing Antibodies Plus an IL-15 Superagonist in ART-treated Adults Living With HIV During Analytical Treatment Interruption

The proposed study is a phase 1, open label, single arm study to evaluate the safety and antiretroviral activity of the combination of two long-acting broadly neutralizing antibodies, 3BNC117-LS dosed once at 30 mg/kg and 10-1074-LS dosed once at 10 mg/kg, both intravenously (IV) at week 0, plus an IL-15 superagonist complex, N-803, dosed at 6 mcg/kg, subcutaneously (SC) at week 1 and then every 3 weeks for a total of 8 doses, in ART-treated adults living with HIV during analytical treatment interruption.

Read the detailed description

The proposed study is a phase 1, open label study of the safety and antiretroviral activity of the 3BNC117-LS plus 10-1074-LS broadly neutralizing antibody (bNAb) combination plus N-803, an IL-15 superagonist complex, in ART-treated individuals living with HIV during interruption of ART.

Thirty-six eligible participants will be enrolled sequentially and will be assigned to Group A or Group B after Monogram PhenoSense Assay results become available: Group A - participants with 3BNC117 and 10-1074 IC90 less or equal to 1 mcg/mL and MPI greater or equal to 98% by the Monogram PhenoSense assay using PBMCs; Group B - all other participants, including participants from whom the PhenoSense Assay (PBMC) does not yield a result.

Participants will discontinue ART on day 2 (2 days after the first antibody infusions) and will be followed for up to 72 weeks while off ART and for 12 weeks after ART is resumed.

Conditions: Human Immunodeficiency Virus
Being tested: 3BNC117-LS, 10-1074-LS, N803
Keywords: 3BNC117-LS, 10-1074-LS, Broadly Neutralizing Antibody, N-803, IL-15 superagonist complex
Medical subject headings: Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

3BNC117-LSDrug
Also called broadly neutralizing antibody, monoclonal antibody
Intravenous infusion of 3BNC117-LS at 30 mg/kg
10-1074-LSDrug
Also called broadly neutralizing antibody, monoclonal antibody
Intravenous infusion of 10-1074-LS at 10 mg/kg
N803Drug
Also called IL-15 superagonist complex
Subcutaneous injections of N803 at 6 mcg/kg

Study groups in NCT05245292
Study group	Role	What they receive
3BNC117-LS + 10-1074-LS + N-803	Experimental	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) Receives: Drug: 3BNC117-LS; Drug: 10-1074-LS; Drug: N803

What is being measured

The primary outcome is the main question the study is designed to answer.

Treatment-related Grade 3 adverse events and serious adverse events
The number of participants with treatment-related solicited and unsolicited grade 3 and serious adverse events (including confirmed laboratory abnormalities), or premature study treatment discontinuation due to an adverse event (regardless of grade).
Measured: 72 weeks
Any serious adverse events
The number of participants with serious adverse events, regardless of relationship to 3BNC117-LS, 10-1074-LS and N-803.
Measured: 72 weeks
Dosing completion
The proportion of participants who complete dosing with 3BNC117-LS, 10-1074-LS and N-803.
Measured: 24 weeks
Viral rebound before or at week 24 post withdrawing ART
The number of participants experiencing viral rebound, defined as confirmed HIV-1 RNA >200 copies/mL at or prior to week 24 of ART discontinuation.
Measured: 24 weeks
ART not restarted by weeks 60 and 72
The proportion of participants who do not meet ART restart criteria by weeks 60 and 72.
Measured: 72 weeks
ART not restarted when bNABs below threshold
The proportion of participants who do not meet ART restart criteria for 12 or more weeks after bNAbs are below a threshold of 10 mcg/ml.
Measured: 72 weeks

Secondary outcomes (8)

Treatment-related Grade 2 adverse events
The number of participants with treatment-related solicited and unsolicited grade 2 adverse events.
Measured: 72 weeks
Viral rebound through Step 2
The number of participants experiencing viral rebound, defined as confirmed HIV-1 RNA >200 copies/mL, through Step 2 of the study.
Measured: 72 weeks
Time from ART withdrawal to re-initiating ART
Time from ART withdrawal to virologic or immunologic criteria (i.e. viral load, CD4 cell count, or development of severe acute retroviral syndrome) to reinitiate ART.
Measured: 72 weeks
Viral rebound determined by Monogram assay
Time to viral rebound (confirmed HIV-1 RNA >200 copies/mL) across different 3BNC117-LS and 10-1074-LS IC90s cut points determined by the Monogram PhenoSense assay.
Measured: 72 weeks
Size of latent HIV-1 reservoir
Size of the latent HIV-1 reservoir, measured by IPDA and/or other appropriate assay, before, during (Step 1) and after dosing with 3BNC117-LS, 10-1074-LS and N-803 (Step 2), and after antibody concentrations have declined below a therapeutic threshold.
Measured: 72 weeks
Changes in HIV-1 specific T Cell immune responses
Changes in HIV-1 specific T cell immune responses in peripheral blood, measured by ELISPOT, before, during (Step 1) and after dosing with 3BNC117-LS, 10-1074-LS and N-803 (Step 2), and after antibody concentrations have declined below a therapeutic threshold.
Measured: 72 weeks
Half-life of 3BNC117-LS and 10-1074-LS
Half-life of 3BNC117-LS and 10-1074-LS, when administered in combination with N-803 to individuals with HIV during ART interruption.
Measured: 72 weeks
Anti-drug antibodies (ADA)
The proportion of individuals with treatment-induced ADA against each bNAb or N-803 and magnitude of the response.
Measured: 72 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Dec 202231 Dec 2025

First posted17 Feb 2022
Study start7 Dec 2022
Primary completion9 Dec 2025
Study completion31 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Human Immunodeficiency VirusStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05245292
Sponsor's protocol ID: MCA-1031 (ES38918)
Other IDs: 1U01AI145921
Status last verified: Dec 2025
First submitted: 8 Feb 2022
Last updated: 31 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Single Arm Study of the Safety and Antiretroviral Activity of Two Long-acting Broadly Neutralizing Antibodies Plus an IL-15 Superagonist in ART-treated Adults Living With HIV During Analytical Treatment Interruption
ClinicalTrials.gov ID: NCT05245292
Acronym / sponsor ID: MCA-1031 (ES38918)
Conditions: Human Immunodeficiency Virus
Keywords: 3BNC117-LS, 10-1074-LS, Broadly Neutralizing Antibody, N-803, IL-15 superagonist complex
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Rockefeller UniversityUniversity, hospital or other
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID), Weill Medical College of Cornell University, University of Pennsylvania
Study start: 7 Dec 2022 (actual)
Primary completion: 9 Dec 2025 (actual)
Study completion: 31 Dec 2025 (actual)
First posted: 17 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Participants will discontinue ART on day 2 (2 days after the first antibody infusions) and will be followed for up to 72 weeks while off ART and for 12 weeks after ART is resumed.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
3BNC117-LS + 10-1074-LS + N-803	Experimental	Drug: 3BNC117-LS, Drug: 10-1074-LS, Drug: N8033BNC117-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)

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Male and females, age 18 to 70.
Confirmed HIV-1 infection.
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.
NOTE: At least two Viral Load (VL) measurements within 48 weeks prior to the Step 0 screening visit must be available for review. A single plasma HIV-1 RNA > 50 copies/mL but < 200 copies/mL that is followed by an HIV-1 RNA <50 copies/mL is permitted.
Current CD4+ T cell counts > 450 cells/mcL, CD4+ T cell % ≥ 15%, and CD4+ T cell count nadir of ≥ 200 cells/mcL.

Key exclusion criteria (24 listed)

History of AIDS-defining illness within 3 years prior to enrollment.
History of systemic corticosteroids (e.g. an equivalent dose of prednisone of > 20 mg daily for > 14 days), immunosuppressive anti-cancer, interleukins, systemic interferons, systemic chemotherapy or other medications considered significant by the trial physician within the last 6 months.
Any clinically significant acute or chronic medical condition (e.g. such as autoimmune diseases, cirrhosis), other than HIV infection, that in the opinion of the investigator would preclude participation.
History of or current clinical atherosclerotic cardiovascular disease (ASCVD), as defined by 2013 ACC/AHA guidelines.
QTcF interval ≥ 440 ms at screening.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
3BNC117-LSAlso: broadly neutralizing antibody, monoclonal antibodyIntravenous infusion of 3BNC117-LS at 30 mg/kg	Drug	3BNC117-LS + 10-1074-LS + N-803
10-1074-LSAlso: broadly neutralizing antibody, monoclonal antibodyIntravenous infusion of 10-1074-LS at 10 mg/kg	Drug	3BNC117-LS + 10-1074-LS + N-803
N803Also: IL-15 superagonist complexSubcutaneous injections of N803 at 6 mcg/kg	Drug	3BNC117-LS + 10-1074-LS + N-803

Primary outcome

Treatment-related Grade 3 adverse events and serious adverse events
Time frame: 72 weeks
The number of participants with treatment-related solicited and unsolicited grade 3 and serious adverse events (including confirmed laboratory abnormalities), or premature study treatment discontinuation due to an adverse event (regardless of grade).
Any serious adverse events
Time frame: 72 weeks
The number of participants with serious adverse events, regardless of relationship to 3BNC117-LS, 10-1074-LS and N-803.
Dosing completion
Time frame: 24 weeks
The proportion of participants who complete dosing with 3BNC117-LS, 10-1074-LS and N-803.
Viral rebound before or at week 24 post withdrawing ART
Time frame: 24 weeks
The number of participants experiencing viral rebound, defined as confirmed HIV-1 RNA >200 copies/mL at or prior to week 24 of ART discontinuation.
ART not restarted by weeks 60 and 72
Time frame: 72 weeks
The proportion of participants who do not meet ART restart criteria by weeks 60 and 72.
ART not restarted when bNABs below threshold
Time frame: 72 weeks
The proportion of participants who do not meet ART restart criteria for 12 or more weeks after bNAbs are below a threshold of 10 mcg/ml.

8 secondary outcomes

Treatment-related Grade 2 adverse events
Time frame: 72 weeks
Viral rebound through Step 2
Time frame: 72 weeks
Time from ART withdrawal to re-initiating ART
Time frame: 72 weeks
Viral rebound determined by Monogram assay
Time frame: 72 weeks
Size of latent HIV-1 reservoir
Time frame: 72 weeks
Changes in HIV-1 specific T Cell immune responses
Time frame: 72 weeks
Half-life of 3BNC117-LS and 10-1074-LS
Time frame: 72 weeks
Anti-drug antibodies (ADA)
Time frame: 72 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Marina Caskey, MD principal investigator

The Rockefeller University

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing 3BNC117-LS, 10-1074-LS and N803 in people with Human Immunodeficiency Virus, run by Rockefeller University at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-related Grade 3 adverse events and serious adverse events (time frame: 72 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05245292.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2026.