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HIV InfectionPhase 1NCT06585891

Study of a Human Bispecific Antibody VRC-HIVMAB0121-00-AB (CAP256J3LS) Administered Intravenously or Subcutaneously to Healthy Adults

A Phase 1 study testing VRC-HIVMAB0121-00-AB in people with HIV Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site 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

Background: HIV (human immunodeficiency virus) is the virus that causes AIDS (acquired immunodeficiency syndrome). Researchers want to find new ways to treat or prevent HIV infection. CAP256J3LS is a new product that uses antibodies. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
HIV Infection
What is being tested?
VRC-HIVMAB0121-00-AB
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteUnited States
Study dates
7 Oct 2024to 30 Sep 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 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • A participant must meet all of the following criteria:
  • Willing and able to complete the informed consent process.
  • Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
  • Available for clinical follow-up through the last study visit.
  • 18 to 60 years of age.
  • In good general health without a clinically significant medical history.
Show all 24Show fewer
  • Physical examination without clinically significant findings within the 56 days prior to enrollment.
  • Adequate venous access if assigned to an IV group or adequate abdominal subcutaneous tissue if assigned to a SC group.
  • Willing to have blood samples collected, stored indefinitely, and used for research purposes.
  • Laboratory Criteria within 56 days prior to enrollment:
  • White blood cell count (WBC): 2,500-12,000/mm^3.
  • WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval, excluding absolute lymphocyte count which must not be lower than normal range.
  • Platelets: 125,000 - 400,000/mm^3.
  • Hemoglobin within institutional normal range or is lower than normal range but does not meet Grade 1 criteria and is not clinically concerning.
  • Creatinine: <= 1.1 x Upper Limit of Normal (ULN).
  • ALT: <= ULN.
  • AST: <= ULN.
  • ALP: <= ULN.
  • Total bilirubin within institutional normal range or is outside normal range but does not meet Grade 1 criteria and is not clinically concerning
  • Direct bilirubin: <= ULN
  • Negative HIV 1/2 Antibody/Ag test.
  • Female-Specific Criteria:
  • Agrees to use an effective means of birth control from 21 days prior to enrollment through the duration of study participation.
  • Negative beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.

Who cannot join

  • A participant will be excluded if one or more of the following conditions apply:
  • Woman who is breast-feeding or planning to become pregnant during study participation.
  • Weight > 115 kg.
  • Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis prior to enrollment that has a reasonable risk of recurrence during the study.
  • Hypertension that is not well controlled.
  • Receipt of any investigational study product within 28 days prior to enrollment.
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  • Receipt of an investigational HIV vaccine or anti-HIV monoclonal antibody.
  • Receipt of any live attenuated vaccine within 28 days prior to enrollment.
  • Receipt of any vaccine within 2 weeks prior to enrollment.
  • Known history of Gilbert's syndrome.
  • Known history of kidney or liver disease.
  • Diabetes mellitus (type I or II), with the exception of a history of gestational diabetes.
  • More than 10 days of systemic immunosuppressive medications or cytotoxic medications within the 4 weeks prior to enrollment or any within 14 days prior to enrollment.
  • Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws.
  • Any other chronic or clinically significant medical condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer, including but not limited to diabetes mellitus, hepatitis, asthma, infectious disease, autoimmune disease, psychiatric disorder, heart disease, cancer and clinically significant forms of drug or alcohol abuse.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: VRC 617: A Phase 1, Open-Label, Dose-Escalation Study to Evaluate Safety and Pharmacokinetics of a Human Bispecific Antibody, VRC-HIVMAB0121-00-AB (CAP256J3LS) Administered Intravenously or Subcutaneously to Healthy Adults

Background:

HIV (human immunodeficiency virus) is the virus that causes AIDS (acquired immunodeficiency syndrome). Researchers want to find new ways to treat or prevent HIV infection. CAP256J3LS is a new product that uses antibodies. Antibodies are naturally occurring proteins; they target and disable disease-causing agents such as viruses. This new product may be able to stop HIV infections.

Read more

Objective:

To test the safety of CAP256J3LS in healthy people.

Eligibility:

People aged 18 to 60 years in good general health.

Design:

CAP256J3LS can be administered in 2 ways: (1) by a shot under the skin into the belly fat or (2) through a tube inserted into a vein in the arm. Participants will be divided into 6 groups: The study will open with the lowest dose of study product. The dose groups are spaced out to allow the study team to look over the safety data in each group. If there are no safety concerns in the lowest dose, then the next higher dose groups will be enrolled. This pattern will continue until all dose groups are enrolled.. Also, some participants will receive only 1 dose; others will receive 3 doses, each spaced 12 weeks apart.

Those who receive only 1 dose of the study drug will have 14 clinic visits over 6 months. Those who get 3 doses will have 27 visits over 11 months. Participants will provide blood samples at each visit. Urine samples may also be needed.

All participants will get a thermometer and a measuring tool. They will measure any redness, swelling, or bruising they have at the injection site. They will check their temperature every day for 7 days after receiving the study drug. They will record their highest temperatures and any symptoms they have.

...

Read the detailed description

Design:

This first-in-human, Phase 1, open-label study will examine safety, tolerability, dose, and pharmacokinetics (PK) of CAP256J3LS (VRC-HIVMAB0121-00-AB) in healthy adults in a dose-escalation design. The primary hypothesis is that subcutaneous (SC) and intravenous (IV) administrations of CAP256J3LS will be safe and well-tolerated in healthy adults. A secondary hypothesis is that CAP256J3LS will be detectable in human sera with a definable half-life.

Study Products:

The CAP256J3LS bispecific antibody (bsAb) targets the V2-apex and CD4-binding sites of the HIV-1 envelope. It is composed of the J3 camelid nanobody linked to CAP256V2LS through a 15 amino acid linker arm attached to the N-terminus of the CAP256V2LS light chain. The addition of the J3 nanobody adds a CD4-binding site directed neutralization functionality to the CAP256V2LS, which targets the V2 region of the HIV Env trimer. The bispecific antibody was developed by the VRC/NIAID/NIH and is manufactured under cGMP regulations at the VRC Pilot Plant operated under contract by the Vaccine Clinical Materials Program (VCMP), Leidos Biomedical Research, Inc., Frederick. MD.

Participants:

Healthy adults, 18-60 years of age

Study Plan:

This open-label study will include 6 groups to evaluate CAP256J3LS administered one time or by repeat dosing. Enrollment will begin with the 5 mg/kg dose groups, and enrollment for subsequent dose groups will proceed after dose-escalation safety reviews. Assessment of safety will include solicited reactogenicity and other adverse events, clinical observations, and monitoring of hematological and chemistry parameters at clinical visits throughout the study.

Conditions
HIV Infection
Being tested
VRC-HIVMAB0121-00-AB
Keywords
Immune Response, HIV, Bi-Specific Antibody
Medical subject headings
HIV Infections

What participants receive

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

  • VRC-HIVMAB0121-00-ABBiological

    The CAP256J3LS bispecific antibody (bsAbs) targets the V2-apex and CD4-binding sites of the HIV-1 envelope. It is composed of the light chain of CAP256V2LS, linked to the llama nanobody J3, which has broad CD4-binding site-directed neutralization.

Study groups in NCT06585891
Study groupRoleWhat they receive
Group 1Experimental5 mg/kg IV- single administration
Receives: Biological: VRC-HIVMAB0121-00-AB
Group 2Experimental5 mg/kg SC- single administration
Receives: Biological: VRC-HIVMAB0121-00-AB
Group 3Experimental20 mg/kg IV- single administration
Receives: Biological: VRC-HIVMAB0121-00-AB
Group 4Experimental40 mg/kg IV- single administration
Receives: Biological: VRC-HIVMAB0121-00-AB
Group 5Experimental5 mg/kg SC- repeat dosing
Receives: Biological: VRC-HIVMAB0121-00-AB
Group 6Experimental20 mg/kg IV-repeat dosing
Receives: Biological: VRC-HIVMAB0121-00-AB

What is being measured

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

  1. Safety and tolerability of CAP256J3LS (5 mg/kg SC) administered to healthy adults

    To evaluate the safety and tolerability of a single SC dose

    Measured: Through 24 weeks after product administration

  2. Safety and tolerability of CAP256J3LS ( 5mg/kg or 20mg/kg or 40 mg/kg IV) administered to healthy adults

    To evaluate the safety and tolerability of a single IV dose

    Measured: Through 24 weeks after product administration

  3. Safety and tolerability of CAP256J3LS ( 5 mg/kg SC) administered for for a total of 3 injections in 12 week intervals to healthy adults

    To evaluate the safety and tolerability of a repeat SC dosing

    Measured: Through 24 weeks after last product administration

  4. Safety and tolerability of CAP256J3LS ( 20 mg/kg IV) administered for for a total of 3 injections in 12 week intervals to healthy adults

    To evaluate the safety and tolerability of a repeat IV dosing

    Measured: Through 24 weeks after last product administration

Secondary outcomes (1)

  1. PK will be evaluated at each dose level and route of administration

    To evaluate the pharmacokinetics of CAP256J3LS

    Measured: Throughout the study

Timeline

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

  1. First posted19 Sep 2024
  2. Study start7 Oct 2024
  3. Primary completion30 Sep 2025
  4. Study completion30 Sep 2025

Resources

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
Prevention
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06585891
Sponsor's protocol ID
10001965
Other IDs
001965-I
Status last verified
19 Mar 2026
First submitted
5 Sep 2024
Last updated
23 Mar 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang B, Gorman J, Kwon YD, Pegu A, Chao CW, Liu T, Asokan M, Bender MF, Bylund T, Damron L, Gollapudi D, Lei P, Li Y, Liu C, Louder MK, McKee K, Olia AS, Rawi R, Schon A, Wang S, Yang ES, Yang Y, Carlton K, Doria-Rose NA, Shapiro L, Seaman MS, Mascola JR, Kwong PD. Bispecific antibody CAP256.J3LS targets V2-apex and CD4-binding sites with high breadth and potency. MAbs. 2023 Jan-Dec;15(1):2165390. doi: 10.1080/19420862.2023.2165390.

    PubMed 36729903

  • McCoy LE, Quigley AF, Strokappe NM, Bulmer-Thomas B, Seaman MS, Mortier D, Rutten L, Chander N, Edwards CJ, Ketteler R, Davis D, Verrips T, Weiss RA. Potent and broad neutralization of HIV-1 by a llama antibody elicited by immunization. J Exp Med. 2012 Jun 4;209(6):1091-103. doi: 10.1084/jem.20112655. Epub 2012 May 28.

    PubMed 22641382

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VRC-HIVMAB0121-00-AB in people with HIV Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site 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 24 inclusion and 15 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 23 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 1 site 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?

Safety and tolerability of CAP256J3LS (5 mg/kg SC) administered to healthy adults (time frame: Through 24 weeks after product administration). The study lists 4 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 NCT06585891, which also lists 2 linked publications.

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 23 Mar 2026.

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