AzTrials
AzTrials

HIV -1 InfectionPhase 1NCT07392372

A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV

A Phase 1 study testing BNT351 in people with HIV -1 Infection, run by BioNTech SE at 6 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This study will test the safety and blood levels of the antibody BNT351 in people living without and with human immunodeficiency virus (HIV). This study will also test the anti-viral activity of BNT351 in people living with HIV (PLWH) with detectable virus levels. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
HIV -1 Infection
What is being tested?
BNT351
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
67 participants
Where
6 sitesin 2 countries
Study dates
9 Feb 2026to Jun 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Part A:
  • Are HIV-1 and HIV-2 negative at Visit 0.
  • Starting at Visit 0 and continuously until the last planned visit in this study are individuals who:
  • Are assessed by the investigator as having a low likelihood of acquiring HIV and are committed to avoiding behaviors associated with a higher likelihood of acquiring HIV until the End of Study Visit.
  • Agree to discuss HIV disease risks;
  • Agree to HIV acquisition risk reduction counseling;
Show all 15Show fewer
  • Part B:
  • Are HIV-1 positive and HIV-2 negative at Visit 0.
  • Individuals who at Visit 0:
  • Are cART-naïve individuals who were diagnosed with HIV-1 infection ≤12 months prior to screening, OR are individuals who have discontinued cART and who were diagnosed with HIV-1 infection ≤12 months prior to screening or ≤18 months if this is found to be acceptable after discussion on a case-by-case basis with the sponsor's medical monitor.
  • If cART-experienced, have discontinued cART for at least 4 weeks before screening (if the individual was taking long-acting antiretroviral therapy [ART]), see the following bullet). For individuals who have discontinued cART: Are able to comply with study procedures and assessments in the investigator's judgment.
  • Have never received lenacapavir or ibalizumab or fostemsavir, and have not received other long-acting ARTs in the last 6 months (i.e., intramuscular cabotegravir, cabotegravir-rilpivirine).
  • Have a CD4+ T cell count of ≥500 cells/µL and plasma HIV-1 RNA levels between 5,000-100,000 copies/mL at screening.
  • Are willing to initiate cART at a protocol-defined timepoint (56 days post-dose, or earlier if meeting early cART start criteria or at investigator's discretion).
  • Are willing to undergo HIV transmission risk reduction counseling and to maintain low-risk behavior to protect their partners.

Who cannot join

  • Parts A and B:
  • Have received an HIV vaccination or HIV broadly neutralizing antibody in another clinical study.
  • Have a known or suspected impairment/alteration of immune function or immunodeficiency (except for HIV infection, applicable to Part B only), including receipt of any immunostimulant, immunomodulator, immunosuppressive medication, immunoglobulin, blood product, or oral or parenteral steroid within 60 days prior to Day 1 or planned administration during the study. The following exception applies: Use of inhaled, intranasal, topical, or locally injected corticosteroids (e.g., intraarticular or intrabursal administration) is allowed.
  • Have a history of generalized urticaria or angioedema, or of allergy, anaphylaxis, hypersensitivity or intolerance to a human or humanized antibody or to BNT351 excipients.
  • Part B only:
  • Are receiving ongoing therapy for Mycobacterium tuberculosis infection.
Show all 10Show fewer
  • Have a history of opportunistic infections/AIDS-defining illnesses as defined in the protocol.
  • Have a history of multi-class drug resistant HIV-1 infection defined as resistance to three or more classes of HIV drugs.
  • Have a history of malignancy within 5 years before screening. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or a malignancy which is considered in the investigator's judgment to have minimal risk of recurrence. Any malignancy that is an AIDS-defining illness (as defined in the protocol) is exclusionary regardless of the perceived risk of recurrence.
  • NOTE: Other protocol defined inclusion/exclusion criteria apply.

Trial locations and contacts

6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

BioNTech clinical trials patient information contact

+49 6131 9084 ext. 0

patients@biontech.de

6 sites in 2 countries

United States4 sites, 4 recruiting

  • Johns Hopkins

    Baltimore, Maryland, 21205-1832

    Recruiting

  • Cook County Health

    Chicago, Illinois, 60612

    Recruiting

  • Columbia University

    New York, New York, 10032

    Recruiting

  • Washington University

    St Louis, Missouri, 63110

    Recruiting

Other trials in United States

Germany2 sites, 1 recruiting

  • UK Köln

    Cologne, 50937

    Recruiting

  • CRS Mannheim

    Mannheim, 68167

    Active, not recruiting

Other trials in Germany

About this study

Official title: A Phase I First-in-human Clinical Trial to Evaluate the Safety, Pharmacokinetics, and Antiviral Activity of the Broadly Neutralizing Antibody BNT351 in Adults Living Without and With HIV

This study will test the safety and blood levels of the antibody BNT351 in people living without and with human immunodeficiency virus (HIV). This study will also test the anti-viral activity of BNT351 in people living with HIV (PLWH) with detectable virus levels.

The main goals of this study are:

  • To learn about the safety of BNT351 and check for side effects.
  • To measure the amount of BNT351 antibody in blood over time.
  • To test the amount of HIV in the blood at different times after treatment with BNT351 in people living with HIV.
Read the detailed description

The study will consist of two parts (Parts A and B).

Part A will be a randomized, double-blind, placebo-controlled, single ascending dose, first-in-human study part. Part A will enroll people living without HIV (PLWOH). Four cohorts are planned in Part A (Cohorts A1, A2, A3, and A4). Cohort A1 will evaluate one dose of BNT351 administered subcutaneously (SC). Cohorts A2 to A4 will evaluate three different doses of BNT351 administered intravenously (IV). For each cohort, participants will be randomized to BNT351 or placebo.

Part B will be single-dose, open-label, proof-of concept study part. Part B will enroll PLWH. Part B comprises two cohorts (Cohorts B1 and B2) and will be non-randomized.

Parts A and B will use a sentinel participant/staggered dosing approach in which dosing will start with a lower dose of BNT351 and then progress to the next dose level.

The study will start with recruitment into Part A. Depending on the available safety, pharmacokinetics, and/or viral kinetics data generated within this study, any of the Part A or B cohorts may not be initiated or may be terminated earlier by sponsor decision.

In Part A, for each participant, there will be an ~4-week screening period, one dose of BNT351 or placebo, and an ~38-week follow-up period. In total, Part A will last up to ~42 weeks per participant.

In Part B, for each participant, there will be an ~4-week screening period, one dose of BNT351, and an up to 8-week observation period with HIV viral load assessments, after which combination antiretroviral therapy (cART) will be started. Overall, participants will be followed for ~38 weeks after IMP administration and in total, Part B will last up to ~42 weeks per participant.

Being tested
BNT351, Placebo
Keywords
HIV-1, Treatment of HIV-1 infection, Antibody

What participants receive

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

  • BNT351Drug

    IV infusion

  • PlaceboDrug

    IV infusion

  • BNT351Drug

    SC injection

  • PlaceboDrug

    SC injection

Study groups in NCT07392372
Study groupRoleWhat they receive
Part A - Cohort A1ExperimentalPLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (2:1)
Receives: Drug: BNT351; Drug: Placebo
Part A - Cohort A2ExperimentalPLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (3:1)
Receives: Drug: BNT351; Drug: Placebo
Part A - Cohort A3ExperimentalPLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (3:1)
Receives: Drug: BNT351; Drug: Placebo
Part A - Cohort A4ExperimentalPLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (3:1)
Receives: Drug: BNT351; Drug: Placebo
Part B - Cohort B1ExperimentalPLWH will receive BNT351 at a protocol-defined dose level. cART will start 56 days post-BNT351 dosing or earlier.
Receives: Drug: BNT351
Part B - Cohort B2ExperimentalPLWH will receive BNT351 at a protocol-defined dose level. cART will start 56 days post-BNT351 dosing or earlier.
Receives: Drug: BNT351

What is being measured

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

  1. Parts A and B - Occurrence of at least one adverse event (AE)

    Per part, by cohort/dose

    Measured: From dosing to 56 days post-dose

  2. Parts A and B - Occurrence of at least one serious AE (SAE)

    Per part, by cohort/dose

    Measured: From dosing to 56 days post-dose

  3. Parts A and B (except for Cohort A1) - Occurrence of infusion-related reactions (IRRs) Grade ≥2 (graded based on National Cancer Institute Common Terminology Criteria for AEs [NCI CTCAE] version 5.0 as specified in the protocol)

    Per part, by cohort/dose

    Measured: From the start of IV dosing through 72 hours after the start of IV dosing

  4. Parts A and B - Occurrence of at least one solicited local reaction (pain/tenderness, erythema/redness, induration/swelling) at the investigational medicinal product administration site

    Per part, by cohort/dose

    Measured: From dosing through 7 days post-dose

  5. Parts A and B- Occurrence of at least one solicited systemic event (vomiting, diarrhea, headache, fatigue/malaise, myalgia/arthralgia, fever)

    Per part, by cohort/dose

    Measured: From dosing through 7 days post-dose

  6. Parts A and B - Assessment of maximum concentration of BNT351

    Per part, by cohort/dose

    Measured: From dosing through 7 days post-dose

  7. Part B - Occurrence of any acquired immunodeficiency syndrome (AIDS)-defining illness or opportunistic infection as defined in the protocol

    Measured: From dosing up to the time of cART initiation (up to a maximum of 56 days post-dose)

  8. Part B - Occurrence of absolute CD4+ T cell count <350 cells/µL or CD4+ T cell count <15% of total lymphocyte count

    Measured: From dosing up to the time of cART initiation (up to a maximum of 56 days post-dose)

  9. Part B - Change from baseline in HIV log10 plasma viral load prior to cART initiation

    Measured: At 7, 14, 21, 28, 35, 42, 49, and 56 days post-dose

  10. Part B - Maximum decrease from baseline in HIV log10 plasma viral load prior to cART initiation

    Measured: From baseline up to the time of cART initiation (up to a maximum of 56 days post-dose)

  11. Part B - Time from dosing to lowest viral load prior to cART initiation

    Measured: From dosing up to the time of cART initiation (up to a maximum of 56 days post-dose)

  12. Part B - Time from dosing to viral rebound defined as HIV-1 RNA viral load increase >0.75 log10 copies/mL from nadir (i.e., lowest HIV-1 RNA viral load from 7 days post-dose (Visit 3) and through pre-cART initiation)

    Measured: From dosing up to the time of cART initiation (up to a maximum of 56 days post-dose)

Secondary outcomes (5)

  1. Parts A and B - Occurrence of at least one serious adverse event (SAE)

    Measured: From dosing through end of study (up to a maximum of 279 days post-dose)

  2. Parts A and B - Assessment of area under the concentration-time curve of BNT351, from pre-dose to last quantifiable timepoint (AUClast)

    Measured: From pre-dose to last quantifiable timepoint (up to a maximum of 279 days post-dose)

  3. Parts A and B - Incidence of detectable BNT351 anti-drug antibodies in serum

    Per part, by cohort/dose

    Measured: From baseline until the end of study (up to a maximum of 279 days post-dose)

  4. Part B - Magnitude of cluster of differentiation 4 positive (CD4+) T cell counts

    Measured: At dosing, 28 and 56 days post-dose or at time of cART initiation (up to a maximum of 56 days post-dose)

  5. Parts B - Change from baseline in CD4+ T cell count

    Measured: At 28 days post-dose and at time of cART initiation (up to a maximum of 56 days post-dose)

Timeline

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

  1. First posted6 Feb 2026
  2. Study start9 Feb 2026
  3. Primary completionNov 2026 (estimated)
  4. Study completionJun 2027 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
67 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07392372
Sponsor's protocol ID
BNT351-01
Other IDs
2025-523846-29-00, 2025
Status last verified
Aug 2026
First submitted
30 Jan 2026
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kratochvil S, Kullmann M, Gruell H, Sayettat S, Tsai CH, Vukovic N, Janaitis C, Lindemann C, Prassl S, Stumpf R, Knufer J, Tolksdorf F, Sahin U, Nelke J, Malz A, Schommers P, Bhebhe S, Mkhize N, Moore P, Seaman MS, Klein F, Le Douce V. Preclinical assessment of broadly neutralizing HIV-1 antibody BNT351 with optimized pharmacokinetics and potent antiviral activity. iScience. 2026 Jun 11;29(6):116022. doi: 10.1016/j.isci.2026.116022. eCollection 2026 Jun 19.

    PubMed 42325270

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BNT351 in people with HIV -1 Infection, run by BioNTech SE at 6 sites in 2 countries.

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 15 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Germany. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact BioNTech clinical trials patient information (+49 6131 9084 ext. 0, patients@biontech.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parts A and B - Occurrence of at least one adverse event (AE) (time frame: From dosing to 56 days post-dose). The study lists 12 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 NCT07392372, which also lists 1 linked publication.

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 1 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in