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RecruitingNCT07392372Updated Sep 1, 2026

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

A Phase 1 interventional study of BNT351 and Placebo in HIV -1 Infection, sponsored by BioNTech SE. Recruiting at 6 sites in 2 countries. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by BioNTech SE · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Feb 2026; still recruiting 7 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
67
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • HIV -1 Infection

Keywords

  • HIV-1
  • Treatment of HIV-1 infection
  • Antibody
03

In context

Lead sponsor

BioNTech SE is the lead sponsor of 74 studies on the registry; 23 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 26 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria

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:

    1. 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.
    2. Agree to discuss HIV disease risks;
    3. Agree to HIV acquisition risk reduction counseling;

Part B:

  • Are HIV-1 positive and HIV-2 negative at Visit 0.

  • Individuals who at Visit 0:

    1. 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.
    2. 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.
    3. 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).
    4. 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.
    5. 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).
    6. Are willing to undergo HIV transmission risk reduction counseling and to maintain low-risk behavior to protect their partners.

Key Exclusion Criteria:

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.
  • 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.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
67 participants (estimated)

Study arms

  • Experimental
    Part A - Cohort A1

    PLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (2:1)

    Drug: BNT351 · Drug: Placebo

  • Experimental
    Part A - Cohort A2

    PLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (3:1)

    Drug: BNT351 · Drug: Placebo

  • Experimental
    Part A - Cohort A3

    PLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (3:1)

    Drug: BNT351 · Drug: Placebo

  • Experimental
    Part A - Cohort A4

    PLWOH will be randomized to BNT351 (at a protocol defined dose level) or placebo (3:1)

    Drug: BNT351 · Drug: Placebo

  • Experimental
    Part B - Cohort B1

    PLWH will receive BNT351 at a protocol-defined dose level. cART will start 56 days post-BNT351 dosing or earlier.

    Drug: BNT351

  • Experimental
    Part B - Cohort B2

    PLWH will receive BNT351 at a protocol-defined dose level. cART will start 56 days post-BNT351 dosing or earlier.

    Drug: BNT351

Interventions

  • DrugBNT351

    IV infusion

  • DrugPlacebo

    IV infusion

  • DrugBNT351

    SC injection

  • DrugPlacebo

    SC injection

06

What researchers measure

Primary outcomes

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

    Per part, by cohort/dose

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: From dosing through 7 days post-dose

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

    Per part, by cohort/dose

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

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

Secondary outcomes

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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

07

Study locations

5 of 6 sites recruiting
  • Cook County Health
    Chicago, Illinois 60612, United States
    Recruiting
  • Johns Hopkins
    Baltimore, Maryland 21205-1832, United States
    Recruiting
  • Washington University
    St Louis, Missouri 63110, United States
    Recruiting
  • Columbia University
    New York, New York 10032, United States
    Recruiting
  • UK Köln
    Cologne, 50937, Germany
    Recruiting
  • CRS Mannheim
    Mannheim, 68167, Germany
    Active, not recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07392372
Lead sponsor
BioNTech SE
Responsible party
Sponsor
First posted
Feb 6, 2026
Start date
Feb 9, 2026
Primary completion
Nov 2026 (estimated)
Completion
Jun 2027 (estimated)
Last update
Sep 1, 2026

Study contacts

BioNTech clinical trials patient information
Contact
patients@biontech.de
+49 6131 9084 ext. 0
BioNTech Response Person
study director · BioNTech SE

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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