BNT351 for HIV-1 Infection
This study is looking at an investigational antibody called BNT351. It aims to understand how safe BNT351 is and what side effects it might cause in adults both with and without HIV. Researchers will also measure how much BNT351 stays in the blood over time. For people living with HIV who have detectable virus, the study will also check if BNT351 can reduce the amount of HIV in their blood. You could be eligible if you are between 18 and 65 years old. The main goals are to learn about safety, how the body handles BNT351, and its potential anti-viral effects. The study is currently recruiting 67 participants.
- Study design
- This is an interventional study with 67 planned participants. It includes both randomized, double-blind, placebo-controlled parts and open-label parts, testing BNT351 given intravenously (IV) or as a subcutaneous (SC) injection.
- What's involved
- For Part A, you would have about a 4-week screening period, receive one dose of BNT351 or placebo, and then have about 38 weeks of follow-up. The total time commitment for Part A is up to 42 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for safety and side effects from the time of dosing up to 56 days post-dose. For Part A, there is an approximate 38-week follow-up period after dosing.
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NCT07392372
A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV
Recruiting
PHASE1Ages 18–65InterventionalTreatmentBioNTech SE
~67 participants
Updated 2026-08-12 on ClinicalTrials.gov
What's tested:BNT351Placebo
At a glance
Recruiting sites
4 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Parts A and B - Occurrence of at least one adverse event (AE)
Measured over From dosing to 56 days post-dose
+11 more outcomes measured
Conditions
Where it's being run
6 sites across 5 statesGermany2
Illinois1
Maryland1
Missouri1
New York1
Study leadership
- BioNTech Response Person · STUDY_DIRECTOR · BioNTech SE
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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 HIV-1 positive and HIV-2 negative at Visit 0.
Individuals who at Visit 0:
Exclusion
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.
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.
What this trial measures
- Parts A and B - Occurrence of at least one adverse event (AE)From dosing to 56 days post-dose
Per part, by cohort/dose
- Parts A and B - Occurrence of at least one serious AE (SAE)From dosing to 56 days post-dose
Per part, by cohort/dose
- 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)From the start of IV dosing through 72 hours after the start of IV dosing
Per part, by cohort/dose
- Parts A and B - Occurrence of at least one solicited local reaction (pain/tenderness, erythema/redness, induration/swelling) at the investigational medicinal product administration siteFrom dosing through 7 days post-dose
Per part, by cohort/dose
- Parts A and B- Occurrence of at least one solicited systemic event (vomiting, diarrhea, headache, fatigue/malaise, myalgia/arthralgia, fever)From dosing through 7 days post-dose
Per part, by cohort/dose
- Parts A and B - Assessment of maximum concentration of BNT351From dosing through 7 days post-dose
Per part, by cohort/dose
- Part B - Occurrence of any acquired immunodeficiency syndrome (AIDS)-defining illness or opportunistic infection as defined in the protocolFrom dosing up to the time of cART initiation (up to a maximum of 56 days post-dose)
- Part B - Occurrence of absolute CD4+ T cell count <350 cells/µL or CD4+ T cell count <15% of total lymphocyte countFrom dosing up to the time of cART initiation (up to a maximum of 56 days post-dose)
- Part B - Change from baseline in HIV log10 plasma viral load prior to cART initiationAt 7, 14, 21, 28, 35, 42, 49, and 56 days post-dose
- Part B - Maximum decrease from baseline in HIV log10 plasma viral load prior to cART initiationFrom baseline up to the time of cART initiation (up to a maximum of 56 days post-dose)
- Part B - Time from dosing to lowest viral load prior to cART initiationFrom dosing up to the time of cART initiation (up to a maximum of 56 days post-dose)
- 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)From dosing up to the time of cART initiation (up to a maximum of 56 days post-dose)