RecruitingPhase 1

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

United States, Germany61 participantsStarted 2026-02-09

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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;
✓. 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 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 ≥400 cells/µL and plasma HIV-1 RNA levels between 1,000-100,000 copies/mL at screening.
✓

What they're measuring

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

Timeframe: From dosing to 56 days post-dose

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

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

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

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

Timeframe: From dosing through 7 days post-dose

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

Timeframe: From dosing through 7 days post-dose

Parts A and B- Assessment of area under the concentration-time curve of BNT351

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

Trial details

NCT IDNCT07392372

SponsorBioNTech SE

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06

Contact for this trial

BioNTech clinical trials patient information

+49 6131 9084 patients@biontech.de

View on ClinicalTrials.gov More HIV -1 Infection trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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;
✓. 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 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 ≥400 cells/µL and plasma HIV-1 RNA levels between 1,000-100,000 copies/mL at screening.
✓

What they're measuring

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

Timeframe: From dosing to 56 days post-dose

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

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

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

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

Timeframe: From dosing through 7 days post-dose

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

Timeframe: From dosing through 7 days post-dose

Parts A and B- Assessment of area under the concentration-time curve of BNT351

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