A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and With HIV
← catalyst calendarNCT07392372 · readout ≤ 103 d
Sponsored by BioNTech SE (industry) · BNTX — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
67estimated
Sites
6
Countries
Germany, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2026-02-09 | actual | When the study began enrolling |
| Primary completion | Nov 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jun 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2026-02-06 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-12 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- HIV -1 Infection
Interventions
- Drug: BNT351
- Drug: Placebo
- Drug: BNT351
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFParts A and B - Occurrence of at least one adverse event (AE)
measured From dosing to 56 days post-dose
Parts A and B - Occurrence of at least one serious AE (SAE)
measured From dosing to 56 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)
measured 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
measured 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)
measured From dosing through 7 days post-dose
Parts A and B - Assessment of maximum concentration of BNT351
measured From dosing through 7 days post-dose
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)
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)
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
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)
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)
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)
Publications
- PMID 42325270 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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