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

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.

Timeline

Start

2026-02-09

Primary completion

2026-11

Completion

2027-06

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.

Drugs

Indications