A clinical trial investigating the safety and biological activity of the antibody BNT351 in adults living without and with HIV

Start 9 Feb 2026 · Status Ongoing, recruiting · 1 EU/EEA countries · 2 sites · Protocol BNT351-01

Overview

Sponsor-declared trial summary

Phase Human pharmacology (Phase I) - First administration to humans

Status Ongoing, recruiting

Participants planned 55

Countries 1

Sites 2

HIV-1 infection

Key facts

Sponsor: BioNTech SE
Participant type: Patients, Healthy volunteers
Age range: 18-64 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Virus Diseases [C02]
Trial duration: 9 Feb 2026 → ongoing
Decision date (initial): 2025-12-22
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Conditions and MedDRA coding

HIV-1 infection

Version	Level	Code	Term	System organ class
20.1	PT	10020161	HIV infection	100000004862

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

BioNTech SE

Sponsor organisation: BioNTech SE
Address: An Der Goldgrube 12, Oberstadt Oberstadt
City: Mainz
Postcode: 55131
Country: Germany

Scientific contact point

Organisation: BioNTech SE
Contact name: Clinical Trial Information Desk

Public contact point

Organisation: BioNTech SE
Contact name: Clinical Trial Information Desk

Locations

1 EU/EEA country · 2 investigational sites

By country

Country	MS status	Planned subjects	Sites
Germany	Ongoing, recruiting	55	2
Rest of world	—	0	—

Investigational sites

Germany

2 sites · Ongoing, recruiting

CRS Clinical Research Services Mannheim GmbH

Clinical Pharmacology Unit, Grenadierstrasse 1, Neckarstadt, Mannheim

Universitaetsklinikum Koeln AöR

Klinik für Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Germany	2026-02-09		2026-02-09

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2025-10-10	Germany	Acceptable 2025-12-19	2025-12-22
2	NON SUBSTANTIAL MODIFICATION	NSM-1	2026-01-20	Germany	Acceptable 2025-12-19	2026-01-20