Updated June 2026 · ClinicalTrials.gov
BioNTech SE
4 clinical trials · 4 recruiting · INDUSTRY
BioNTech SE has 4 clinical trials registered on ClinicalTrials.gov, with 4 actively recruiting participants. The trials listed below cover 4 conditions across the phases listed in the sidebar. Always discuss any specific trial with your physician before contacting a study site.
About BioNTech SE\'s Trial Portfolio
BioNTech SE is an industry sponsor — typically a pharmaceutical, biotechnology, or medical device company. Industry sponsors fund and run the largest share of registered trials in the United States and are subject to FDA registration requirements under the FDA Amendments Act (FDAAA 801) for most drug and device studies.
4 of BioNTech SE's 4 registered trials are currently recruiting — roughly 100% of the portfolio. A high recruiting share usually points to an active research pipeline with multiple programs at the enrollment stage.
BioNTech SE's research footprint spans Metastatic Colorectal Cancer (1 trials), Recurrent Glioblastoma (1), and Non Small Cell Lung Cancer (1) as the top three conditions. The full condition list, sorted by trial count, is in the sidebar.
BioNTech SE's portfolio is weighted toward early-stage research — Phase 1 accounts for 50% of registered trials. Early-phase studies focus on safety, dosing, and pharmacokinetics in smaller groups, often the first time a treatment is tested in humans.
Trials by BioNTech SE
A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another...
This randomized, multi-site, three-part study will test a new treatment called BNT314, which is designed to help the body's immune system fight cancer in combination with another...
A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients...
This multi-site Phase II study will enroll adults with histologically confirmed diagnosis of World Health Organization (WHO) Grade IV glioblastoma (GBM), isocitrate dehydrogenase...
Clinical Trial Evaluating the Safety, Tolerability and Preliminary Efficacy of BNT116 Alone and in Combinations in...
This first-in-human (FIH) study for BNT116 aims to establish the safety profile and a safe dose for BNT116 monotherapy as well as for BNT116 in combination with approved medicinal...
A Clinical Trial Investigating the Safety and Biological Activity of the Antibody BNT351 in Adults Living Without and...
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...
How to Approach a Trial Listing
Each trial card above links to a dedicated page with the official ClinicalTrials.gov data plus a plain-English translation of the eligibility criteria. We translate technical terminology (ECOG performance status, hepatic function values, exclusionary lab thresholds) into language that a patient or caregiver can understand, but the original clinical text and the live ClinicalTrials.gov record always govern any actual eligibility decision.
Before contacting a trial site, write down questions for your treating physician using the framework on our 25 Questions guide. Discuss whether the trial fits your treatment plan, what the time commitment looks like, and whether your insurance will cover the standard-of-care portions. Trials are not a substitute for a treatment plan — they are an addition that needs medical guidance to evaluate.
Authoritative Resources
Verify any trial registration directly on ClinicalTrials.gov. For background on the FDA approval pathway that Phase 3 trials feed into, see the FDA drug approval process. For cancer-specific trial guidance, the National Cancer Institute publishes patient-oriented overviews. For global trial registrations beyond the U.S., the WHO ICTRP aggregates registries from around the world.
Frequently Asked Questions
How many clinical trials does BioNTech SE have on ClinicalTrials.gov?
BioNTech SE has 4 clinical trials registered on the federal ClinicalTrials.gov registry, of which 4 are actively recruiting participants right now. These counts come directly from the ClinicalTrials.gov API and are updated as the registry changes.
What conditions does BioNTech SE study?
BioNTech SE's registered trials cover 4 conditions on ClinicalTrials.gov, led by Metastatic Colorectal Cancer (1 trial), Recurrent Glioblastoma (1 trial), Non Small Cell Lung Cancer (1 trial), HIV-1-infection (1 trial). The complete condition list appears in the sidebar of this page; each condition links to a page listing every recruiting trial in that area, regardless of sponsor.
How do I join a BioNTech SE clinical trial?
Joining a clinical trial is a medical decision that should always involve your treating physician. Each trial page on this site includes the eligibility criteria translated into plain English alongside the official clinical text, plus the contact information that the sponsor has registered with ClinicalTrials.gov. Bring the trial information to your doctor before reaching out — they can review the full inclusion and exclusion criteria against your medical history and help you decide whether to pursue screening.
What does the trial phase mean?
Phase 1 trials test safety and dosing in small groups (often 20–80 healthy volunteers or patients). Phase 2 trials evaluate efficacy and side effects in larger groups (100–300 patients with the target condition). Phase 3 trials confirm efficacy and monitor safety in the largest groups (300–3,000+ patients) and form the basis of an FDA approval submission. Phase 4 studies happen after a treatment is approved, monitoring long-term safety and effectiveness in real-world use. Some trials register without a phase — common for device, behavioral, or observational studies.
Where does this trial data come from?
All trial data is pulled directly from the ClinicalTrials.gov API v2, the official federal trial registry maintained by the National Library of Medicine at NIH. Under FDAAA 801, most U.S. drug and device trials are required to register, making ClinicalTrials.gov the most comprehensive source. Sponsors are responsible for keeping their listings current; trial status can shift between data refreshes.
How This Sponsor Page Is Built
Every count on this page is derived directly from ClinicalTrials.gov API v2 records. Trial counts include all trials currently registered to this sponsor; the recruiting count reflects trials with status "Recruiting" or equivalent. Plain-English eligibility translations on each linked trial page preserve the original clinical text alongside an accessible version. Read the full methodology for the data pipeline and limitations.
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Source: ClinicalTrials.gov API v2, maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. Data: ClinicalTrials.gov."
Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.
Last updated 2026-06-26 · 4 trials tracked for BioNTech SE.