A monoclonal antibody approach to treat BK virus infection.
Official title: New Therapeutic Approach Against BK Virus Infection Based on Monoclonal Antibodies
Run by University Hospital, Strasbourg, France · NCT05264259 · Data updated 2026-11-12
This observational project will collect data to see if monoclonal antibody–based approaches could help adults with BK virus infection after transplantation.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg) |
| Status | Recruiting |
| Started | September 5, 2022 |
| Main results expected | September 5, 2022 |
| Study ends | December 1, 2025 |
| Registry record updated | August 8, 2025 |
| Trial ID | NCT05264259 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults who are BK virus–positive and able to give informed consent, typically transplant recipients, are the intended participants.
✕Probably not a fit
People who are minors, under guardianship or curatorship, legally deprived of liberty, or who decline participation are excluded and would not directly benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers at the University Hospital Strasbourg will enroll BK virus–positive adults and follow their clinical course and laboratory markers over time. The protocol is observational and will collect virological data, clinical outcomes, and immune-related measurements to identify antibody targets and biomarkers. Collected data and samples may be used to support the development of monoclonal antibody treatments and to select candidates for future interventional trials. No experimental therapy is administered as part of this protocol.
Why it matters
Potential benefit: If successful, this work could identify monoclonal antibody strategies that reduce BK virus complications and improve transplant outcomes.
How similar studies have gone: While monoclonal antibodies have been effective for other viral infections, their use specifically against BK virus is largely novel with limited clinical evidence so far.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * BK positive * adult * ok to participed to research Exclusion Criteria: * under guardianship * under curatorship * opposed to research * deprived of liberty
Where it's running
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Service de Virologie - CHU Strasbourg - France
Strasbourg, France Recruiting
Study contacts
- Principal investigator: Samira FAFI-KREMER — University Hospital, Strasbourg, France
- Study coordinator: Anne-Sophie U GEY
- Email: anne-sophie.gey@chru-strasbourg.fr
- Phone: +33 388116684
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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AIC263029 in kidney transplant recipients with BK virus infection
This trial tests whether AIC263029 is safe and tolerable and can lower BK virus levels in adults who recently had a kidney transplant and have BK viremia, compared with placebo.
-
BK virus in kidney transplant patients and donors: who carries the virus and why
This study tests BK virus in kidney transplant recipients and their donors to see where the virus comes from and how the immune system responds.
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R-MVST cell therapy for viral infections in children and young adults
This will try giving rapidly generated virus-specific T cells (R-MVST) to children and young adults whose weakened immune systems have recurrent or treatment-resistant infections with EBV, CMV, adenovirus, or BK virus.
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Registry for understanding BK virus in kidney transplant patients
This study is trying to understand how the immune system responds to BK virus infections in kidney transplant patients to see how different treatments can help manage the virus and prevent complications.
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Treatment of viral infections using rapidly generated T cells
This study is testing a new treatment using specially made T cells to help patients with weakened immune systems who are struggling with serious viral infections like Epstein-Barr or cytomegalovirus.
-
Using donor T cells to treat cancer patients with BK and JC viruses
This study is testing if infusions of special immune cells from donors can help cancer patients with BK or JC virus infections feel better and fight their illness.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.