Immune cells take on BK virus in vulnerable transplant patients
NCT ID NCT04293042
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether specially grown immune cells (called cytotoxic T lymphocytes) can safely lower BK virus levels in 20 transplant patients with weakened immune systems. Participants have had a stem cell or kidney transplant and show signs of BK virus infection. The goal is to see if the treatment reduces virus levels and controls symptoms without causing severe side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2019
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 weeks to 25 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Patient Eligibility * Patients with symptoms of cystitis and elevated BK virus DNA by screening PCR as above (section 4) post allogeneic HSCT, post chemotherapy 1. Symptoms of cystitis may include: hematuria (microscopic or gross), pain with urination, frequency, bladder spasms. 2. Patient may be otherwise treated for cystitis as per local institutional standards. Such treatments may include hydration, antiviral medications, or surgical intervention as deemed appropriate by treating physician. * Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures. * Performance Status \> 30% (Lansky \< 16 yrs and Karnofsky \> 16 yrs) * Age: 0.1 to 25 years * Females of childbearing potential with a negative urine pregnancy test. Donor Eligibility * Related donor available with a T-cell response to the BK-virus MACS® PepTivator® antigen(s). 1. Original allogeneic donor if available, IgG positive for BKV or confirmatory testing to respond to BKV MACS Peptivator®. 2. Third Party Allogeneic Donor: If original donor is not available or does not have a T-cell response: third party allogeneic donor (family donor \> 1 HLA A, B, DR match to recipient) with a T-cell response to the BK MACS® PepTivator. AND * Allogeneic donor disease screening is complete similar to hematopoietic stem cell donors (Appendix 1). AND • Obtained informed consents by donor or donor legally authorized representative prior to donor collection. Exclusion Criteria: Patient exclusion criteria: A patient meeting any of the following criteria is not eligible for the present study: * Patient with acute GVHD \> grade 2 or extensive chronic GVHD at the time of BK Virus CTL infusion * Patient receiving steroids (\>0.5 mg/kg prednisone equivalent) at the time of BK Virus CTL infusion or within 3 days of planned infusion. * Thymoglobulin (ATG), campath or T cell immunosuppressive monoclonal antibodies within 30 days * Patient with poor performance status determined by Karnofsky (patients \>16 years) or Lansky (patients ≤16 years) score ≤30% * Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory BK virus infection. * Any medical condition which could compromise participation in the study according to the investigator's assessment * Known HIV infection * Female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment. * Known hypersensitivity to iron dextran * Patients unwilling or unable to comply with the protocol or unable to give informed consent. * Known human anti-mouse antibodies
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's Hospital of Philadelphia
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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