BK PolyomavirusEarly Phase 1BK-CTLsNCT04293042
Treatment of BK Virus Infection With CTL Cells in Immunocompromised Transplant Patients
A Early Phase 1 study testing BK-virus specific CTLs in people with BK Polyomavirus, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This is a pilot study using cytotoxic T lymphocytes (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Gamma-capture system will be effective in decreasing specific viral load in patients with BK virus viremia and BK virus-associated symptoms post-allogeneic hematopoietic stem cell transplantation (HSCT), renal… Read more about this study
- Who is it for?
- Ages 5 weeks to 25 years
- Conditions the study is for
- BK Polyomavirus
- What is being tested?
- BK-virus specific CTLs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2019to 30 Jan 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 weeks to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient Eligibility
- Patients with symptoms of cystitis and elevated BK virus DNA by screening PCR as above (section 4) post allogeneic HSCT, post chemotherapy
- Symptoms of cystitis may include: hematuria (microscopic or gross), pain with urination, frequency, bladder spasms.
- 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)
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- 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).
- Original allogeneic donor if available, IgG positive for BKV or confirmatory testing to respond to BKV MACS Peptivator®.
- 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.
Who cannot join
- 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%
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Megan Atkinson, 215-590-2820, cttsbmtintake@chop.edu
Patricia Hankins, BSN, RN, CCRC, 215-590-5168, hankinsp@chop.edu
About this study
Official title: A Pilot Study in the Treatment of BK Virus Infection With Cytotoxic T Cells in Immunocompromised Transplant Patients
This is a pilot study using cytotoxic T lymphocytes (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Gamma-capture system will be effective in decreasing specific viral load in patients with BK virus viremia and BK virus-associated symptoms post-allogeneic hematopoietic stem cell transplantation (HSCT), renal transplantation, and chemotherapy.
Read the detailed description
This open-label, single-arm clinical trial will assess the safety and efficacy of BK virus-specific CTLs isolated from whole blood or leukapheresis products. The BK virus -specific CTLs will be generated automatically by the CliniMACS® Prodigy using the CliniMACS Cytokine Capture System (IFNgamma) after incubation with MACS GMP PepTivator® Peptide Pools of BKV VP1 and BKV LT.
- Conditions
- BK Polyomavirus
- Being tested
- BK-virus specific CTLs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BK-virus specific CTLsBiological
HLA Matched Related Donors: BK-virus specific CTLs (2.5 x 104 CD3/kg) infused intravenously on day 0 and may be additionally reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of five total infusions (maximum 12.5 x 104 CD3/kg).
HLA Mismatched Related Donors: BK-virus specific CTLs (0.5x104 CD3/kg) infused intravenously on day 0 and may additionally be reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of five total infusions (maximum 2.5 x 104 CD3/kg).
| Study group | Role | What they receive |
|---|---|---|
| BK cystitis and/or nephropathy | Experimental | All patients with symptoms that are consistent with BK cystitis and/or nephropathy (frequency, dysuria, hematuria, elevated creatinine) will have serum quantitative DNA PCR for BK virus level measured in log copies per mL (results also expressed in copies per milliliter), performed in the Children's Hospital of Philadelphia Infectious Disease Diagnostics Laboratory Receives: Biological: BK-virus specific CTLs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Grade III-IV acute GVHD
Number of participants with Grade III-IV acute GVHD as assessed by CTCAE v4.0
Measured: Up to 8 weeks after last BK-CTL infusion
Number of patients with undetectable BK viral load
Number of patients with undetectable BK viral load as measured by qPCR
Measured: 12 weeks after first BK-CTL infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start7 Oct 2019
- Primary completion30 Jan 2028 (estimated)
- Study completion30 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BK PolyomavirusStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This open-label, single-arm clinical trial
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caitlin Elgarten, Children's Hospital of Philadelphia
- Investigators
- Caitlin Elgarten, MD, MSCE, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04293042
- Sponsor's protocol ID
- 19-016545
- Acronym
- BK-CTLs
- Status last verified
- Jun 2026
- First submitted
- 23 Jan 2020
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study in the Treatment of BK Virus Infection With Cytotoxic T Cells in Immunocompromised Transplant Patients
- ClinicalTrials.gov ID
- NCT04293042
- Acronym / sponsor ID
- BK-CTLs / 19-016545
- Conditions
- BK Polyomavirus
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 30 Jan 2028 (estimated)
- Study completion
- 30 Jan 2029 (estimated)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study using cytotoxic T lymphocytes (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Gamma-capture system will be effective in decreasing specific viral load in patients with BK virus viremia and BK virus-associated symptoms post-allogeneic hematopoietic stem cell transplantation (HSCT), renal transplantation, and chemotherapy.
Detailed description
This open-label, single-arm clinical trial will assess the safety and efficacy of BK virus-specific CTLs isolated from whole blood or leukapheresis products. The BK virus -specific CTLs will be generated automatically by the CliniMACS® Prodigy using the CliniMACS Cytokine Capture System (IFNgamma) after incubation with MACS GMP PepTivator® Peptide Pools of BKV VP1 and BKV LT.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This open-label, single-arm clinical trial
| Arm | Type | Receives |
|---|---|---|
| BK cystitis and/or nephropathy | Experimental | Biological: BK-virus specific CTLsAll patients with symptoms that are consistent with BK cystitis and/or nephropathy (frequency, dysuria, hematuria, elevated creatinine) will have serum quantitative DNA PCR for BK virus level measured in log copies per mL (results also expressed in copies per milliliter), performed in the Children's Hospital of Philadelphia Infectious Disease Diagnostics Laboratory |
Who may qualify
- Ages
- 5 weeks to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- Patient Eligibility
- Patients with symptoms of cystitis and elevated BK virus DNA by screening PCR as above (section 4) post allogeneic HSCT, post chemotherapy
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BK-virus specific CTLsHLA Matched Related Donors: BK-virus specific CTLs (2.5 x 104 CD3/kg) infused intravenously on day 0 and may be additionally reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of five total infusions (maximum 12.5 x 104 CD3/kg). HLA Mismatched Related Donors: BK-virus specific CTLs (0.5x104 CD3/kg) infused intravenously on day 0 and may additionally be reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of five total infusions (maximum 2.5 x 104 CD3/kg). | Biological | BK cystitis and/or nephropathy |
Primary outcome
Number of participants with Grade III-IV acute GVHD
Time frame: Up to 8 weeks after last BK-CTL infusion
Number of participants with Grade III-IV acute GVHD as assessed by CTCAE v4.0
Number of patients with undetectable BK viral load
Time frame: 12 weeks after first BK-CTL infusion
Number of patients with undetectable BK viral load as measured by qPCR
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for BK Polyomavirus
RecruitingPhase 1
TETRAVI Multivirus CTL for Treatment of EBV, CMV, Adenovirus, and BK Infections Post Allogeneic SCT.
Viral Infection
RecruitingPhase 2
A Trial to Evaluate the Safety, Tolerability and Efficacy of AIC263029 in Kidney Transplant Recipients With BKV Infection
BK Virus Infection, BKV Infection
Not yet recruitingEarly Phase 1
25BT056: Basket Study of Viral Cytotoxic T Lymphocytes
EBV Viremia, CMV Viremia
Enrolling by invitationObservational study
ID-ENTITY Trial- Evaluating Serial T-ID Monitoring
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Active, not recruitingPhase 2
Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis
Transplantation Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caitlin Elgarten, MD, MSCE principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BK-virus specific CTLs in people with BK Polyomavirus, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Megan Atkinson (215-590-2820, cttsbmtintake@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Grade III-IV acute GVHD (time frame: Up to 8 weeks after last BK-CTL infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.