Viral InfectionPhase 1/2NCT04197596
Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)
A Phase 1/2 study testing BK CTL in people with Viral Infection and Primary Immune Deficiency Disorder, run by New York Medical College at 7 sites in United States.
Trial summary
BK cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be safe and effective in decreasing specific viral load in children, adolescents and young adults (CAYA) with refractory BK infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT) or with… Read more about this study
- Who is it for?
- Ages 1 month to 79 years
- Conditions the study is for
- Viral Infection, Primary Immune Deficiency Disorder
- What is being tested?
- BK CTL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Jul 2020to 30 Jun 2027
- Phase
- Phase 1/2
- 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 1 month to 79 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- .1.1 Patients with refractory BK infection post allogeneic HSCT, post solid organ transplantation or with primary immunodeficiencies with either
- Increasing urine and/or plasma BK RT-PCR DNA (by 1 log) after 7 days or persistent quantitative qRT-PCR DNA copies after 14 days despite two weeks of appropriate anti-viral therapy AND/OR
- Medical intolerance to anti-viral therapies including:
- 2 renal toxicity with cidofovir or other > grade 2 toxicities secondary to cidofovir And/or
- known resistance to cidofovir 1.2. Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.
- 1.3 Performance Status > 30% (Lansky < 16 yrs and Karnofsky > 16 yrs) 1.4 Age: 0.1 to 79.99 years 1.5 Females of childbearing potential with a negative urine pregnancy test
Who cannot join
- Patient with acute GVHD > grade 2 or extensive chronic GVHD at the time of BK CTL infusion
- Patient receiving steroids (>0.5 mg/kg prednisone equivalent) at the time of BK CTL infusion
- Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to BK CTL infusion
- Thymoglobulin (ATG) or Alemtuzumab 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 infection.
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- 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
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Johns Hopkins
Baltimore, Maryland, 21287
Kenneth Cooke, MD
- Recruiting
Nationwide Children's Hosptial
Columbus, Ohio, 43205
Dean Lee, MD, PhD, (614) 722-3550, Dean.Lee@nationwidechildrens.org
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Julie A Talano, MD, 414-955-4185, jtalano@mcw.edu
Meredith Beversdorf, RN, (414) 266-5891, mbeversdorf@mcw.edu
- Recruiting
Children's Hospital of Pennsylvania
Philadelphia, Pennsylvania, 19104
Nancy Bunin, MD, 215 590-2255, buninn@email.chop.edu
- Recruiting
University of California San Francisco
San Francisco, California, 94158
Julia Chu, MD, Julia.Chu2@ucsf.edu
- Recruiting
Washington University
St Louis, Missouri, 63130
Shalini Shenoy, MD, shalinishenoy@wustl.edu
- Recruiting
New York Medical College
Vallhala, New York, 10595
Mitchell S Cairo, MD, 914-594-2150, mitchell_cairo@nymc.edu
Lauren Harrison, RN, 6172857844, lauren_harrison@nymc.edu
About this study
Official title: A Pilot Study in the Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs) in Children, Adolescents and Young Adult Recipients
BK cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be safe and effective in decreasing specific viral load in children, adolescents and young adults (CAYA) with refractory BK infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT) or with primary immunodeficiencies (PID).
- Being tested
- BK CTL
- Medical subject headings
- Virus Diseases, Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BK CTLBiological
Patient with refractory BK infection and a HLA Matched Related Donors: BK 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 twenty total infusions (maximum 12.5 x 104 CD3/kg).
Patients with refractory BK virus and a HLA Mismatched Related Donors: BK 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 CTL | Experimental | Eligible patients with refractory BK infection will receive up to 20 infusions of BK CTLs that are donor derived. Receives: Biological: BK CTL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Patients will be monitored for adverse events following each CTL infusion
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2019
- Study start1 Jul 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral InfectionStudies of the same condition, open and under way.
- 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Medical College of Wisconsin, Nationwide Children's Hospital, Johns Hopkins University, University of California, San Francisco
- Responsible party
- Sponsor
- Investigators
- Mitchell S Cairo, MD, Principal investigator, New York Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197596
- Sponsor's protocol ID
- NYMC 590
- Status last verified
- Apr 2026
- First submitted
- 11 Dec 2019
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study in the Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs) in Children, Adolescents and Young Adult Recipients
- ClinicalTrials.gov ID
- NCT04197596
- Acronym / sponsor ID
- NYMC 590
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- New York Medical CollegeUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Medical College of Wisconsin, Nationwide Children's Hospital, Johns Hopkins University, University of California, San Francisco
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Dec 2019 (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.
BK cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be safe and effective in decreasing specific viral load in children, adolescents and young adults (CAYA) with refractory BK infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT) or with primary immunodeficiencies (PID).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BK CTL | Experimental | Biological: BK CTLEligible patients with refractory BK infection will receive up to 20 infusions of BK CTLs that are donor derived. |
Who may qualify
- Ages
- 1 month to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- .1.1 Patients with refractory BK infection post allogeneic HSCT, post solid organ transplantation or with primary immunodeficiencies with either
- Increasing urine and/or plasma BK RT-PCR DNA (by 1 log) after 7 days or persistent quantitative qRT-PCR DNA copies after 14 days despite two weeks of appropriate anti-viral therapy AND/OR
- Medical intolerance to anti-viral therapies including:
- known resistance to cidofovir 1.2. Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.
- 1.3 Performance Status > 30% (Lansky < 16 yrs and Karnofsky > 16 yrs) 1.4 Age: 0.1 to 79.99 years 1.5 Females of childbearing potential with a negative urine pregnancy test
Key exclusion criteria (12 listed)
- Patient with acute GVHD > grade 2 or extensive chronic GVHD at the time of BK CTL infusion
- Patient receiving steroids (>0.5 mg/kg prednisone equivalent) at the time of BK CTL infusion
- Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to BK CTL infusion
- Thymoglobulin (ATG) or Alemtuzumab within 30 days
- Patient with poor performance status determined by Karnofsky (patients >16 years) or Lansky (patients ≤16 years) score ≤30%
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 CTLPatient with refractory BK infection and a HLA Matched Related Donors: BK 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 twenty total infusions (maximum 12.5 x 104 CD3/kg). Patients with refractory BK virus and a HLA Mismatched Related Donors: BK 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 CTL |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 12 weeks
Patients will be monitored for adverse events following each CTL infusion
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 15 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
Mitchell S Cairo, MD principal investigator
New York Medical College
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BK CTL in people with Viral Infection and Primary Immune Deficiency Disorder, run by New York Medical College at 7 sites 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 6 inclusion and 12 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Mitchell S Cairo, MD (9145942150, mitchell_cairo@nymc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 12 weeks). 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 15 Apr 2026.