Actively Recruiting
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
Led by New York Medical College · Updated on 2026-04-15
40
Participants Needed
7
Research Sites
25 weeks
Total Duration
On this page
Sponsors
N
New York Medical College
Lead Sponsor
C
Children's Hospital of Philadelphia
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of BK cytotoxic T cells (CTLs) made using the Miltenyi CliniMACS Prodigy Cytokine Capture System. This study focuses on children, adolescents, and young adults with difficult-to-treat BK infections after Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT) or those with primary immunodeficiencies. The goal is to see if these donor-derived BK CTLs can reduce the viral load in these patients. Participants with refractory BK infection will receive up to 20 infusions of BK CTLs from related donors. Patients with HLA matched related donors will get an initial infusion of BK CTLs intravenously on day 0, with possible reinfusions every two weeks depending on safety and effectiveness, up to 20 infusions. Those with HLA mismatched related donors will receive a lower dose with up to five total infusions on a similar schedule. During the study, researchers will monitor participants for treatment-emergent adverse events over 12 weeks to assess safety and tolerability. Participants will undergo various evaluations including viral load testing and clinical assessments. The study involves close monitoring for side effects and treatment response, with participation lasting through the treatment and follow-up periods as defined by the research protocol.
CONDITIONS
Brief Title
Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with refractory BK infection post allogeneic HSCT, post solid organ transplantation, or with primary immunodeficiencies showing increasing or persistent BK virus despite antiviral therapy
- Medical intolerance or known resistance to antiviral therapies including cidofovir
- Written informed consent provided by patient or legal representative
- Performance status above 30% (Lansky score for under 16 years, Karnofsky score for 16 years and older)
- Age between 0.1 years (about 1 month) and 79.99 years
- Females of childbearing potential must have a negative urine pregnancy test
You will not qualify if you...
- Acute graft-versus-host disease greater than grade 2 or extensive chronic GVHD at time of BK CTL infusion
- Use of steroids above 0.5 mg/kg prednisone equivalent at time of infusion
- Donor lymphocyte infusion within 4 weeks before BK CTL infusion
- Treatment with thymoglobulin (ATG) or alemtuzumab within 30 days
- Poor performance status (Karnofsky or Lansky score 30% or less)
- Enrollment in another experimental trial for refractory BK infection
- Any medical condition that may compromise study participation
- Known HIV infection
- Pregnancy, breastfeeding, or unwillingness to use birth control for females of childbearing age
- Known hypersensitivity to iron dextran
- Inability or unwillingness to comply with protocol or give informed consent
- Presence of human anti-mouse antibodies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 40 weeks depending on number of infusions
Participants receive up to 20 infusions of BK specific cytotoxic T-cells (CTLs) from related donors. Infusions start on day 0 and may be repeated every two weeks depending on safety and efficacy.
Infusions every 2 weeks for up to 20 infusions
Duration - Up to 12 weeks
Participants are monitored for safety and treatment-emergent adverse events after completing infusions.
Visits for safety monitoring during 12 weeks after last infusion
Trial Site Locations
Total: 7 locations
1
University of California San Francisco
San Francisco, California, United States, 94158
Actively Recruiting
2
Johns Hopkins
Baltimore, Maryland, United States, 21287
Actively Recruiting
3
Washington University
St Louis, Missouri, United States, 63130
Actively Recruiting
4
New York Medical College
Vallhala, New York, United States, 10595
Actively Recruiting
5
Nationwide Children's Hosptial
Columbus, Ohio, United States, 43205
Actively Recruiting
6
Children's Hospital of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
7
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
Research Team
M
Mitchell S Cairo, MD
L
Lauren Harrison
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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