Actively Recruiting
Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)
Led by New York Medical College · Updated on 2026-04-15
40
Participants Needed
7
Research Sites
365 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
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).
CONDITIONS
Official 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 or solid organ transplantation or with primary immunodeficiencies
- Increasing urine or plasma BK virus levels after 7 days or persistent levels after 14 days despite two weeks of antiviral therapy
- Medical intolerance or resistance to antiviral therapies including cidofovir
- Written informed consent given 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 months and 79.99 years
- Females of childbearing potential with a negative urine pregnancy test
You will not qualify if you...
- Acute graft-versus-host disease above grade 2 or extensive chronic graft-versus-host disease at BK CTL infusion
- Receiving steroids above 0.5 mg/kg prednisone equivalent at BK CTL infusion
- Donor lymphocyte infusion within 4 weeks before BK CTL infusion
- Thymoglobulin or Alemtuzumab within 30 days
- Poor performance status (Karnofsky or Lansky score 30% or less)
- Enrolled in another experimental trial for refractory BK infection
- Any medical condition compromising study participation as assessed by investigator
- Known HIV infection
- Pregnant or breastfeeding females or unwilling to use effective birth control during treatment
- Known hypersensitivity to iron dextran
- Unable or unwilling to comply with protocol or give informed consent
- Known human anti-mouse antibodies
AI-Screening
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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
CONTACT
L
Lauren Harrison
CONTACT
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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