Actively Recruiting
Treatment of BK Virus Infection With CTL Cells in Immunocompromised Transplant Patients
Led by Children's Hospital of Philadelphia · Updated on 2025-04-29
20
Participants Needed
1
Research Sites
481 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treatment of BK Virus Infection With CTL Cells in Immunocompromised Transplant Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with symptoms of cystitis and elevated BK virus DNA by screening PCR after allogeneic HSCT or chemotherapy
- Symptoms may include microscopic or gross hematuria, pain with urination, frequency, and bladder spasms
- Patients may receive standard cystitis treatments such as hydration, antiviral medications, or surgery
- Written informed consent provided by patient or legal representative before any study procedures
- Performance status greater than 30% (Lansky score for patients under 16 years, Karnofsky score for patients 16 years and older)
- Age between 0.1 weeks and 25 years
- Females of childbearing potential must have a negative urine pregnancy test
- Related donor available with T-cell response to BK virus MACS PepTivator antigen(s)
- Original allogeneic donor positive for BK virus IgG or confirmed T-cell response to BK virus peptide
- If original donor unavailable or non-responsive, a third-party related donor with at least one HLA A, B, DR match and T-cell response to BK virus peptide
- Donor disease screening completed according to hematopoietic stem cell donor standards
- Donor or donor representative provided informed consent before collection
You will not qualify if you...
- Acute GVHD grade greater than 2 or extensive chronic GVHD at time of BK Virus CTL infusion
- Receiving steroids over 0.5 mg/kg prednisone equivalent at infusion or within 3 days before infusion
- Received thymoglobulin (ATG), campath, or T cell immunosuppressive monoclonal antibodies within 30 days
- Poor performance status: Karnofsky or Lansky score 30% or less
- Enrolled in another experimental clinical trial for refractory BK virus infection
- Any medical condition that could compromise study participation as judged by the investigator
- Known HIV infection
- Female patients pregnant, breastfeeding, or unwilling to use effective birth control during study
- Known hypersensitivity to iron dextran
- Unable or unwilling to comply with study protocol or provide informed consent
- Presence of known human anti-mouse antibodies
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
M
Megan Atkinson
CONTACT
P
Patricia Hankins, BSN, RN, CCRC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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