About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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%
Trial design
Treatments tested in this trial
- BK-virus specific CTLs