A Pilot Study in the Treatment of BK Virus Infection With Cytotoxic T Cells in Immunocompromised Transplant Patients
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.
∙ Patient Eligibility
• 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.
• Performance Status \> 30% (Lansky \< 16 yrs and Karnofsky \> 16 yrs)
• Age: 0.1 to 25 years
• Females of childbearing potential with a negative urine pregnancy test.
∙ Donor Eligibility
• Related donor available with a T-cell response to the BK-virus MACS® PepTivator® antigen(s).
‣ Original allogeneic donor if available, IgG positive for BKV or confirmatory testing to respond to BKV MACS Peptivator®.
⁃ Third Party Allogeneic Donor: If original donor is not available or does not have a T-cell response: third party allogeneic donor (family donor \> 1 HLA A, B, DR match to recipient) with a T-cell response to the BK MACS® PepTivator.
‣ AND
• Allogeneic donor disease screening is complete similar to hematopoietic stem cell donors (Appendix 1).
∙ AND
∙ • Obtained informed consents by donor or donor legally authorized representative prior to donor collection.