Treatment of BK Virus Infection With CTL Cells in Immunocompromised Transplant Patients

Inclusion Criteria

• •Patient Eligibility
• •Patients with symptoms of cystitis and elevated BK virus DNA by screening PCR as above (section 4) post allogeneic HSCT, post chemotherapy
• •1. Symptoms of cystitis may include: hematuria (microscopic or gross), pain with urination, frequency, bladder spasms.
• •2. 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).
• •1. Original allogeneic donor if available, IgG positive for BKV or confirmatory testing to respond to BKV MACS Peptivator®.
• •2. 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.