Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)

Inclusion Criteria

• •.1.1 Patients with refractory BK infection post allogeneic HSCT, post solid organ transplantation or with primary immunodeficiencies with either
• •Increasing urine and/or plasma BK RT-PCR DNA (by 1 log) after 7 days or persistent quantitative qRT-PCR DNA copies after 14 days despite two weeks of appropriate anti-viral therapy AND/OR
• •Medical intolerance to anti-viral therapies including:
• •* 2 renal toxicity with cidofovir or other \> grade 2 toxicities secondary to cidofovir And/or
• •known resistance to cidofovir 1.2. Consent: Written informed consent given (by patient or legal representative) prior to any study-related procedures.
• •1.3 Performance Status \> 30% (Lansky \< 16 yrs and Karnofsky \> 16 yrs) 1.4 Age: 0.1 to 79.99 years 1.5 Females of childbearing potential with a negative urine pregnancy test
• •Exclusion:
• •1. Patient with acute GVHD \> grade 2 or extensive chronic GVHD at the time of BK CTL infusion
• •2. Patient receiving steroids (\>0.5 mg/kg prednisone equivalent) at the time of BK CTL infusion
• •3. Patient treated with donor lymphocyte infusion (DLI) within 4 weeks prior to BK CTL infusion
• •4. Thymoglobulin (ATG) or Alemtuzumab within 30 days
• •5. Patient with poor performance status determined by Karnofsky (patients \>16 years) or Lansky (patients ≤16 years) score ≤30%
• •6. Concomitant enrollment in another experimental clinical trial investigating the treatment of refractory BK infection.
• •7. Any medical condition which could compromise participation in the study according to the investigator's assessment
• •8. Known HIV infection
• •9. Female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment.
• •10. Known hypersensitivity to iron dextran
• •11. Patients unwilling or unable to comply with the protocol or unable to give informed consent.
• •12. Known human anti-mouse antibodies