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
• +9 more criteria