A Pilot Study in the Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs) in Children, Adolescents and Young Adult Recipients
New York Medical College
Summary
BK cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be safe and effective in decreasing specific viral load in children, adolescents and young adults (CAYA) with refractory BK infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT) or with primary immunodeficiencies (PID).
Eligibility
- Age range
- 0–79 years
- Sex
- All
- Healthy volunteers
- No
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…