for people ages 1 month to 79 years (full criteria)
at San Francisco, California and other locations
study started
completion around



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).

Official Title

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


Viral Infection, Primary Immune Deficiency Disorder, Infections, Communicable Diseases, Virus Diseases, Primary Immunodeficiency Diseases, Immunologic Deficiency Syndromes, BK CTL


For people ages 1 month to 79 years

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


  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


  • UCSF accepting new patients
    San Francisco California 94158 United States
  • Children's Hospital of Colorado accepting new patients
    Aurora Colorado 80045 United States


accepting new patients
Start Date
Completion Date
New York Medical College
Phase 1/2 research study
Study Type
Expecting 40 study participants
Last Updated