Summary

Eligibility
for people ages 1 month to 30 years (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Julia Chu, MD

Description

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).

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

Keywords

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

Eligibility

For people ages 1 month to 30 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 30.99 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

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94158 United States
  • Medical College of Wisconsin not yet accepting patients
    Milwaukee Wisconsin 53226 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
New York Medical College
ID
NCT04197596
Phase
Phase 1/2
Study Type
Interventional
Last Updated