Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age1-79
SponsorNew York Medical College
About this trial
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 criteria
Qualifiers
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
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.
Patient with acute GVHD > grade 2 or extensive chronic GVHD at the time of BK CTL infusion
Disqualifiers
None
Trial design
Treatments tested in this trial
- BK CTL
Treatment groups
40 Participants
are divided into 1 treatment groupSponsors and collaborators
New York Medical College
Lead sponsor
Children's Hospital of Philadelphia
Collaborator
Medical College of Wisconsin
Collaborator
Nationwide Children's Hospital
Collaborator
Johns Hopkins University
Collaborator
University of California, San Francisco
Collaborator
Source ClinicalTrials.gov