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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Patient with refractory BK infection and a HLA Matched Related Donors: BK specific CTLs (2.5 x 104 CD3/kg) infused intravenously on day 0 and may be additionally reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of five total infusions (maximum 12.5 x 104 CD3/kg). Patients with refractory BK virus and a HLA Mismatched Related Donors: BK specific CTLs (0.5x104 CD3/kg) infused intravenously on day 0 and may additionally be reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of five total infusions (maximum 2.5 x 104 CD3/kg).
University of California San Francisco
San Francisco, California, United States
RECRUITINGChildren's Hospital of Colorado
Aurora, Colorado, United States
RECRUITINGJohns Hopkins
Baltimore, Maryland, United States
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Patients will be monitored for adverse events following each CTL infusion
Time frame: 12 weeks
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Washington University
St Louis, Missouri, United States
RECRUITINGNew York Medical College
Valhalla, New York, United States
RECRUITINGNationwide Children's Hosptial
Columbus, Ohio, United States
RECRUITINGChildren's Hospital of Pennsylvania
Philadelphia, Pennsylvania, United States
RECRUITINGMedical College of Wisconsin
Milwaukee, Wisconsin, United States
RECRUITING