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Treatment of BK Virus Infection With CTL Cells in Immunocompromised Transplant Patients
Sponsor: Children's Hospital of Philadelphia
Summary
This is a pilot study using cytotoxic T lymphocytes (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Gamma-capture system will be effective in decreasing specific viral load in patients with BK virus viremia and BK virus-associated symptoms post-allogeneic hematopoietic stem cell transplantation (HSCT), renal transplantation, and chemotherapy.
Official title: A Pilot Study in the Treatment of BK Virus Infection With Cytotoxic T Cells in Immunocompromised Transplant Patients
Key Details
Gender
All
Age Range
5 Weeks - 25 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2019-10-07
Completion Date
2028-12-30
Last Updated
2025-04-29
Healthy Volunteers
No
Conditions
Interventions
BK-virus specific CTLs
HLA Matched Related Donors: BK-virus 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). HLA Mismatched Related Donors: BK-virus 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).
Locations (1)
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States