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RECRUITING
NCT04293042
EARLY_PHASE1

Treatment of BK Virus Infection With CTL Cells in Immunocompromised Transplant Patients

Sponsor: Children's Hospital of Philadelphia

View on ClinicalTrials.gov

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

BIOLOGICAL

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