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RECRUITING
NCT04197596
PHASE1/PHASE2

Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)

Sponsor: New York Medical College

View on ClinicalTrials.gov

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

Key Details

Gender

All

Age Range

1 Month - 79 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2020-07-01

Completion Date

2025-06-30

Last Updated

2024-05-31

Healthy Volunteers

No

Interventions

BIOLOGICAL

BK CTL

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).

Locations (8)

University of California San Francisco

San Francisco, California, United States

Children's Hospital of Colorado

Aurora, Colorado, United States

Johns Hopkins

Baltimore, Maryland, United States

Washington University

St Louis, Missouri, United States

New York Medical College

Valhalla, New York, United States

Nationwide Children's Hosptial

Columbus, Ohio, United States

Children's Hospital of Pennsylvania

Philadelphia, Pennsylvania, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States