Clinical Trial

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

Recruiting Phase 1/2
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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).
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2019-12-11; most recent amendment 2026-04-10.
Status change: Not Yet Recruiting → Recruiting 2020-09-24
Trial Details
NCT Number NCT04197596
Lead Sponsor New York Medical College
Collaborators: Children's Hospital of Philadelphia, Medical College of Wisconsin, Nationwide Children's Hospital, Johns Hopkins University, University of California, San Francisco
Conditions Viral Infection, Primary Immune Deficiency Disorder
Enrollment 40 participants
Start Date 2020-07-01
Primary Completion 2026-12-31 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-15