Pilot Study of Donor-Derived BK Virus Specific Cytotoxic T-Cells to Treat Refractory BK Infections in Children, Adolescents, and Young Adults After Stem Cell or Organ Transplant or with Immune Disorders

What this Trial Is About

Researchers are studying the safety and effectiveness of BK cytotoxic T cells CTLs made using the Miltenyi CliniMACS Prodigy Cytokine Capture System. This study focuses on children, adolescents, and young adults with difficult-to-treat BK infections after Allogeneic Hematopoietic Stem Cell Transplantation AlloHSCT or those with primary immunodeficiencies. The goal is to see if these donor-derived BK CTLs can reduce the viral load in these patients. Participants with refractory BK infection will receive up to 20 infusions of BK CTLs from related donors. Patients with HLA matched related donors will get an initial infusion of BK CTLs intravenously on day 0, with possible reinfusions every two weeks depending on safety and effectiveness, up to 20 infusions. Those with HLA mismatched related donors will receive a lower dose with up to five total infusions on a similar schedule. During the study, researchers will monitor participants for treatment-emergent adverse events over 12 weeks to assess safety and tolerability. Participants will undergo various evaluations including viral load testing and clinical assessments. The study involves close monitoring for side effects and treatment response, with participation lasting through the treatment and follow-up periods as defined by the research protocol.

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