NCT04197596

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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: New York Medical College · Academic / Other
• Sex: All
• Age: 1 Month – 79 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Viral Infection
• Primary Immune Deficiency Disorder

Interventions

Type	Name	Description
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 twenty 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).

Timeline

• Start date: 2020-07-01
• Primary completion: 2026-12-31
• Completion: 2027-06-30
• First posted: 2019-12-13
• Last updated: 2026-04-15

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated drug study