RecruitingPhase 1Phase 2NCT04197596

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

Sponsor

New York Medical College

Enrollment

40 participants

Start Date

Jul 1, 2020

Study Type

INTERVENTIONAL

Conditions

Viral Infection Primary Immune Deficiency Disorder

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).

Eligibility

Min Age: 1 MonthMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called BK CTL for people with primary immune deficiency disorder and viral infection. The study is currently recruiting participants at 7 locations. People eligible for this study include aged 1 Month to 79 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALBK 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).