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

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 study tests BK-specific cytotoxic T lymphocytes (CTLs) — immune cells from a related donor that are trained to fight BK virus — to treat severe BK virus infections that haven't responded to standard antiviral therapy. BK virus is common and harmless in healthy people, but in immunocompromised patients (such as those who have received a stem cell transplant or organ transplant), it can cause serious bladder and kidney damage. Standard antivirals often don't work well in these patients, making this cell therapy a critical experimental option. Participants are patients with persistent or worsening BK infection after a transplant who have failed or are intolerant to conventional antiviral treatments. Donor-derived T cells are infused to help the immune system control the virus. You may be eligible if... - You have a BK virus infection after an allogeneic stem cell transplant, solid organ transplant, or due to a primary immunodeficiency - BK viral loads are rising or persistent despite at least 2 weeks of appropriate antiviral therapy, or you cannot tolerate antiviral medications - You are between approximately 1 month and 79 years old - Your performance status is above the minimum threshold (Lansky/Karnofsky >30%) You may NOT be eligible if... - You have acute graft-versus-host disease (GVHD) grade 2 or higher - You are on high-dose steroids (>0.5 mg/kg prednisone) at the time of infusion - You have had a donor lymphocyte infusion in the last 4 weeks - You are pregnant or breastfeeding - You have known HIV infection Talk to your doctor to see if this trial is right for you.

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).


Locations(7)

University of California San Francisco

San Francisco, California, United States

Johns Hopkins

Baltimore, Maryland, United States

Washington University

St Louis, Missouri, United States

New York Medical College

Vallhala, 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

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NCT04197596


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