RecruitingPhase 2NCT03266627

Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection

A Pilot Study in the Treatment of Refractory Adenovirus (ADV) Infection With Related Donor ADV Cytotoxic T-Lymphocytes (ADV-CTLs)in Children, Adolescents and Young Adult Recipients


Sponsor

New York Medical College

Enrollment

20 participants

Start Date

Nov 1, 2018

Study Type

INTERVENTIONAL

Conditions

Summary

Related donor Adenovirus (ADV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered intravenously in in children, adolescents and young adults with refractory ADV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant. Funding Source: FDA OOPD


Eligibility

Min Age: 1 MonthMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study tests a treatment using specially engineered immune cells (cytotoxic T-lymphocytes) to fight adenovirus infections that have not responded to standard antiviral medications. It targets patients who received a stem cell or organ transplant and are now fighting a resistant adenovirus infection. You may be eligible if: - You have an adenovirus infection after a stem cell transplant, organ transplant, or due to a primary immune deficiency - The virus is not responding to at least two weeks of antiviral treatment, or you cannot tolerate the antiviral medications - You are between 1 month and 79 years old - A suitable immune cell donor is available - Female patients of childbearing age must have a negative pregnancy test You may NOT be eligible if: - You have severe graft-versus-host disease (grade 2 or higher) - You are currently taking high-dose steroids (more than 0.5 mg/kg prednisone) - You have received a donor lymphocyte infusion within the past 4 weeks - You have a very low performance status (Karnofsky/Lansky score 30% or below) - You are pregnant, breastfeeding, or not using effective contraception - You are known to be HIV positive - You have known human anti-mouse antibodies 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

DRUGcytotoxic t-lymphocytes

adenovirus specific cytotoxic t-lymphocytes will be collected and manufactured from HLA matched related or HLA mis-matched related donors and administered to eligible patients with refractory adenovirus or PID.


Locations(10)

Children's Hospital Los Angeles

Los Angeles, California, United States

University of California San Francisco

San Francisco, California, United States

Children's Hospital of Colorado

Aurora, Colorado, United States

University of Colorado Denver

Aurora, Colorado, United States

Indiana University

Indianapolis, Indiana, United States

Johns Hopkins

Baltimore, Maryland, United States

Washington University

St Louis, Missouri, United States

Nationwide Children's Hosptial

Columbus, Ohio, United States

Children's Hospital of Pennsylvania

Philadelphia, Pennsylvania, United States

Medical College of Wisconsin/Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

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NCT03266627


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