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Viral specific T cells (VSTs), posoleucel (ALVR105), to prevent viral infections after an allogeneic (cells from a donor) blood or marrow transplant (BMT) in children and adults

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Phase 2, Phase 3

35 Locations

NCT05305040

Clinical Trial Goal


To find out if posoleucel is safe and works well to prevent viral infections after allogeneic BMT in children and adults

You may be able to join this trial if you:


  • Have an infection with one of the following:
    • Adenovirus (AdV)
    • BK virus (BKV)
    • Cytomegalovirus (CMV)
    • Epstein-Barr virus (EBV)
    • Human herpes virus-6 (HHV-6)
    • JC virus (JCV)
  • Had an allogeneic BMT in the last 6 weeks
  • Have a posoleucel product that is a match to you. Your doctor and the clinical trial doctors can tell you this
  • Do not have graft-versus-host disease (GVHD) that doctors consider grade 2 or higher
  • Are not being treated with high-dose steroids. Your doctor can tell you this
  • Agree to have other standard tests done to see if you can be in the clinical trial 

Trial Details


Posoleucel is made from VSTs. VSTs are a type of immune cell that know how to find and destroy viruses. In this trial, VSTs are previously collected from donors.

Everyone in the trial will get standard treatment if they develop an infection.

In this trial, you’ll be randomized to 1 of 2 groups. Once you’re randomized, you and the clinical trial doctors won’t know which group you’re in until after the trial is finished:
Group 1 – Posoleucel
Group 2 Placebo  

Randomized means doctors will use a computer to assign you to either group. A computer assigns you by chance, like flipping a coin or drawing a name out of a hat. You, your doctor or the clinical trial doctor won’t have any control over which group you’ll be assigned. This means you won’t be able to choose your group.  

You'll get:
  • Posoleucel – (Group 1 only) – Given as an intravenous (IV) infusion 7 times in 3 months
  • Placebo – (Group 2 only) – Given as an IV infusion with no medicine in it 7 times in 3 months

The clinical trial doctors will check your health for about 6 months.   

The Food and Drug Administration (FDA) not yet approved posoleucel. 

Contacts


Dee Rodriguez, 833-409-2281, ClinicalTrials@allovir.com

Locations

University of Alabama at Birmingham Children's of AlabamaRecruiting

Birmingham, Alabama

Honor Health Research InstituteRecruiting

Scottsdale, Arizona

City of HopeRecruiting

Duarte, California

Stanford UniversityRecruiting

Palo Alto, California

University of California, Los Angeles (UCLA)Recruiting

Los Angeles, California

University of California San Francisco - Benioff Children's HospitalRecruiting

San Francisco, California

University of Colorado HospitalRecruiting

Aurora, Colorado

Yale University School of Medicine - Yale Cancer CenterRecruiting

New Haven, Connecticut

Childrens National Health SystemRecruiting

Washington, District of Columbia

Moffitt Cancer CenterRecruiting

Tampa, Florida

University of Florida (UF) - GainesvilleRecruiting

Gainesville, Florida

Northside HospitalRecruiting

Atlanta, Georgia

Loyola University Medical CenterRecruiting

Maywood, Illinois

Indiana University Hospital Simon Comprehensive Cancer CenterRecruiting

Indianapolis, Indiana

University of Kansas HospitalRecruiting

Kansas City, Kansas

University of MarylandRecruiting

Baltimore, Maryland

Dana-Farber Cancer InstituteRecruiting

Boston, Massachusetts

University of MinnesotaRecruiting

Minneapolis, Minnesota

Children's Mercy HospitalRecruiting

Kansas City, Missouri

Washington University School of MedicineRecruiting

Saint Louis, Missouri

Hackensack University Medical CenterRecruiting

Hackensack, New Jersey

Columbia UniversityRecruiting

New York, New York

Roswell Park Cancer InstituteRecruiting

Buffalo, New York

Stony Brook University Hospital Cancer CenterRecruiting

Stony Brook, New York

Weill Cornell Medical CollegeRecruiting

New York, New York

Carolinas Medical Center/LevineRecruiting

Charlotte, North Carolina

Nationwide Children's HospitalRecruiting

Columbus, Ohio

Oregon Health & Science UniversityRecruiting

Portland, Oregon

University of PennsylvaniaRecruiting

Philadelphia, Pennsylvania

Children's Medical Center DallasRecruiting

Dallas, Texas

University of Utah/Primary Childrens HospitalRecruiting

Salt Lake City, Utah

University of VirginiaRecruiting

Charlottesville, Virginia

Virginia Commonwealth UniversityRecruiting

Richmond, Virginia

Fred Hutchinson Cancer Research CenterRecruiting

Seattle, Washington

Froedtert Hospital and the Medical College of WisconsinRecruiting

Milwaukee, Wisconsin

ClinicalTrials.gov record


NCT05305040. First posted on 3/31/22

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