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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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1 and older

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:


  • Are 1 year old or older
  • 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 BirminghamRecruiting

Birmingham, Alabama

Stanford UniversityNot yet recruiting

Palo Alto, California

City of HopeRecruiting

Duarte, California

University of California, San Francisco Medical CenterRecruiting

San Francisco, California

University of Colorado HospitalRecruiting

Aurora, Colorado

Yale University School of MedicineNot yet recruiting

New Haven, Connecticut

Children's National Medical CenterRecruiting

Washington, District of Columbia

MoffittNot yet recruiting

Tampa, Florida

University of Florida - Division of Hematology & OncologyNot yet recruiting

Gainesville, Florida

Children's Healthcare of AtlantaNot yet recruiting

Atlanta, Georgia

Northside HospitalNot yet recruiting

Atlanta, Georgia

Indiana University HospitalRecruiting

Indianapolis, Indiana

University of Kansas Cancer CenterRecruiting

Kansas City, Kansas

Johns Hopkins MedicineNot yet recruiting

Baltimore, Maryland

University of Maryland Medical CenterRecruiting

Baltimore, Maryland

Dana Farber Cancer InstituteNot yet recruiting

Boston, Massachusetts

University of MinnesotaRecruiting

Minneapolis, Minnesota

Washington University School of MedicineNot yet recruiting

Saint Louis, Missouri

Children's Mercy Hospital - Kansas CityRecruiting

Kansas City, Missouri

Hackensack University Medical CenterNot yet recruiting

Hackensack, New Jersey

Columbia UniversityNot yet recruiting

New York, New York

Mayo ClinicNot yet recruiting

Rochester, New York

Roswell Park Comprehensive Cancer CenterNot yet recruiting

Buffalo, New York

Weil Medical College - NY Presbyterian HospitalNot yet recruiting

New York, New York

Stony Brook University Hospital Cancer CenterRecruiting

Stony Brook, New York

Levine Cancer CenterNot yet recruiting

Charlotte, North Carolina

Nationwide Children's HospitalNot yet recruiting

Columbus, Ohio

Oregon Health & Science UniversityNot yet recruiting

Portland, Oregon

University of PennsylvaniaNot yet recruiting

Philadelphia, Pennsylvania

Medical University of South CarolinaNot yet recruiting

Charleston, South Carolina

Baylor University Medical CenterNot yet recruiting

Dallas, Texas

Children's Medical Center DallasNot yet recruiting

Dallas, Texas

University of VirginiaRecruiting

Charlottesville, Virginia

Fred Hutchinson Cancer Research CenterRecruiting

Seattle, Washington

Froedtert Hospital and the Medical College of WisconsinNot yet recruiting

Milwaukee, Wisconsin

ClinicalTrials.gov record


NCT05305040

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