Viral specific T cells (VSTs), posoleucel, to treat virus-associated hemorrhagic cystitis (HC) after an allogeneic (cells from a donor) blood or marrow transplant (BMT) in children and adults


Phase 3

25 Locations


Clinical Trial Goal

To find out if posoleucel is safe and works well to treat virus-associated HC after allogeneic BMT in children and adults

You may be able to join this trial if you:

  • Are 1 years old or older
  • Have virus-associated HC
  • Had an allogeneic BMT in the last year
  • 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. Doctors think posoleucel can treat HC when it’s associated with adenovirus (AdV), BK virus (BKV), cytomegalovirus (CMV), Epstein Barr virus (EBV), human herpesvirus 6 (HHV-6) or JC virus (JCV). 

Everyone in this trial will get standard treatment if they get 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
  • Placebo – (Group 2 only) – Given as an IV infusion with no medicine in it  

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

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


Kyle Herbert, +1 833-409-2281,


Children's Hospital of Los AngelesRecruiting

Los Angeles, California

City of Hope National Medical CenterRecruiting

Duarte, California

Yale University School of Medicine - Yale Cancer CenterRecruiting

New Haven, Connecticut

Children's National Medical CenterRecruiting

Washington, District of Columbia


Tampa, Florida

University of MiamiRecruiting

Miami, Florida

Northside HospitalRecruiting

Atlanta, Georgia

Northwestern Memorial HospitalRecruiting

Chicago, Illinois

University of Kansas Cancer CenterRecruiting

Kansas City, Kansas

Johns Hopkins MedicineRecruiting

Baltimore, Maryland

Dana-Farber Cancer InstituteRecruiting

Boston, Massachusetts

Massachusetts General HospitalRecruiting

Boston, Massachusetts

University of MinnesotaRecruiting

Minneapolis, Minnesota

Children's Mercy Hospital - Kansas CityRecruiting

Kansas City, Missouri

University of Nebraska Medical CenterRecruiting

Omaha, Nebraska

Hackensack University Medical CenterRecruiting

Hackensack, New Jersey

Roswell Park Comprehensive Cancer CenterRecruiting

Buffalo, New York

Ohio State University Medical Center (OSUMC)Recruiting

Columbus, Ohio

University Hospitals Cleveland Medical CenterRecruiting

Cleveland, Ohio

Oregon Health & Science UniversityRecruiting

Portland, Oregon

Children's Hospital of Philadelphia (CHOP)Recruiting

Philadelphia, Pennsylvania

The University of Texas Southwestern Medical CenterRecruiting

Dallas, Texas

Virginia Commonwealth UniversityRecruiting

Richmond, Virginia

Fred Hutchinson Cancer Research CenterRecruiting

Seattle, Washington

Froedtert Hospital and the Medical College of WisconsinRecruiting

Milwaukee, Wisconsin record

NCT04390113. First posted on 5/15/20

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