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A drug, itolizumab, in combination with steroids, to treat acute graft-versus-host disease (GVHD)


12 and older

Phase 3

34 Locations


Clinical Trial Goal

To find out if itolizumab, in combination with steroids, is safe and works well to treat acute GVHD

You may be able to join this trial if you:

  • Are 12 years old or older 
  • Have acute GVHD
  • Have not taken other types of medication to treat the GVHD other than steroids. Your doctor can tell you this
  • Do not have cancer that has come back (relapsed)
  • You agree to have other standard tests done to see if you can be in the clinical trial

Trial Details

Itolizumab is a monoclonal antibody that targets CD6 on certain cells.

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 – Itolizumab plus steroids
  • Group 2Placebo plus steroids

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:
  • Itolizumab (Group 1 only) – Given an IV infusions 1 time every 2 weeks for 14 weeks. The dose you’ll get will be the highest dose shown to be safe in Phase 1
  • Placebo (Group 2 only) – Given as IV infusions with a liquid with no medicine in it 1 time every 2 weeks for 14 weeks
  • Steroids 

The clinical trial doctors will check your health for about 1 year.

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


Clinical Trial Manager, 858-240-1200,


University of Alabama at BirminghamRecruiting

Birmingham, Alabama

City of HopeRecruiting

Duarte, California

Stanford Cancer CenterRecruiting

Stanford, California

University of California, Los Angeles (UCLA) - Medical CenterRecruiting

Los Angeles, California

University of California, San Diego (UCSD) - Moores Cancer CenterRecruiting

La Jolla, California

University of Southern CaliforniaRecruiting

Los Angeles, California

AdventHealth OrlandoRecruiting

Orlando, Florida

Moffitt Cancer CenterRecruiting

Tampa, Florida

Emory UniversityRecruiting

Atlanta, Georgia

The University of Chicago Medical Center (UCMC)Recruiting

Chicago, Illinois

University of IowaRecruiting

Iowa City, Iowa

Tulane University Medical CenterRecruiting

New Orleans, Louisiana

University of Maryland Medical CenterRecruiting

Baltimore, Maryland

Beth Israel Deaconess Medical CenterRecruiting

Boston, Massachusetts

Dana-Farber Cancer InstituteRecruiting

Boston, Massachusetts

Henry Ford HospitalRecruiting

Detroit, Michigan

Spectrum HealthRecruiting

Grand Rapids, Michigan

Mayo Clinic - RochesterRecruiting

Rochester, Minnesota

John Theurer Cancer Center At Hackensack UMCRecruiting

Hackensack, New Jersey

Rutgers Cancer Institute of NJRecruiting

New Brunswick, New Jersey

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterRecruiting

New York, New York

Northwell HealthRecruiting

Lake Success, New York

Stony Brook University Medical CenterRecruiting

Stony Brook, New York

University of North Carolina (UNC)Recruiting

Chapel Hill, North Carolina

Wake ForestRecruiting

Winston-Salem, North Carolina

Oncology Hematology in CincinnatiRecruiting

Cincinnati, Ohio

The Ohio State University (OSU)Recruiting

Columbus, Ohio

University Hospitals Cleveland Medical CenterRecruiting

Cleveland, Ohio

Oregon Health & Science University (OHSU)Recruiting

Portland, Oregon

University of Pennsylvania Abramson Cancer CenterRecruiting

Philadelphia, Pennsylvania

University of Pittsburgh Medical Center (UPMC) - Hillman Cancer CenterRecruiting

Pittsburgh, Pennsylvania

Sarah Cannon Research Institute, LLC (SCRI)Recruiting

Nashville, Tennessee

Baylor Scott & White Research InstituteRecruiting

Dallas, Texas

Fred Hutchinson Cancer Research CenterRecruiting

Seattle, Washington record

NCT05263999. First posted on 3/3/22

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