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ACTIVE NOT RECRUITING
NCT03475212
PHASE1/PHASE2

Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation

Sponsor: Pediatric Transplantation & Cellular Therapy Consortium

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate whether virus-specific T cell lines (VSTs) are safe and can effectively control three viruses (EBV, CMV, and adenovirus) in patients who have had a stem cell transplant and also in patients that have a primary immunodeficiency disorder with no prior stem cell transplant.

Official title: Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation (ACES) PBMTC SUP1701

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2018-06-20

Completion Date

2025-06-30

Last Updated

2025-05-11

Healthy Volunteers

No

Interventions

BIOLOGICAL

Virus Specific T-cell (VST) infusion

Patients will receive partially HLA-matched VSTs as a single infusion. Patients who have a partial response (\>1 log decrease in viral load without clearance) or no response and do not have treatment-related dose-limiting toxicities are eligible to receive up to 3 additional doses from day 30 after the initial infusion and at 2 weekly intervals thereafter. The viral load of the virus (or viruses) that patients are initially treated for are monitored by viral PCR.

Locations (30)

Phoenix Children's Hospital

Phoenix, Arizona, United States

City of Hope

Duarte, California, United States

University of California, Los Angeles

Los Angeles, California, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Stanford Lucile Packard Children's Hospital

Palo Alto, California, United States

UCSF Medical Center

San Francisco, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Yale

New Haven, Connecticut, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Emory University/Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Riley Hospital for Children - Indiana University

Indianapolis, Indiana, United States

Tufts Medical Center

Boston, Massachusetts, United States

Dana-Farber Cancer Institute/ Boston Children's Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Spectrum Health - Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University

St Louis, Missouri, United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, United States

Columbia University Medical Center

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

Oregon Health & Science University

Portland, Oregon, United States

The Children's Hospital

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

St. Jude

Memphis, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Children's Mercy

San Antonio, Texas, United States

Methodist Healthcare System of San Antonio

San Antonio, Texas, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Fred Hutchinson Cancer Research Center/Seattle Chlindren's/University of Washington School of Medicine

Seattle, Washington, United States