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

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

June 20, 2018

Primary Completion Date

June 30, 2025

Study Completion Date

June 30, 2025

Conditions
Cytomegalovirus InfectionsAdenovirus InfectionEBV Infection
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.

Trial Locations (30)

10032

Columbia University Medical Center, New York

14263

Roswell Park Comprehensive Cancer Center, Buffalo

19104

The Children's Hospital, Philadelphia

20010

Children's National Medical Center, Washington D.C.

23298

Virginia Commonwealth University, Richmond

27705

Duke University Medical Center, Durham

29425

Medical University of South Carolina, Charleston

30322

Emory University/Children's Healthcare of Atlanta, Atlanta

38105

St. Jude, Memphis

46202

Riley Hospital for Children - Indiana University, Indianapolis

48109

University of Michigan, Ann Arbor

49503

Spectrum Health - Helen DeVos Children's Hospital, Grand Rapids

55455

University of Minnesota, Minneapolis

60611

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

63110

Washington University, St Louis

75390

UT Southwestern Medical Center, Dallas

78229

Children's Mercy, San Antonio

Methodist Healthcare System of San Antonio, San Antonio

80045

Children's Hospital Colorado, Aurora

85016

Phoenix Children's Hospital, Phoenix

90095

University of California, Los Angeles, Los Angeles

91010

City of Hope, Duarte

91016

Children's Hospital Los Angeles, Los Angeles

94123

UCSF Medical Center, San Francisco

94304

Stanford Lucile Packard Children's Hospital, Palo Alto

97239

Oregon Health & Science University, Portland

98109

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

06520

Yale, New Haven

02111

Tufts Medical Center, Boston

02215

Dana-Farber Cancer Institute/ Boston Children's Hospital, Boston

All Listed Sponsors
lead

Pediatric Transplantation & Cellular Therapy Consortium

OTHER

NCT03475212 - Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation | Biotech Hunter | Biotech Hunter