Spots Global Cancer Trial Database for Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
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Trial Identification
Brief Title: Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
Official Title: Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 (Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6, and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant
Study ID: NCT04693637
Interventions
Study Description
Brief Summary: This is a Phase 2 study to evaluate posoleucel (ALVR105, formerly Viralym-M); an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets six viral pathogens: BK virus, cytomegalovirus, adenovirus, Epstein-Barr virus, human herpesvirus 6 and JC virus.
Detailed Description: This is a Phase 2/3, multicenter, randomized, double-blind, placebo controlled trial comparing posoleucel to placebo for the prevention of infection or disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV in high-risk adult and pediatric patients after allogeneic HCT. There are 2 parts to the study, an open label Phase 2 cohort described in this posting, and a randomized, placebo controlled Phase 3 cohort described in NCT05305040. In the Phase 2 part, 25 to 35 eligible allogeneic HCT recipients will be enrolled and will receive 7 doses of posoleucel over 12 weeks, followed by a 14 week follow-up period.
Eligibility
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
City of Hope National Medical Center, Duarte, California, United States
University of California, San Francisco Medical Center, San Francisco, California, United States
Childrens National Medical Center, Northwest Rectangle, District of Columbia, United States
Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, Indiana, United States
University of Kansas Hospital, Westwood, Kansas, United States
University of Maryland Medical Center, Baltimore, Maryland, United States
The Johns Hopkins Hospital, Baltimore, Maryland, United States
University of Minnesota, Minneapolis, Minnesota, United States
Children's Mercy Kansas City, Kansas City, Missouri, United States
Weill Cornell Medical College, New York, New York, United States
Stony Brook University Hospital Cancer Center, Stony Brook, New York, United States
Nationwide Children's Hospital, Columbus, Ohio, United States
Children's Medical Center Dallas, Dallas, Texas, United States
University of Virginia, Charlottesville, Virginia, United States
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
Contact Details
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