Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
NCT ID: NCT05305040
Last Updated: 2024-05-16
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2/PHASE3
451 participants
INTERVENTIONAL
2022-03-24
2024-01-30
Brief Summary
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Detailed Description
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There are 2 parts to the study, a Phase 3 randomized study cohort described in this posting, and an open label Phase 2 cohort described in NCT04693637, which has completed enrollment. In this Phase 3 part, approximately 302 eligible allogeneic HCT recipients will be enrolled and will receive 7 doses of posoleucel or placebo over 12 weeks, followed by a 12 week follow-up period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion, visually identical to placebo
Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion, visually identical to placebo
Placebo
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Placebo
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Interventions
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Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion, visually identical to placebo
Placebo
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* No known or suspected clinically significant disease from AdV, BKV, CMV, EBV, HHV-6, and/or JCV
* Within 25 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment at time of dosing
* Meet one or more of the following criteria at the time of randomization:
* Related (sibling) donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B or -DR
* Haploidentical donor
* Matched or Mismatched unrelated donor
* Use of umbilical cord blood as stem cell source
* Ex vivo graft manipulation resulting in T cell depletion
* Received anti-thymocyte globulin or alemtuzumab (Campath-1H)
Exclusion Criteria
* Evidence of active Grade \>2 acute GVHD
* Presence of non-minor uncontrolled or progressive bacterial, viral or fungal infections
* Known history or current (suspected) diagnosis of Grade ≥3 CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies
* Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose \>1.0 mg/kg/day) within 24 hours prior to dosing
* Relapse of primary malignancy other than minimal residual disease
ALL
No
Sponsors
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AlloVir
INDUSTRY
Responsible Party
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Locations
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University of Alabama at Birmingham Children's of Alabama
Birmingham, Alabama, United States
Honor Health Research Institute
Scottsdale, Arizona, United States
City of Hope
Duarte, California, United States
University of California, Los Angeles (UCLA)
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
University of California San Francisco - Benioff Children's Hospital
San Francisco, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Yale University School of Medicine - Yale Cancer Center
New Haven, Connecticut, United States
Childrens National Health System
Washington D.C., District of Columbia, United States
University of Florida (UF) - Gainesville
Gainesville, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Northside Hospital
Atlanta, Georgia, United States
Loyola University Medical Center
Maywood, Illinois, United States
Indiana University Hospital Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States
University of Kansas Hospital
Kansas City, Kansas, United States
University of Maryland
Baltimore, Maryland, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
University of Minnesota
Minneapolis, Minnesota, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Columbia University
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
Stony Brook University Hospital Cancer Center
Stony Brook, New York, United States
Carolinas Medical Center/Levine
Charlotte, North Carolina, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Children's Medical Center Dallas
Dallas, Texas, United States
University of Utah/Primary Childrens Hospital
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Royal Adelaide Hospital
Adelaide, , Australia
Austin Health
Heidelberg, , Australia
Royal Brisbane and Women's Hospital
Herston, , Australia
Royal Melbourne Hospital
Parkville, , Australia
Queensland Children's Hospital
South Brisbane, , Australia
Westmead Hospital
Westmead, , Australia
A.Z. Sint-Jan Brugge Oostende AV
Bruges, , Belgium
Institut Jules Bordet and the Childrens Hospital
Brussels, , Belgium
University Hospital Gasthuisberg and Leuven
Leuven, , Belgium
Alberta Children's Hospital
Calgary, , Canada
Cellular Therapy Program - CHU Sainte-Justine (McGill)
Montreal, , Canada
Hopital Maisonneve Rosemont
Montreal, , Canada
The Hospital for Sick Children Blood & Marrow Transplant / Cellular Therapy Program
Toronto, , Canada
UHN Blood and Marrow Transplant (BMT) Program (Princess Margaret) Cancer Center
Toronto, , Canada
Leukemia/ BMT Program of British Columbia - Vancouver General Hospital
Vancouver, , Canada
Centre Hospitalier Regional Universitaire de Lille
Lille, , France
CHU de Nantes
Nantes, , France
AP-HP Hopital Saint-Louis
Paris, , France
Hopital Saint Antoine
Paris, , France
Hopital Universitaire Robert Debre
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
IUCT-Oncopole
Toulouse, , France
Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Ospedale San Raffaele
Milan, , Italy
Fondazione I.R.C.C.S. Policlinico San Matteo
Pavia, , Italy
IRCSS Ospedale Pediatrico Bambino Gesu
Roma, , Italy
University of Sacred Heart Policlinico A. Gemelli
Rome, , Italy
Humanitas Cancer Center
Rozzano, , Italy
Azienda Ospedaliera Universitaria Integrata Verona (AOUI)
Verona, , Italy
Pusan National University Hospital
Busan, , South Korea
Chonnam National University Hwasun Hospital
Hwasun, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Seoul St. Mary's Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Institut Catala d'Oncologia
Barcelona, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Regional Universitario de Malaga
Málaga, , Spain
Hospital Universitari i Politecnic La Fe de Valencia
Valencia, , Spain
Acibadem Adana Hospital
Adana, , Turkey (Türkiye)
Baskent Adana Hospital
Adana, , Turkey (Türkiye)
Ankara Onkoloji Egitim Ve Arastirma Hastanesi
Ankara, , Turkey (Türkiye)
Ankara University Hospital
Ankara, , Turkey (Türkiye)
Gazi University Medical Faculty Hospital
Ankara, , Turkey (Türkiye)
Medical Park Hospital
Antalya, , Turkey (Türkiye)
Ege University Medical Faculty
Izmir, , Turkey (Türkiye)
Anadolu Medical Center Hospital
Kocaeli, , Turkey (Türkiye)
Inonu University Turgut Özal Medical Centre
Malatya, , Turkey (Türkiye)
Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
University Hospitals Bristol - Bristol Hospital for Children
Bristol, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Queen Elizabeth University Hospital - Glasgow
Glasgow, , United Kingdom
Great Ormond Street Hospital for Children
London, , United Kingdom
Countries
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References
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Posoleucel (ALVR105), an Off-the-Shelf, Multivirus-Specific T-Cell Therapy, for the Prevention of Viral Infections Post-HCT: Results from an Open-Label Cohort of a Phase 2 Trial Sanjeet S Dadwal, Michael Shuster, Gary Douglas Myers, Keith Boundy, Marshelle Warren, Elizabeth Stoner, Thuy Truong, Joshua A. Hill Blood (2021) 138 (Supplement 1): 1760.
Tzannou I, Papadopoulou A, Naik S, Leung K, Martinez CA, Ramos CA, Carrum G, Sasa G, Lulla P, Watanabe A, Kuvalekar M, Gee AP, Wu MF, Liu H, Grilley BJ, Krance RA, Gottschalk S, Brenner MK, Rooney CM, Heslop HE, Leen AM, Omer B. Off-the-Shelf Virus-Specific T Cells to Treat BK Virus, Human Herpesvirus 6, Cytomegalovirus, Epstein-Barr Virus, and Adenovirus Infections After Allogeneic Hematopoietic Stem-Cell Transplantation. J Clin Oncol. 2017 Nov 1;35(31):3547-3557. doi: 10.1200/JCO.2017.73.0655. Epub 2017 Aug 7.
Vasileiou S, Kuvalekar M, Velazquez Y, Watanabe A, Leen AM, Gilmore SA. Phenotypic and functional characterization of posoleucel, a multivirus-specific T cell therapy for the treatment and prevention of viral infections in immunocompromised patients. Cytotherapy. 2024 Aug;26(8):869-877. doi: 10.1016/j.jcyt.2024.03.012. Epub 2024 Mar 19.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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P-105-202 Phase 3
Identifier Type: -
Identifier Source: org_study_id
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