Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
- Conditions
- Epstein-Barr Virus InfectionsHuman Herpes Virus-6 InfectionJC Virus InfectionCytomegalovirus InfectionsAdenovirus InfectionBK Virus Infection
- Interventions
- Biological: Posoleucel (ALVR105)Biological: Placebo
- Registration Number
- NCT05305040
- Lead Sponsor
- AlloVir
- Brief Summary
This is a Phase 3 study to evaluate posoleucel (ALVR105, 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, 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 451
-
Any age at the day of screening visit.
-
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)
Key
- History of AdV, BKV, CMV, EBV, HHV-6, and/or JCV end-organ disease within 6 months prior to randomization
- 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Posoleucel (ALVR105) Posoleucel (ALVR105) Administered as 2-4 milliliter infusion, visually identical to placebo Placebo Placebo Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
- Primary Outcome Measures
Name Time Method Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 14 Through Week 14 The average number of clinically significant infections or episodes of end-organ disease per participant due to Adenovirus (AdV), BK virus (BKV), Cytomegalovirus (CMV), Epstein-Barr virus (EBV), Human herpes virus 6 (HHV-6), or JC virus (JCV).
- Secondary Outcome Measures
Name Time Method Number of Participants With Clinically Significant Infections or Episodes of End-Organ Disease Due to Each Virus Through Week 14 The number of participants with clinically significant infections or episodes of end-organ disease due to each of the following viruses: AdV, BKV, CMV, EBV, HHV-6, or JCV.
Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 26 Through Week 26 The number of clinically significant infections or episodes of end-organ disease per participant due to AdV, BKV, CMV, EBV, HHV-6, or JCV.
Trial Locations
- Locations (88)
Northside Hospital
🇺🇸Atlanta, Georgia, United States
Institut Jules Bordet and the Childrens Hospital
🇧🇪Bruxelles, Belgium
A.Z. Sint-Jan Brugge Oostende AV
🇧🇪Brugge, Belgium
Indiana University Hospital Simon Comprehensive Cancer Center
🇺🇸Indianapolis, Indiana, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Dana-Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Honor Health Research Institute
🇺🇸Scottsdale, Arizona, United States
University of California, Los Angeles (UCLA)
🇺🇸Los Angeles, California, United States
City of Hope
🇺🇸Duarte, California, United States
Stanford University
🇺🇸Palo Alto, California, United States
Childrens National Health System
🇺🇸Washington, District of Columbia, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
University of Kansas Hospital
🇺🇸Kansas City, Kansas, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Washington University School of Medicine
🇺🇸Saint 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
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
Royal Melbourne Hospital
🇦🇺Parkville, Australia
Westmead Hospital
🇦🇺Westmead, Australia
Austin Health
🇦🇺Heidelberg, Australia
Royal Brisbane and Women's Hospital
🇦🇺Herston, Australia
Royal Adelaide Hospital
🇦🇺Adelaide, Australia
Queensland Children's Hospital
🇦🇺South Brisbane, Australia
Cellular Therapy Program - CHU Sainte-Justine (McGill)
🇨🇦Montréal, Canada
University Hospital Gasthuisberg and Leuven
🇧🇪Leuven, Belgium
Leukemia/ BMT Program of British Columbia - Vancouver General Hospital
🇨🇦Vancouver, Canada
Centre Hospitalier Regional Universitaire de Lille
🇫🇷Lille, France
Alberta Children's Hospital
🇨🇦Calgary, Canada
UHN Blood and Marrow Transplant (BMT) Program (Princess Margaret) Cancer Center
🇨🇦Toronto, Canada
The Hospital for Sick Children Blood & Marrow Transplant / Cellular Therapy Program
🇨🇦Toronto, Canada
CHU de Nantes
🇫🇷Nantes, France
IUCT-Oncopole
🇫🇷Toulouse, France
Ospedale San Raffaele
🇮🇹Milan, Italy
Fondazione I.R.C.C.S. Policlinico San Matteo
🇮🇹Pavia, Italy
IRCSS Ospedale Pediatrico Bambino Gesu
🇮🇹Roma, Italy
Hopital Saint Antoine
🇫🇷Paris, France
Hopital Universitaire Robert Debre
🇫🇷Paris, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre-Bénite, France
Azienda Ospedaliero-Universitaria Careggi
🇮🇹Firenze, Italy
University of Sacred Heart Policlinico A. Gemelli
🇮🇹Rome, Italy
Humanitas Cancer Center
🇮🇹Rozzano, Italy
Azienda Ospedaliera Universitaria Integrata Verona (AOUI)
🇮🇹Verona, Italy
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Institut Catala d'Oncologia
🇪🇸Barcelona, Spain
Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Regional Universitario de Malaga
🇪🇸Málaga, Spain
Acibadem Adana Hospital
🇹🇷Adana, Turkey
Hospital Universitari i Politecnic La Fe de Valencia
🇪🇸Valencia, Spain
Baskent Adana Hospital
🇹🇷Adana, Turkey
Ankara Onkoloji Egitim Ve Arastirma Hastanesi
🇹🇷Ankara, Turkey
Gazi University Medical Faculty Hospital
🇹🇷Ankara, Turkey
Medical Park Hospital
🇹🇷Antalya, Turkey
Ege University Medical Faculty
🇹🇷Izmir, Turkey
Anadolu Medical Center Hospital
🇹🇷Kocaeli, Turkey
Bristol Haematology and Oncology Centre
🇬🇧Bristol, United Kingdom
Queen Elizabeth University Hospital - Glasgow
🇬🇧Glasgow, United Kingdom
Inonu University Turgut Özal Medical Centre
🇹🇷Malatya, Turkey
Great Ormond Street Hospital for Children
🇬🇧London, United Kingdom
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
University Hospitals Bristol - Bristol Hospital for Children
🇬🇧Bristol, United Kingdom
Hopital Maisonneve Rosemont
🇨🇦Montréal, Canada
Ankara University Hospital
🇹🇷Ankara, Turkey
AP-HP Hopital Saint-Louis
🇫🇷Paris, France
Children's Medical Center Dallas
🇺🇸Dallas, Texas, United States
University of Alabama at Birmingham Children's of Alabama
🇺🇸Birmingham, Alabama, United States
University of California San Francisco - Benioff Children's Hospital
🇺🇸San Francisco, California, United States
University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Moffitt Cancer Center
🇺🇸Tampa, Florida, United States
University of Utah/Primary Childrens Hospital
🇺🇸Salt Lake City, Utah, United States
Froedtert Hospital and the Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Yale University School of Medicine - Yale Cancer Center
🇺🇸New Haven, Connecticut, United States
University of Florida (UF) - Gainesville
🇺🇸Gainesville, Florida, United States
Children's Mercy Hospital
🇺🇸Kansas City, Missouri, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States