Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant (Prevent)

April 19, 2024 updated by: AlloVir

Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 Posoleucel (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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

451

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
        • Royal Adelaide Hospital
      • Heidelberg, Australia
        • Austin Health
      • Herston, Australia
        • Royal Brisbane and Women's Hospital
      • Parkville, Australia
        • Royal Melbourne Hospital
      • South Brisbane, Australia
        • Queensland Children's Hospital
      • Westmead, Australia
        • Westmead Hospital
  • Belgium
      • Brugge, Belgium
        • A.Z. Sint-Jan Brugge Oostende AV
      • Bruxelles, Belgium
        • Institut Jules Bordet and the Childrens Hospital
      • Leuven, Belgium
        • University Hospital Gasthuisberg and Leuven
  • Canada
      • Calgary, Canada
        • Alberta Children's Hospital
      • Montréal, Canada
        • Cellular Therapy Program - CHU Sainte-Justine (McGill)
      • Montréal, Canada
        • Hopital Maisonneve Rosemont
      • Toronto, 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
      • Vancouver, Canada
        • Leukemia/ BMT Program of British Columbia - Vancouver General Hospital
  • France
      • Lille, France
        • Centre Hospitalier Regional Universitaire de Lille
      • Nantes, France
        • CHU de Nantes
      • Paris, France
        • Hopital Saint Antoine
      • Paris, France
        • AP-HP Hopital Saint-Louis
      • Paris, France
        • Hopital Universitaire Robert Debre
      • Pierre-Bénite, France
        • Centre Hospitalier Lyon Sud
      • Toulouse, France
        • IUCT-Oncopole
  • Italy
      • Firenze, Italy
        • Azienda Ospedaliero-Universitaria Careggi
      • Milan, Italy
        • Ospedale San Raffaele
      • Pavia, Italy
        • Fondazione I.R.C.C.S. Policlinico San Matteo
      • Roma, Italy
        • IRCSS Ospedale Pediatrico Bambino Gesu
      • Rome, Italy
        • University of Sacred Heart Policlinico A. Gemelli
      • Rozzano, Italy
        • Humanitas Cancer Center
      • Verona, Italy
        • Azienda Ospedaliera Universitaria Integrata Verona (AOUI)
  • Korea, Republic of
      • Busan, Korea, Republic of
        • Pusan National University Hospital
      • Hwasun, Korea, Republic of
        • Chonnam National University Hwasun Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of
        • Severance Hospital, Yonsei University Health System
  • Spain
      • Barcelona, Spain
        • Institut Catala d'Oncologia
      • Madrid, Spain
        • Hospital General Universitario Gregorio Marañón
      • Málaga, Spain
        • Hospital Regional Universitario de Málaga
      • Valencia, Spain
        • Hospital Universitari i Politecnic La Fe de Valencia
  • Turkey
      • Adana, Turkey
        • Acibadem Adana Hospital
      • Adana, Turkey
        • Baskent Adana Hospital
      • Ankara, Turkey
        • Ankara Onkoloji Egitim Ve Arastirma Hastanesi
      • Ankara, Turkey
        • Ankara University Hospital
      • Ankara, Turkey
        • Gazi University Medical Faculty Hospital
      • Antalya, Turkey
        • Medical Park Hospital
      • Izmir, Turkey
        • Ege University Medical Faculty
      • Kocaeli, Turkey
        • Anadolu Medical Center Hospital
      • Malatya, Turkey
        • Inonu University Turgut Özal Medical Centre
  • United Kingdom
      • Bristol, United Kingdom
        • Bristol Haematology and Oncology Centre
      • Bristol, United Kingdom
        • University Hospitals Bristol - Bristol Hospital for Children
      • Cambridge, United Kingdom
        • Addenbrooke's Hospital
      • Glasgow, United Kingdom
        • Queen Elizabeth University Hospital - Glasgow
      • London, United Kingdom
        • Great Ormond Street Hospital for Children
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham Children's of Alabama
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Honor Health Research Institute
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • Los Angeles, California, United States, 90095
        • University of California, Los Angeles (UCLA)
      • Palo Alto, California, United States, 94304
        • Stanford University
      • San Francisco, California, United States, 94143
        • University of California San Francisco - Benioff Children's Hospital
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Hospital
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School of Medicine - Yale Cancer Center
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Childrens National Health System
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida (UF) - Gainesville
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Northside Hospital
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Hospital Simon Comprehensive Cancer Center
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University Of Kansas Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • New York
      • Buffalo, New York, United States, 14263
        • Roswell Park Cancer Institute
      • New York, New York, United States, 10065
        • Weill Cornell Medical College
      • New York, New York, United States, 10032
        • Columbia University
      • Stony Brook, New York, United States, 11794
        • Stony Brook University Hospital Cancer Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center/Levine
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Texas
      • Dallas, Texas, United States, 75235
        • Children's Medical Center Dallas
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • University of Utah/Primary Childrens Hospital
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital and the Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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 Exclusion Criteria:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Biological: Placebo
Administered as 2-4 milliliter infusion, visually identical to Posoleucel (ALVR105)
Experimental: Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion, visually identical to placebo
Biological: Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion, visually identical to placebo
Other Names:
  • Viralym-M

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 14
Time Frame: 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).
Through Week 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Number of Clinically Significant Infections or Episodes of End-Organ Disease Through Week 26
Time Frame: 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.
Through Week 26
Number of Participants With Clinically Significant Infections or Episodes of End-Organ Disease Due to Each Virus
Time Frame: 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.
Through Week 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AlloVir

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 24, 2022

Primary Completion (Actual)

January 30, 2024

Study Completion (Actual)

January 30, 2024

Study Registration Dates

First Submitted

March 22, 2022

First Submitted That Met QC Criteria

March 30, 2022

First Posted (Actual)

March 31, 2022

Study Record Updates

Last Update Posted (Estimated)

May 15, 2024

Last Update Submitted That Met QC Criteria

April 19, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-105-202 Phase 3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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