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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04693637
Recruitment Status : Active, not recruiting
First Posted : January 5, 2021
Last Update Posted : May 5, 2022
Sponsor:
Information provided by (Responsible Party):
AlloVir

Study Description
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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.

Condition or disease Intervention/treatment Phase
Adenovirus Infection BK Virus Infection Cytomegalovirus Infections Epstein-Barr Virus Infections Human Herpes Virus-6 Infection JC Virus Infection Biological: Posoleucel (ALVR105) Phase 2 Phase 3

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : January 15, 2021
Estimated Primary Completion Date : August 1, 2022
Estimated Study Completion Date : March 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion
 Biological: Posoleucel (ALVR105)
Administered as 2-4 milliliter infusion


Outcome Measures
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Primary Outcome Measures :
  1. Number of clinically significant infections or episodes of end-organ disease [ Time Frame: Through Week 14 ]

Secondary Outcome Measures :
  1. Number of clinically significant infections or episodes of end-organ disease [ Time Frame: Through Week 26 ]
  2. Number of clinically significant infections or episodes of end-organ disease due to each virus [ Time Frame: Through Weeks 14 and 26 ]
  3. Mean area under the curve (AUC) viral load [ Time Frame: Through Weeks 14 and 26 ]
  4. Incidence of Adverse Events [ Time Frame: Through Week 26 ]
  5. Rates of Overall and Non-Relapse Mortality [ Time Frame: Through Week 26 ]

Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria

  • ≥1 year of age at the day of screening visit.
  • Either no evidence of viral infection or viremia, or asymptomatic, viral infection with 3 or fewer viruses of interest at time of screening
  • Within 15 and 42 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment

  • 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
    • Unrelated donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B, -C, or -DR
    • Use of umbilical cord blood as stem cell source
    • Ex vivo graft manipulation resulting in T cell depletion
    • Lymphocyte Count <180/mm3 and/or cluster of differentiation 4 (CD4) Count <50/mm3

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 CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies
  • Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose >0.5 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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04693637


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
University of California, San Francisco Medical Center
San Francisco, California, United States, 94143
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Hospital
Westwood, Kansas, United States, 66205
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Children's Mercy Kansas City
Kansas City, Missouri, United States, 64108
United States, New York
Stony Brook University Hospital Cancer Center
Stony Brook, New York, United States, 11794
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Texas
Children's Medical Center Dallas
Dallas, Texas, United States, 75235
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
AlloVir
More Information
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Publications:
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.

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Responsible Party: AlloVir
ClinicalTrials.gov Identifier: NCT04693637    
Other Study ID Numbers: P-105-202 Phase 2
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AlloVir:
Allogeneic Hematopoietic Cell Transplant
Posoleucel
ALVR105
Viralym-M
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Virus Diseases
Adenoviridae Infections
Cytomegalovirus Infections
Epstein-Barr Virus Infections
 Disease Attributes
Pathologic Processes
DNA Virus Infections
Herpesviridae Infections
Tumor Virus Infections