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

Primary Purpose

Adenovirus Infection, BK Virus Infection, Cytomegalovirus Infections

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Posoleucel (ALVR105)
Sponsored by
AlloVir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Adenovirus Infection focused on measuring Allogeneic Hematopoietic Cell Transplant, Posoleucel, ALVR105, Viralym-M

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • City of Hope National Medical Center
  • University of California, San Francisco Medical Center
  • Indiana University Melvin and Bren Simon Cancer Center
  • University of Kansas Hospital
  • University of Maryland Medical Center
  • University of Minnesota
  • Children's Mercy Kansas City
  • Stony Brook University Hospital Cancer Center
  • Nationwide Children's Hospital
  • Children's Medical Center Dallas
  • University of Virginia
  • Fred Hutchinson Cancer Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Posoleucel (ALVR105)

Arm Description

Administered as 2-4 milliliter infusion

Outcomes

Primary Outcome Measures

Number of clinically significant infections or episodes of end-organ disease

Secondary Outcome Measures

Number of clinically significant infections or episodes of end-organ disease
Number of clinically significant infections or episodes of end-organ disease due to each virus
Mean area under the curve (AUC) viral load
Incidence of Adverse Events
Rates of Overall and Non-Relapse Mortality

Full Information

First Posted
December 9, 2020
Last Updated
May 2, 2022
Sponsor
AlloVir
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1. Study Identification

Unique Protocol Identification Number
NCT04693637
Brief Title
Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
Acronym
Prevent
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 Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
March 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AlloVir

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenovirus Infection, BK Virus Infection, Cytomegalovirus Infections, Epstein-Barr Virus Infections, Human Herpes Virus-6 Infection, JC Virus Infection
Keywords
Allogeneic Hematopoietic Cell Transplant, Posoleucel, ALVR105, Viralym-M

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Posoleucel (ALVR105)
Arm Type
Experimental
Arm Description
Administered as 2-4 milliliter infusion
Intervention Type
Biological
Intervention Name(s)
Posoleucel (ALVR105)
Intervention Description
Administered as 2-4 milliliter infusion
Primary Outcome Measure Information:
Title
Number of clinically significant infections or episodes of end-organ disease
Time Frame
Through Week 14
Secondary Outcome Measure Information:
Title
Number of clinically significant infections or episodes of end-organ disease
Time Frame
Through Week 26
Title
Number of clinically significant infections or episodes of end-organ disease due to each virus
Time Frame
Through Weeks 14 and 26
Title
Mean area under the curve (AUC) viral load
Time Frame
Through Weeks 14 and 26
Title
Incidence of Adverse Events
Time Frame
Through Week 26
Title
Rates of Overall and Non-Relapse Mortality
Time Frame
Through Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
University of California, San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Kansas Hospital
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Children's Mercy Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Stony Brook University Hospital Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Children's Medical Center Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
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.
Results Reference
background
PubMed Identifier
28783452
Citation
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.
Results Reference
background

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

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