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Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation

Primary Purpose

Adenovirus Infection

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Posoleucel
Placebo
Sponsored by
AlloVir
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adenovirus Infection focused on measuring Allogeneic Hematopoietic Cell Transplant, Adenoviremia, Adenovirus, Stem Cell Transplant, Posoleucel, ALVR105, Bone Marrow Transplant

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female >1 year of age.

  • Has undergone allogeneic cell transplantation ≥21 days prior to randomization and demonstrated engraftment with an absolute neutrophil count >500/mm^3, AND has one of the following:

    1. AdV viremia DNA ≥10,000 copies/mL at screening, OR

    2. Two consecutive and rising AdV viremia DNA results of ≥1,000 copies/mL at screening, AND

      1. has absolute lymphocyte count <180/mm3, OR
      2. has received T cell depletion.
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and refrain from donating sperm or eggs for at least 90 days after treatment completion.
  • Willing and able to provide signed informed consent.
  • Has an HLA type matching with at least 1 suitably matched and available posoleucel VST line for infusion.

Exclusion Criteria:

  • Grade >2 acute GVHD
  • Ongoing therapy with high-dose systemic corticosteroids
  • Grade 4 diarrhea
  • Uncontrolled viral (other than AdV), bacterial, or fungal infection(s)
  • Requirement for fraction of inspired oxygen >0.5 to maintain arterial oxygen saturation >90% (via pulse oximetry) or need for mechanical ventilation.
  • Prior therapy with anti-thymocyte globulin, alemtuzumab (Campath®), or other immunosuppressive T cell monoclonal antibodies within 28 days prior to randomization.
  • Prior donor lymphocyte infusion or CD34+ stem cell infusion within 21 days prior to randomization.
  • Use of vasopressors within 7 days prior to randomization.
  • Use of any investigational antiviral agent, including brincidofovir, within 7 days prior to randomization.
  • Lactating female unwilling to discontinue nursing prior to randomization.
  • Severe allergy to any component of posoleucel or history of severe prior reactions to blood product transfusions.
  • Positive for SARS-CoV-2 virus at screening.

Sites / Locations

  • MD Anderson Cancer CenterRecruiting
  • Phoenix Children's HospitalRecruiting
  • City of HopeRecruiting
  • University of California, Los Angeles (UCLA)Recruiting
  • Lucile Packard Children's Hospital - Stanford UniversityRecruiting
  • University of California, San Diego - Rady Children's HospitalRecruiting
  • Children's Hospital Colorado - Center for Cancer and Blood DisordersRecruiting
  • Children's National Medical CenterRecruiting
  • University of Florida (UF) - GainesvilleRecruiting
  • Ann and Robert H. Lurie Children's Hospital of ChicagoRecruiting
  • Dana-Farber Cancer InstituteRecruiting
  • University of MinnesotaRecruiting
  • Washington University School of Medicine in St. LouisRecruiting
  • Hackensack University Medical CenterRecruiting
  • New York Presbyterian HospitalRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Duke University Medical CenterRecruiting
  • Cleveland ClinicRecruiting
  • University of OklahomaRecruiting
  • University of Texas SouthwesternRecruiting
  • Cook Children's Medical CenterRecruiting
  • Intermountain HealthCare - Primary Children's HospitalRecruiting
  • Seattle Children's HospitalRecruiting
  • The Hospital for Sick Children (SickKids)Recruiting
  • CHU Sainte-JustineRecruiting
  • IRCCS Ospedale San RaffaeleRecruiting
  • Fondazione IRCCS San Gerardo dei TintoriRecruiting
  • A.O.R.N. Santobono-PausiliponRecruiting
  • Azienda Ospedaliera di PadovaRecruiting
  • Fondazione IRCCS Policlinico San MatteoRecruiting
  • Ospedale Pediatrico Bambino GesùRecruiting
  • Ospedale Regina MargheritaRecruiting
  • Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo TrentoRecruiting
  • Hospital Universitario Vall d'HebronRecruiting
  • Hospital Universitario La PazRecruiting
  • Hospital Universitari i Politecnic La FeRecruiting
  • Sahlgrenska University HospitalRecruiting
  • Skane University Hospital LundRecruiting
  • Karolinska University HospitalRecruiting
  • Birmingham Children's HospitalRecruiting
  • Bristol Royal Hospital for ChildrenRecruiting
  • Royal Hospital for Children - GlasgowRecruiting
  • University College London HospitalRecruiting
  • St. Mary's Hospital, PaddingtonRecruiting
  • Great Ormond Street Hospital for ChildrenRecruiting
  • Royal Manchester Children's HospitalRecruiting
  • Sheffield Children's NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Posoleucel + SoC

Placebo + SoC

Arm Description

Posoleucel + SOC; then placebo + SOC for patients who meet optional protocol-defined crossover criteria

Placebo + SOC; then Posoleucel + SOC for patients who meet optional protocol-defined crossover criteria

Outcomes

Primary Outcome Measures

Proportion of participants with undetectable adenovirus infection
Primary Efficacy
Incidence and severity of treatment-emergent adverse events (TEAEs)
Primary Safety

Secondary Outcome Measures

Overall disease progression or non-relapse mortality
Key Secondary Efficacy
Mean area under the curve (AUC) AdV viral load
Other Secondary Efficacy
Proportion of participants who achieve AdV viremia <400 copies/mL
Other Secondary Efficacy
Time to undetectable AdV viremia (less than LLOQ)
Other Secondary Efficacy
Incidence of AdV disease recurrence
Other Secondary Efficacy

Full Information

First Posted
December 17, 2021
Last Updated
October 17, 2023
Sponsor
AlloVir
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1. Study Identification

Unique Protocol Identification Number
NCT05179057
Brief Title
Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
Official Title
Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial, With Cross-Over, of Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2022 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
June 2024 (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 study will assess the safety and efficacy of Posoleucel for the treatment of adenovirus (AdV) infection in pediatric and adult allo-HCT recipients receiving standard of care (SoC).
Detailed Description
During the period of immune recovery after allogeneic hematopoietic cell transplant (allo-HCT), viral infections and reactivations, including those with AdV, are an important cause of morbidity and mortality. Progression to AdV disease is associated with significant morbidity and mortality rates. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study will assess the safety and efficacy of Posoleucel for the treatment of AdV infection in pediatric and adult allo-HCT recipients receiving SoC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adenovirus Infection
Keywords
Allogeneic Hematopoietic Cell Transplant, Adenoviremia, Adenovirus, Stem Cell Transplant, Posoleucel, ALVR105, Bone Marrow Transplant

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study with option for blinded crossover to assess the safety and efficacy of posoleucel as compared to placebo for the treatment of AdV infection in pediatric and adult recipients of HCT with AdV infections receiving SoC.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Posoleucel + SoC
Arm Type
Experimental
Arm Description
Posoleucel + SOC; then placebo + SOC for patients who meet optional protocol-defined crossover criteria
Arm Title
Placebo + SoC
Arm Type
Placebo Comparator
Arm Description
Placebo + SOC; then Posoleucel + SOC for patients who meet optional protocol-defined crossover criteria
Intervention Type
Drug
Intervention Name(s)
Posoleucel
Intervention Description
Administered as 2-4 milliliter infusion, visually identical to placebo
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered as 2-4 milliliter infusion, visually identical to Posoleucel
Primary Outcome Measure Information:
Title
Proportion of participants with undetectable adenovirus infection
Description
Primary Efficacy
Time Frame
29 days
Title
Incidence and severity of treatment-emergent adverse events (TEAEs)
Description
Primary Safety
Time Frame
34 weeks
Secondary Outcome Measure Information:
Title
Overall disease progression or non-relapse mortality
Description
Key Secondary Efficacy
Time Frame
34 weeks
Title
Mean area under the curve (AUC) AdV viral load
Description
Other Secondary Efficacy
Time Frame
29 days
Title
Proportion of participants who achieve AdV viremia <400 copies/mL
Description
Other Secondary Efficacy
Time Frame
29 days
Title
Time to undetectable AdV viremia (less than LLOQ)
Description
Other Secondary Efficacy
Time Frame
34 weeks
Title
Incidence of AdV disease recurrence
Description
Other Secondary Efficacy
Time Frame
34 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Undergone allogeneic cell transplantation ≥21 days prior to dosing Meet one of the below criteria: AdV viremia DNA ≥10,000 copies/mL, OR AdV viremia DNA results of ≥1,000 copies/mL, AND has absolute lymphocyte count <180/mm3, OR has received T cell depletion OR had a cord blood transplant. Exclusion Criteria: Grade 3 or higher acute GVHD Ongoing therapy with high-dose systemic corticosteroids Uncontrolled viral (other than AdV), bacterial, or fungal infection(s) Pregnant or lactating female unwilling to discontinue nursing prior to randomization History of severe prior reactions to blood product transfusions NOTE: Other protocol-defined inclusion/exclusion criterion may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chrissy Pelland
Phone
+1 833-409-2281
Email
ClinicalTrials@allovir.com
Facility Information:
Facility Name
MD Anderson Cancer Center
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85234
Country
United States
Individual Site Status
Recruiting
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, Los Angeles (UCLA)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Name
Lucile Packard Children's Hospital - Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California, San Diego - Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital Colorado - Center for Cancer and Blood Disorders
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Florida (UF) - Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Recruiting
Facility Name
Ann and Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University School of Medicine in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Oklahoma
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Individual Site Status
Recruiting
Facility Name
Intermountain HealthCare - Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
81432
Country
United States
Individual Site Status
Recruiting
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Individual Site Status
Recruiting
Facility Name
The Hospital for Sick Children (SickKids)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Name
CHU Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Individual Site Status
Recruiting
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS San Gerardo dei Tintori
City
Monza
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O.R.N. Santobono-Pausilipon
City
Napoli
ZIP/Postal Code
80123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione IRCCS Policlinico San Matteo
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Pediatrico Bambino Gesù
City
Roma
ZIP/Postal Code
165
Country
Italy
Individual Site Status
Recruiting
Facility Name
Ospedale Regina Margherita
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento
City
Verona
ZIP/Postal Code
1-37126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politecnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Sahlgrenska University Hospital
City
Gothenburg
ZIP/Postal Code
41685
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Skane University Hospital Lund
City
Lund
ZIP/Postal Code
221 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Karolinska University Hospital
City
Solna
ZIP/Postal Code
171 64
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Birmingham Children's Hospital
City
Birmingham
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Bristol Royal Hospital for Children
City
Bristol
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Hospital for Children - Glasgow
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
University College London Hospital
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
St. Mary's Hospital, Paddington
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Great Ormond Street Hospital for Children
City
London
ZIP/Postal Code
WC1n 3JH
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Royal Manchester Children's Hospital
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Sheffield Children's NHS Foundation Trust
City
Sheffield
ZIP/Postal Code
S10 2TH
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Posoleucel (ALVR105) for the Treatment of Adenovirus Infection in Pediatric and Adult Participants Receiving Standard of Care Following Allogeneic Hematopoietic Cell Transplantation

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