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

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

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).

Study Overview

• Status: Terminated
• Conditions: Adenovirus Infection
• Intervention / Treatment: Drug: Posoleucel; Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Chrissy Pelland; Phone Number: +1 833-409-2281; Email: ClinicalTrials@allovir.com

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children (SickKids)
  • Quebec
    • Montreal, Quebec, Canada, H3T 1C5
      • CHU Sainte-Justine
• Italy
  • Milano, Italy, 20132
    • IRCCS Ospedale San Raffaele
  • Monza, Italy, 20900
    • Fondazione IRCCS San Gerardo dei Tintori
  • Napoli, Italy, 80123
    • A.O.R.N. Santobono-Pausilipon
  • Padova, Italy, 35128
    • Azienda Ospedaliera di Padova
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo
  • Roma, Italy, 165
    • Ospedale Pediatrico Bambino Gesu
  • Torino, Italy, 10126
    • Ospedale Regina Margherita
  • Verona, Italy, 1-37126
    • Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
• Sweden
  • Gothenburg, Sweden, 41685
    • Sahlgrenska University Hospital
  • Lund, Sweden, 221 85
    • Skane University Hospital Lund
  • Solna, Sweden, 171 64
    • Karolinska University Hospital
• United Kingdom
  • Birmingham, United Kingdom, B4 6NH
    • Birmingham Children's Hospital
  • Bristol, United Kingdom, BS2 8BJ
    • Bristol Royal Hospital for Children
  • Glasgow, United Kingdom, G51 4TF
    • Royal Hospital for Children - Glasgow
  • London, United Kingdom, WC1N 3JH
    • Great Ormond Street Hospital for Children
  • London, United Kingdom, NW1 2PG
    • University College London Hospital
  • London, United Kingdom, W2 1NY
    • St. Mary's Hospital, Paddington
  • Manchester, United Kingdom, M13 9WL
    • Royal Manchester Children's Hospital
  • Sheffield, United Kingdom, S10 2TH
    • Sheffield Children's NHS Foundation Trust
• United States
  • Arizona
    • Gilbert, Arizona, United States, 85234
      • Md Anderson Cancer Center
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hospital
  • 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, 94303
      • Lucile Packard Children's Hospital - Stanford University
    • San Diego, California, United States, 92123
      • University of California, San Diego - Rady Children's Hospital
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado - Center for Cancer and Blood Disorders
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Medical Center
  • Florida
    • Gainesville, Florida, United States, 32611
      • University of Florida (UF) - Gainesville
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Ann and Robert H. Lurie Children's Hospital of Chicago
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine in St. Louis
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10032
      • New York Presbyterian Hospital
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern
    • Fort Worth, Texas, United States, 76104
      • Cook Children's Medical Center
  • Utah
    • Salt Lake City, Utah, United States, 81432
      • Intermountain HealthCare - Primary Children's Hospital
  • Washington
    • Seattle, Washington, United States, 98101
      • Seattle Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Undergone allogeneic cell transplantation ≥21 days prior to dosing

• Meet one of the below criteria:

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

  2. AdV viremia DNA results of ≥1,000 copies/mL, AND

     1. has absolute lymphocyte count <180/mm3, OR
     2. has received T cell depletion OR
     3. 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Posoleucel + SoC; Posoleucel + SOC; then placebo + SOC for patients who meet optional protocol-defined crossover criteria	Drug: Posoleucel; Administered as 2-4 milliliter infusion, visually identical to placebo
Placebo Comparator: Placebo + SoC; Placebo + SOC; then Posoleucel + SOC for patients who meet optional protocol-defined crossover criteria	Drug: Placebo; Administered as 2-4 milliliter infusion, visually identical to Posoleucel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with undetectable adenovirus infection	Primary Efficacy	29 days
Incidence and severity of treatment-emergent adverse events (TEAEs)	Primary Safety	34 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall disease progression or non-relapse mortality	Key Secondary Efficacy	34 weeks
Mean area under the curve (AUC) AdV viral load	Other Secondary Efficacy	29 days
Proportion of participants who achieve AdV viremia <400 copies/mL	Other Secondary Efficacy	29 days
Time to undetectable AdV viremia (less than LLOQ)	Other Secondary Efficacy	34 weeks
Incidence of AdV disease recurrence	Other Secondary Efficacy	34 weeks

Collaborators and Investigators

• Sponsor: AlloVir

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2022
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: December 17, 2021
• First Submitted That Met QC Criteria: January 4, 2022
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): February 2, 2024
• Last Update Submitted That Met QC Criteria: February 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Stem Cell Transplant; Bone Marrow Transplant; Adenovirus; Allogeneic Hematopoietic Cell Transplant; ALVR105; Posoleucel; Adenoviremia
• Additional Relevant MeSH Terms: Pathologic Processes; Virus Diseases; Disease Attributes; DNA Virus Infections; Infections; Communicable Diseases; Adenoviridae Infections
• Other Study ID Numbers: P-105-303

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