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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT05179057
Other study ID # P-105-303
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date May 11, 2022
Est. completion date January 31, 2024

Study information

Verified date February 2024
Source AlloVir
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Terminated
Enrollment 51
Est. completion date January 31, 2024
Est. primary completion date January 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

Drug:
Posoleucel
Administered as 2-4 milliliter infusion, visually identical to placebo
Placebo
Administered as 2-4 milliliter infusion, visually identical to Posoleucel

Locations

Country Name City State
Canada CHU Sainte-Justine Montreal Quebec
Canada The Hospital for Sick Children (SickKids) Toronto Ontario
Italy IRCCS Ospedale San Raffaele Milano
Italy Fondazione IRCCS San Gerardo dei Tintori Monza
Italy A.O.R.N. Santobono-Pausilipon Napoli
Italy Azienda Ospedaliera di Padova Padova
Italy Fondazione IRCCS Policlinico San Matteo Pavia
Italy Ospedale Pediatrico Bambino Gesù Roma
Italy Ospedale Regina Margherita Torino
Italy Azienda Ospedaliera Universitaria Integrata Verona-Ospedale Borgo Trento Verona
Spain Hospital Universitario Vall d'Hebron Barcelona
Spain Hospital Universitario La Paz Madrid
Spain Hospital Universitari i Politecnic La Fe Valencia
Sweden Sahlgrenska University Hospital Gothenburg
Sweden Skane University Hospital Lund Lund
Sweden Karolinska University Hospital Solna
United Kingdom Birmingham Children's Hospital Birmingham
United Kingdom Bristol Royal Hospital for Children Bristol
United Kingdom Royal Hospital for Children - Glasgow Glasgow
United Kingdom Great Ormond Street Hospital for Children London
United Kingdom St. Mary's Hospital, Paddington London
United Kingdom University College London Hospital London
United Kingdom Royal Manchester Children's Hospital Manchester
United Kingdom Sheffield Children's NHS Foundation Trust Sheffield
United States Children's Hospital Colorado - Center for Cancer and Blood Disorders Aurora Colorado
United States Dana-Farber Cancer Institute Boston Massachusetts
United States Ann and Robert H. Lurie Children's Hospital of Chicago Chicago Illinois
United States Cleveland Clinic Cleveland Ohio
United States University of Texas Southwestern Dallas Texas
United States City of Hope Duarte California
United States Duke University Medical Center Durham North Carolina
United States Cook Children's Medical Center Fort Worth Texas
United States University of Florida (UF) - Gainesville Gainesville Florida
United States MD Anderson Cancer Center Gilbert Arizona
United States Hackensack University Medical Center Hackensack New Jersey
United States University of California, Los Angeles (UCLA) Los Angeles California
United States University of Minnesota Minneapolis Minnesota
United States Memorial Sloan Kettering Cancer Center New York New York
United States New York Presbyterian Hospital New York New York
United States University of Oklahoma Oklahoma City Oklahoma
United States Lucile Packard Children's Hospital - Stanford University Palo Alto California
United States Phoenix Children's Hospital Phoenix Arizona
United States Washington University School of Medicine in St. Louis Saint Louis Missouri
United States Intermountain HealthCare - Primary Children's Hospital Salt Lake City Utah
United States University of California, San Diego - Rady Children's Hospital San Diego California
United States Seattle Children's Hospital Seattle Washington
United States Children's National Medical Center Washington District of Columbia

Sponsors (1)

Lead Sponsor Collaborator
AlloVir

Countries where clinical trial is conducted

United States,  Canada,  Italy,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of participants with undetectable adenovirus infection Primary Efficacy 29 days
Primary Incidence and severity of treatment-emergent adverse events (TEAEs) Primary Safety 34 weeks
Secondary Overall disease progression or non-relapse mortality Key Secondary Efficacy 34 weeks
Secondary Mean area under the curve (AUC) AdV viral load Other Secondary Efficacy 29 days
Secondary Proportion of participants who achieve AdV viremia <400 copies/mL Other Secondary Efficacy 29 days
Secondary Time to undetectable AdV viremia (less than LLOQ) Other Secondary Efficacy 34 weeks
Secondary Incidence of AdV disease recurrence Other Secondary Efficacy 34 weeks
See also
  Status Clinical Trial Phase
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Completed NCT00711035 - Most Closely HLA Matched Allogeneic Virus Specific Cytotoxic T-Lymphocytes (CTL) Phase 1/Phase 2
Completed NCT00880789 - Safety, Toxicity and MTD of One Intravenous IV Injection of Donor CTLs Specific for CMV and Adenovirus Phase 1
Terminated NCT05305040 - Study of Posoleucel (ALVR105,Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant Phase 2/Phase 3
Completed NCT02087306 - Study to Assess the Safety and Efficacy of Brincidofovir in Treatment of Early Versus Late Adenovirus Infection Phase 3
Active, not recruiting NCT03475212 - Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation Phase 1/Phase 2
Completed NCT00590083 - Administration of Virus-Specific Cytotoxic T-Lymphocytes Phase 1
Recruiting NCT03159364 - Antigen-specific Cytotoxic T Cells in the Treatment of Opportunistic Infections Phase 1/Phase 2
Recruiting NCT05101213 - Study Assessing the Feasibility, Safety and Efficacy of Genetically Engineered Glucocorticoid Receptor Knock Out Virus Specific CTL Lines for Viral Infections in Immunosuppressed Cancer Patients Phase 1
Completed NCT01070797 - Administration of Rapidly Generated Multivirus-specific Cytotoxic T-Lymphocytes (VIRAGE) Phase 1
Active, not recruiting NCT04693637 - Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant Phase 2/Phase 3
Withdrawn NCT02276820 - Most Closely Human Leukocyte Antigen (HLA)-Matched Adenovirus-specific T Lymphocytes (Viralym-A) Phase 1
Recruiting NCT02007356 - A Study to Assess Safety and Feasibility of Direct Infusions of Donor-derived Virus-specific T-cells in Recipients of Hematopoietic Stem Cell Transplantation With Post-transplant Viral Infections Using the Cytokine Capture System® Phase 2
Withdrawn NCT02702427 - Virus-specific ImmunoTherapy Following Allogeneic Stem Cell Transplantation Phase 1/Phase 2
Completed NCT02851576 - Clinical Grade Adenovirus Specific T Cells for Immunotherapy After Allogeneic Stem Cell Transplantation (CTL-ADV) Phase 1/Phase 2
Recruiting NCT04706923 - A Phase 2a Study of IV BCV in Subjects With Adenovirus Infection (ATHENA) Phase 2