Clinical Trials Logo

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).


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT05179057
Study type Interventional
Source AlloVir
Contact
Status Terminated
Phase Phase 3
Start date April 26, 2022
Completion date January 31, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT04722029 - Pilot Study of Haploidentical Donor Adenovirus Specific T-lymphocytes to Treat Refractory Adenovirus Infections Phase 1/Phase 2
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
Completed 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