Summary

Location
at San Diego, California and other locations
Dates
study start
estimated completion

Description

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).

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

Details

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.

Keywords

Adenovirus Infection, Allogeneic Hematopoietic Cell Transplant, Adenoviremia, Adenovirus, Stem Cell Transplant, Posoleucel, ALVR105, Bone Marrow Transplant, Infections, Communicable Diseases, Adenoviridae Infections

Eligibility

You can join if…

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University of California, San Diego - Rady Children's Hospital accepting new patients
    San Diego California 92123 United States
  • University of California, Los Angeles (UCLA) accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AlloVir
ID
NCT05179057
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 80 study participants
Last Updated