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).

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.

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.