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

Inclusion Criteria:

   - Male or female 1 year of age or older

   - 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 >2 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.