Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant

Key Inclusion Criteria * ≥1 year of age at the day of screening visit. * Either no evidence of viral infection or viremia, or asymptomatic, viral infection with 3 or fewer viruses of interest at time of screening * Within 15 and 42 days of receiving a first allogeneic HCT and have demonstrated clinical engraftment * Meet one or more of the following criteria at the time of randomization: * Related (sibling) donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B or -DR * Haploidentical donor * Unrelated donor with at least one mismatch at one of these HLA-gene loci: HLA-A, -B, -C, or -DR * Use of umbilical cord blood as stem cell source * Ex vivo graft manipulation resulting in T cell depletion * Lymphocyte Count \<180/mm3 and/or cluster of differentiation 4 (CD4) Count \<50/mm3 Key Exclusion Criteria: * History of AdV, BKV, CMV, EBV, HHV-6, and/or JCV end-organ disease within 6 months prior to randomization * Evidence of active Grade \>2 acute GVHD * Presence of non-minor uncontrolled or progressive bacterial, viral or fungal infections * Known history or current (suspected) diagnosis of CRS requiring treatment associated with the administration of peptides, proteins, and/or antibodies * Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose \>0.5 mg/kg/day) within 24 hours prior to dosing * Relapse of primary malignancy other than minimal residual disease Note: Other protocol defined Inclusion/Exclusion cri…