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

Key Inclusion Criteria:

• Any age at the day of screening visit.

• No known or suspected clinically significant disease from AdV, BKV, CMV, EBV, HHV-6,and/or JCV

• Within 25 days of receiving a first allogeneic HCT and have demonstrated clinicalengraftment at time of dosing

• 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-geneloci: HLA-A, -B or -DR

• Haploidentical donor

• Matched or Mismatched unrelated donor

• Use of umbilical cord blood as stem cell source

• Ex vivo graft manipulation resulting in T cell depletion

• Received anti-thymocyte globulin or alemtuzumab (Campath-1H)

Key Exclusion Criteria:

• History of AdV, BKV, CMV, EBV, HHV-6, and/or JCV end-organ disease within 6 monthsprior to randomization

• Evidence of active Grade >2 acute GVHD

• Presence of non-minor uncontrolled or progressive bacterial, viral or fungalinfections

• Known history or current (suspected) diagnosis of Grade ≥3 CRS requiring treatmentassociated with the administration of peptides, proteins, and/or antibodies

• Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalentdose >1.0 mg/kg/day) within 24 hours prior to dosing

• Relapse of primary malignancy other than minimal residual disease

Note: Other protocol defined Inclusion/Exclusion criteria may apply.