• Maximum tolerated dose of AdV-CTL (i.e., dose with the probability closest to the target toxicity rate at the following termination points: preinfusion, 24 hours post-infusion [optional], Day 3 or 4 [optional], and 1, 2, 4, 6, and 8 weeks post-infusion)
  

Cell Administration:

In this study, AdV-specific T cells will be thawed and intravenously injected into participants. This is a traditional, phase I dose escalation study of one infusion of AdV-specific cytotoxic T lymphocytes (AdV-CTL) given to participants at risk for AdV infection after either a matched or mismatched unrelated donor stem cell transplant OR a matched or mismatched related donor stem cell transplant. Four dose levels will be studied. The lowest level will be one dose of 5 x 10^6 cells/m2, and the highest will be one dose of 1.35 x 10^8 cells/m2. Two participants at each dose level will be enrolled (depending on toxicity), using the modified continual reassessment method (CRM). This approach was successfully used in optimizing the Epstein-Barr Virus (EBV) CTL infusion regimen. If there are no toxicities and immunological efficacy is not seen at any dose, then the doses will be further escalated after additional local and federal approval. Initially, AdV-CTL will be given at least 30 days following the transplant. If participants are diagnosed with AdV infection at their 30-day evaluation or at subsequent evaluations post-CTL, they will be eligible to receive one additional dose of CTL (at the same dose as the first CTL), provided that they meet the eligibility criteria described in the protocol.

Dose Levels and Dosing Schedule:

Dose Level and CTL Dose Given from Day 30

• Dose 1: 5 x 10^6/m2
• Dose 2: 1.5 x 10^7/m2
• Dose 3: 4.5 x 10^7/m2
• Dose 4: 1.35 x 10^8/m2

Escalation of AdV-CTL Infusions:

Initially, AdV-CTL will be given 30 days following the transplant surgery. If participants are diagnosed with AdV infection (defined as culture positive from one site) at their 30-day evaluation or subsequent evaluations, they are eligible to receive one additional dose of CTL, given no less than 2 weeks apart, at the same dose of the first CTL, providing eligibility criteria are met.

Infusion of CTL:

Premedications: Participants will receive intravenously up to 1 mg/kg (up to a maximum of 50 mg) of Benadryl and 10 mg/kg (up to a maximum of 650 mg) of Tylenol prior to the injection of the cells.

Cell Administration: AdV-specific T cells will be thawed and intravenously injected 30 days following the transplant at the specified dose schedule.