Open Label Study of IV Brincidofovir in Adult Transplant Recipients With Adenovirus Viremia

Inclusion Criteria:

- Be ≥ 18-years-old (or per local law or regulations on legal age of consent).

- Have received an allogeneic hematopoietic cell transplant (HCT) within the previous
100 days.

- Have plasma AdV DNA viremia ≥ 1,000 copies/mL (via quantitative polymerase chain
reaction assay; local results must be confirmed by the designated central virology
laboratory).

Exclusion Criteria:

- Diarrhea meeting the US National Institutes of Health (NIH)/National Cancer Institute
(NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater

- Acute graft versus host disease (GVHD)

1. NIH Stage 2 or higher acute GVHD of the gut (i.e., diarrhea > 1,000 mL/day, or
severe abdominal pain with or without ileus) or liver (i.e., bilirubin > 3 mg/dL
: > 51 μmol/L) within 7 days prior to Day 1

2. Any NIH Stage 3 or Stage 4 acute GVHD within 7 days prior to Day 1

- Concurrent human immunodeficiency virus or active hepatitis B or C infection

- An estimated creatinine clearance of < 30 mL/min, and/or use of renal replacement
therapy within 7 days prior to Day 1.

- Poor clinical prognosis, including active malignancy, irreversible organ failure, use
of vasopressors, requirement for mechanical ventilation, resting oxygen saturation <
88%, or Pulmonary Arterial oxygen (PaO2) ≤ 55 mm Hg without supplemental oxygen at any
time within 7 days prior to Day 1.

- Receiving or anticipated to start systemic cyclosporine immunosuppressant treatment
during study participation.

- Received treatment with CDV within 14 days prior to Day 1.

- Previous receipt of cell-based anti-AdV therapy within 6 weeks prior to Day 1 or prior
receipt of an anti-AdV vaccine at any time.

- Consumed food products containing sesame seeds, sesame oil, or dietary supplements
containing sesamin within 3 days prior to Day 1.

- Received any investigational drug within 28 days prior to Day 1 or currently
participating in another interventional study.

- Pregnant or breastfeeding.