Expanded Access Protocol of ATA230 (Third-Party Donor-Derived CMV-CTLs) for the Treatment of CMV Viremia or Disease

ATA230 (third-party donor-derived CMV-CTLs) are cytotoxic T lymphocytes that specifically kill cells presenting CMV protein antigens. This is an expanded access protocol designed to provide access of ATA230 to subjects with CMV viremia or disease, who are intolerant to, or failed, standard antiviral therapy and have no comparable treatment options. This study will enroll subjects regardless of the underlying susceptibility to CMV, including allogeneic hematopoietic cell transplant (alloHCT), solid organ transplant (SOT), human immunodeficiency virus (HIV), other immunocompromised states, and immune competent subjects who require therapy. Subjects must have active CMV viremia or disease for ≥ 2 weeks despite treatment with antiviral therapy or must be intolerant to antiviral therapy due to treatment-related toxicity or comorbidities such as renal insufficiency or myelosuppression. ATA230 will be administered in cycles lasting 5 weeks (35 days). During each cycle, subjects will receive intravenous (IV) ATA230 at a dose of 1×10\^6 cells/kg (with an acceptable range of 0.8-1.0×10\^6 cells/kg) on Days 1, 8, and 15, followed by observation through Day 35.