Study Assessing the Feasibility, Safety and Efficacy of Genetically Engineered Glucocorticoid Receptor Knock Out Virus Specific CTL Lines for Viral Infections in Immunosuppressed Cancer Patients

Inclusion Criteria:

• Patients > or = 18 years of age or older.

• For BKV, ADV or CMV infections: Prior myeloablative or non-myeloablative allogeneichematopoietic stem cell transplant using bone marrow, peripheral blood stem cells orsingle or double umbilical cord blood. For JC virus and COVID19 infection: no priorhematopoietic stem cell transplantation (HSCT) is required.

• For BKV infection, patients need to have polymerase chain reaction (PCR) positivefor BKV (in peripheral blood or urine) with consistent clinical symptoms.

• For ADV infection, patients need to have PCR positive for ADV in peripheral bloodAND/OR patients need to fit criteria of probable or definitive adenovirus organdisease.

• For CMV infection, patients need to have PCR positive for CMV in peripheral bloodAND/OR patients need to fit criteria of probable or definitive CMV disease.

• For JCV, patients need to have documented JC viral encephalitis or JC end-organdisease.

• For COVID-19 infection, patients need to have COVID-19 related pneumonia/acuterespiratory distress syndrome (ARDS) to be enrolled, defined as patients with apositive COVID-19 test (bronchoalveolar lavage [BAL], nasal or pharyngeal) andradiological and clinical signs of pneumonia or ARDS.

• Written informed consent from patient or designated power of attorney.

• Subjects are also are required to consent to PA17-0483 for long term follow up perthe guidelines set forth by the Food and Drug Administrations' (FDA's) BiologicResponse Modifiers Advisory Committee (BRMAC).

• Negative pregnancy blood test in female patients of childbearing potential, definedas not post-menopausal for 12 months or no previous surgical sterilization. Women ofchild bearing potential must be willing to use at least two forms of birth controlduring the study and for at least 6 months after stopping treatment. Acceptableforms of birth control include intrauterine device (IUD), hormonal methods (birthcontrol pills, injections, and implants), condoms, diaphragms, tubal ligation, orvasectomy.

Exclusion Criteria:

• Patients who have received anti-thymocyte globulin (ATG) within 14 days or havereceived donor lymphocyte infusion (DLI) or campath within 28 days of enrollment.

• Patients with other uncontrolled infections (excluding human immunodeficiency virus [HIV]/acquired immunodeficiency syndrome [AIDS]). For bacterial infections, patientsmust be receiving definitive therapy and have signs of improving infection prior toenrollment as determined by the principal investigator (PI). For fungal infections,patients must be receiving definitive systemic anti-fungal therapy and have signs ofimproving infection prior to enrollment as determined by the PI.

• Patients with active steroid refractory graft versus host disease (GVHD).

• Patients on immunosuppressive therapy other than tacrolimus, sirolimus or steroids

• Active and uncontrolled relapse of malignancy. Patients with controlled malignancyon maintenance therapy would be eligible for the study.