Genetically-Modified Immune Cells (C7R-expressing EBVSTs) for the Treatment of Relapsed or Refractory EBV-Positive Lymphoma and T/Natural Killer Lymphoproliferative Disorder, the CILESTE study

Inclusion Criteria

• INCLUSION CRITERIA AT TIME OF PROCUREMENT:
• Any patient, regardless of age or sex, with EBV-positive Hodgkin’s or non-Hodgkin’s Lymphoma, (regardless of the histological subtype) or EBV (associated)-T/NK-lymphoproliferative disease who may subsequently be eligible for the treatment component
• EBV positive tumor (can be pending)
• Weighs at least 10 kg
• Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given a copy of informed consent
• INCLUSION CRITERIA AT TIME OF INFUSION:
• Any patient regardless of age or sex, with diagnosis of either * EBV positive Hodgkin’s lymphoma * EBV positive non-Hodgkin’s Lymphoma (regardless of histologic subtype) * EBV (associated)-T/NK-lymphoproliferative disease
• AND either * In first or subsequent relapse or with persistent active disease despite therapy; OR * With active disease if immunosuppressive chemotherapy is contraindicated as determined by the study principal investigator (PI), in consultation with the primary provider as needed, e.g. patients who develop Hodgkin’s disease after solid organ transplantation or if the lymphoma is a second malignancy, e.g. a Richter's transformation of chronic lymphocytic leukemia (CLL)
• EBV positive tumor confirmed by pathology
• Patients with life expectancy >= 6 weeks
• Patients with bilirubin =< 3x upper limit of normal
• Aspartate aminotransferase (AST) =< 3x upper limit of normal
• Creatinine =< 2x upper limit of normal for age
• Hemoglobin (Hgb) >= 7.0 (may be a transfused value)
• Pulse oximetry of > 90% on room air
• Patients should have been off other investigational therapy for 4 weeks prior to entry in this study
• Patients with a Karnofsky/Lansky score of >= 50
• Informed consent explained to, understood and signed by patient/guardian. Patient/guardian given a copy of informed consent

Exclusion Criteria

• EXCLUSION CRITERIA AT TIME OF PROCUREMENT:
• Known pregnancy or actively breastfeeding (pregnancy test is not required at the time of procurement)
• EXCLUSION CRITERIA AT TIME OF INFUSION:
• Pregnant or breastfeeding
• Active and uncontrolled bacterial, viral or fungal infection
• Current use of systemic corticosteroids (prednisone equivalent >0.5 mg/kg/day)
• Bulky disease resulting in airway obstruction or risk for airway obstruction with further enlargement