T-Cell Therapy (EB103) in Adults With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)

Exclusion Criteria14

• Prior CD19-targeted cellular therapy
• History of Richter's transformation of chronic lymphocytic leukemia (CLL)
• History of another primary malignancy that has not been in remission for ≥ 2 years.
• History or presence of clinically relevant Central Nervous System (CNS) pathology
• CNS disease which is progressing on most recent therapy or with a parenchymal mass which is likely to cause clinical symptoms
• Subjects with active cardiac lymphoma involvement which is not responding to treatment
• History of myocardial infarction, cardiac angioplasty and stenting, unstable angina, or other clinically significant cardiac disease within 6 months of informed consent
• Active, uncontrolled systemic bacterial, fungal, or viral infection. Patients with HIV, hepatitis B, or hepatitis C are eligible provided their infection is being treated and the viral load is controlled.
• History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
• History of severe, immediate hypersensitivity reaction to any agents used in this study, including the conditioning chemotherapeutic agents
• Venous thrombosis or embolism not managed on a stable regimen of anticoagulation
• Autologous HSCT within 3 months of informed consent
• Subjects with a prior allogeneic transplant at least 6 months prior to study enrollment are eligible unless experienced graft-versus-host disease (GvHD) that requires ongoing treatment with systemic steroids or other systemic GvHD therapy, such as a calcineurin inhibitor, within 12 weeks of initial screening
• Live vaccine within 3 months prior to planned start of conditioning regimen