A Study of Automated Axicabtagene Ciloleucel for R/R Large B-cell Lymphoma.

Exclusion Criteria20

• Prior history of other malignancies, with the exception of non-melanoma skin tumors, carcinoma in situ , or follicular lymphoma that have been free of recurrence for more than 3 years.
• History of Richter's transformation of CLL or PMBCL
• History of autologous or allogeneic stem cell transplant
• Received more than one line of therapy for DLBCL
• Treatment with systemic immunostimulatory agents within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to the first dose of axicabtagene ciloleucel
• Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy
• History of severe, immediate hypersensitivity reaction attributed to aminoglycosides or Tocilizumab
• Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management
• Known history of infection with human immunodeficiency virus (HIV) or Positive test result for anti-Treponema pallidum antibody (TP-Ab) or hepatitis B(HBsAg positive) or hepatitis C virus (anti-HCV positive)
• Active tuberculosis
• Presence of any indwelling line or drain
• Subjects with detectable malignant cells in the cerebrospinal fluid (CSF) or known brain metastases or with a history of cerebrospinal fluid malignant cells or brain metastases
• History or presence of non-malignant CNS disorder
• Subjects with cardiac atrial or cardiac ventricular lymphoma involvement
• History of clinically significant cardiac disease within 12 months of enrollment
• Requirement for urgent therapy within 6 weeks due to tumor mass effects, such as bowel obstruction or blood vessel compression or airway obstruction
• Patients with idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on chest CT are excluded.
• History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment
• Women of childbearing potential who are pregnant or breastfeeding
• In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation