Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma

Open to people ages 18 years and up

• Histologically confirmed large B-cell lymphoma
• Chemotherapy-refractory disease, defined as one or more of the following:
• No response to first-line therapy (primary refractory disease)
• No response to second or greater lines of therapy OR
• Refractory after autologous stem cell transplant (ASCT)
• At least 1 measureable lesion according to the Lugano Classification (Cheson 2014).
• Individuals must have received adequate prior therapy, including at a minimum:
• Anti-CD20 monoclonal antibody
• An anthracycline-containing chemotherapy regimen
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate renal, hepatic, pulmonary, and cardiac function

• Known CD19 negative or CD20 negative tumor
• History of Richter's transformation of Chronic Lymphocytic Leukemia (CLL)
• Prior CAR therapy or other genetically modified T-cell therapy
• Prior organ transplantation including prior allogeneic stem cell transplant (SCT)
• Prior CD19 targeted therapy
• Clinically significant infection or cardiopulmonary disease
• Presence of any in-dwelling lines or drains (dedicated central venous access catheters allowed)
• History or presence of central nervous system (CNS) lymphoma or nonmalignant CNS disorder or cerebrospinal fluid (CSF) malignant cells or brain metastases
• History of autoimmune disease
• History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the last 6 months

Note: Other protocol defined Inclusion/Exclusion criteria may apply.