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

Key Inclusion Criteria:

   - 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

Key Exclusion Criteria:

   - 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.