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

A Phase 2 Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma (ZUMA-14)

The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in combination with rituximab, as measured by assessment of response rates in adult participants with relapsed/refractory large B-cell lymphoma.

Following at least 24 months of assessments after axicabtagene ciloleucel infusion, participants will be asked to rollover to a separate long-term follow-up study (Study KT-US-982-5968). Participants will complete the remainder of the 15-year follow-up assessments in the KT-US-982-5968 study.

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.