Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma

A Phase 3 Randomized, Open-Label, Multicenter Study Evaluating the Efficacy of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Subjects With Relapsed/Refractory Follicular Lymphoma

The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma

Five years after the last study participant is randomized, participants who have received axicabtagene ciloleucel will transition to a separate Long-term Follow-up study (study KT-US-982-5968) to complete the remainder of the 15-year follow-up assessments.

Key Inclusion Criteria:

• Histologically-confirmed follicular lymphoma (FL) (Grade 1, 2, or 3a)
• Relapsed/refractory (R/r) disease after first-line chemoimmunotherapy and high-risk disease with relapse or progression within 24 months of the initial course of chemoimmunotherapy (ie, POD24), Or r/r disease after ≥ 2 prior systemic lines of therapy
• Clinical indication for treatment.
• At least 1 measurable lesion per the Lugano Classification {Cheson 2014}
• Adequate renal, hepatic, pulmonary, and cardiac function

Key Exclusion Criteria:

• Presence of large B cell lymphoma or transformed FL
• Small lymphocytic lymphoma
• Lymphoplasmacytic lymphoma
• Full-thickness involvement of the gastric wall by lymphoma
• FL Grade 3b
• Prior CD19-targeted therapy
• Prior CAR therapy or other genetically modified T-cell therapy
• Uncontrolled fungal, bacterial, viral, or other infection
• Active Infection with human immunodeficiency virus, hepatitis B virus or hepatitis C virus
• History or presence of a clincially significant central nervous system (CNS) disorder.
• History of autoimmune disease
• Known history or CNS lymphoma involvement
• Cardiac lymphoma involvement
• History of clinically significant cardiac disease 6 months before randomization
• Neuropathy greater than grade 2
• Females who are pregnant or breastfeeding
• Individuals of both genders who are not willing to practice birth control
• Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, G/J-tube, pleural/peritoneal/pericardial catheter, or Ommaya reservoirs). Dedicated central venous access catheters such as Port-a-Cath or Hickman catheter are permitted.

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