Primary Objectives: The primary endpoint of the study is to compare the efficacy of ronde-cel, an investigational CD19/CD20 CAR T-cell therapy, to the CD19 CAR T-cell therapies (axi-cel or liso-cel) based on EFS, defined as the time from randomization to death from any cause, disease progression, failure to achieve a response (PR or CR) by the Day 84 visit after CAR T-cell therapy administration, or start of new anti-lymphoma therapy without documented progression, whichever comes first. Response and disease progression on PET/computed tomography (CT) imaging per Lugano Criteria 2014 will be assessed by a blinded Independent Review Committee (IRC) for all patients. Key Secondary Objectives: The key secondary objectives of the study are to compare the efficacy of ronde-cel to CD19 CAR T-cell therapies (axi-cel and liso-cel) based on the ORR, CRR, PFS, and overall survival.
What is the full name of this clinical trial?
LYL314-102: A Phase 3 Randomized Controlled Trial of RONDECABTAGENE AUTOLEUCEL, An Autologous, Dual-Targeting CD19/CD20 CAR T-CELL Product Candidate, Versus Investigators Choice of CD19 CAR T-CELL Therapy in Patients With Relapsed or Refractory LARGE B-CELL Lymphoma in the Second-Line Setting PINACLE-H2H)