Core Viewpoint - Lyell Immunopharma has initiated the PiNACLE - H2H Phase 3 trial to evaluate its dual-targeting CAR T-cell therapy, rondecabtagene autoleucel (ronde-cel), against existing CD19-targeting therapies for relapsed or refractory large B-cell lymphoma [1][10] Group 1: Trial Details - The PiNACLE - H2H trial is a head-to-head randomized controlled trial comparing ronde-cel to either lisocabtagene maraleucel (liso-cel) or axicabtagene ciloleucel (axi-cel) in patients with relapsed or refractory large B-cell lymphoma [1][10] - The trial aims to enroll approximately 400 patients and will assess event-free survival as the primary endpoint [10] - Ronde-cel is designed to target B cells expressing either CD19, CD20, or both, with a focus on improving complete response rates and duration of responses compared to existing therapies [5][6] Group 2: Product Information - Ronde-cel has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA for the treatment of patients with relapsed or refractory large B-cell lymphoma [7] - The manufacturing process of ronde-cel aims to produce a higher proportion of naïve and central memory T cells, enhancing its antitumor activity [6][8] - The company is also conducting a single-arm pivotal trial (PiNACLE) for ronde-cel in the third-line or later setting, expected to enroll around 120 patients [10] Group 3: Expert Collaboration - A Steering Committee of distinguished lymphoma experts has been established to guide the trial's design and execution [2][3] - Experts involved include members from prominent institutions such as the University of Chicago and the Moffitt Cancer Center [4][10] - The collaboration aims to provide robust clinical data to support the potential benefits of ronde-cel over existing therapies [2][3]