Lyell announces initiation of Phase 3 head-to-head CAR T-cell therapy trial

Lyell Immunopharma (LYEL) announced the initiation of PiNACLE – H2H, a Phase 3 head-to-head CAR T-cell therapy randomized controlled trial and the formation of a Steering Committee of preeminent lymphoma experts. The trial is evaluating rondecabtagene autoleucel compared to lisocabtagene maraleucel or axicabtagene ciloleucel for the treatment of patients with relapsed or refractory large B-cell lymphoma receiving treatment in the 2L setting. “We believe, based on the robust emerging clinical profile demonstrated by ronde-cel in the Phase 1/2 trial, that targeting both CD19 and CD20 with full potency can deliver more complete responses and prolong the duration of remission as compared to the single antigen-targeting CD19 CAR T-cell therapies currently approved for patients with aggressive large B-cell lymphoma,” said David Shook, MD, Lyell’s Chief Medical Officer. “We are delighted to be collaborating with a distinguished group of lymphoma and cell therapy experts on the design and conduct of our ground-breaking head-to-head clinical trial and expect to begin enrolling patients by early 2026.”