Lyell Immunopharma Inc. has announced the initiation of patient dosing in the Phase 3 PiNACLE - H2H clinical trial. This study is evaluating rondecabtagene autoleucel (ronde-cel, also known as LYL314), a dual-targeting CD19/CD20 CAR T-cell therapy, compared to investigator’s choice of approved CD19 CAR T-cell therapies—specifically lisocabtagene maraleucel (liso-cel) or axicabtagene ciloleucel (axi-cel)—in patients with relapsed or refractory large B-cell lymphoma receiving treatment in the second-line setting. The trial is currently underway with site activation in the United States, Canada, and Australia. Results from this study have not yet been presented. Separately, Lyell’s pivotal single-arm PiNACLE trial of ronde-cel in the third- or later-line setting is ongoing, with a biologics license application submission to the FDA expected in 2027.

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