Lyell Immunopharma Initiates Pinacle - H2H, Phase 3 Head-To-Head CAR T-Cell Therapy Randomized Controlled Trial; Forms Steering Committee Of Preeminent Lymphoma Experts

• PiNACLE - H2H will evaluate rondecabtagene autoleucel (ronde-cel) versus investigator's choice of approved CD19 CAR T-cell therapies in patients with aggressive large B-cell lymphoma receiving treatment in the second line (2L) setting
• Ronde-cel is Lyell's next-generation, dual-targeting CD19/CD20 CAR T-cell therapy designed to deliver improved complete response rates and longer duration of responses over currently approved CD19 CAR T-cell therapies
• Steering Committee of distinguished lymphoma experts established to advise on the design and conduct of this first-of-its-kind CAR T-cell clinical trial

SOUTH SAN FRANCISCO, Calif., Sept. 03, 2025 (GLOBE NEWSWIRE) -- Lyell Immunopharma, Inc. (NASDAQ:LYEL), a late-stage clinical company advancing next-generation CAR T-cell therapies for patients with cancer, today 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 (ronde-cel, also known as LYL314) compared to lisocabtagene maraleucel (liso-cel) or axicabtagene ciloleucel (axi-cel) for the treatment of patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) receiving treatment in the 2L setting. Ronde-cel is an autologous dual-targeting CD19/CD20 chimeric antigen receptor (CAR) T-cell product candidate with Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) for development in patients with R/R LBCL. Ronde-cel targets B cells that express either CD19, CD20, or both, and is manufactured to produce a product with higher proportions of naïve and central memory T cells – features that are designed to deliver improved complete response rates and durability for patients.