Lyell Immunopharma Launches Phase 3 Head-to-Head CAR T-Cell Therapy Trial in Large B-Cell Lymphoma
Reuters
Nov 13, 2025
Lyell Immunopharma Launches Phase 3 Head-to-Head CAR T-Cell Therapy Trial in Large B-Cell Lymphoma
Lyell Immunopharma Inc. announced updates on its next-generation CAR T-cell therapy programs, including new developments in its clinical pipeline. The company reported that it will present new clinical and translational data from its Phase 1/2 clinical trial of ronde-cel for the treatment of aggressive large B-cell lymphoma at the upcoming ASH 67th Annual Meeting and Exposition in December. Additionally, Lyell has initiated the PiNACLE - H2H, a Phase 3 head-to-head CAR T-cell therapy clinical trial in the second-line (2L) setting for aggressive large B-cell lymphoma, with enrollment expected to begin by early 2026. The company also acquired exclusive global rights to LYL273, a novel GCC-targeted CAR T-cell product candidate, which has shown a 67% overall response rate and an 83% disease control rate with a manageable safety profile in an ongoing U.S. Phase 1 clinical trial in patients with refractory metastatic colorectal cancer. The next data update from this trial is anticipated in the first half of 2026.
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