also known as LYL314)
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Lyell Announces Two Oral Presentations from the Phase 1/2 Clinical Trial of Ronde-Cel for the Treatment of Aggressive Large B-Cell Lymphoma at the 67th ASH Annual Meeting and Exposition
Globenewswire· 2025-11-03 14:00
Core Insights - Lyell Immunopharma, Inc. is advancing a pipeline of next-generation CAR T-cell therapies, specifically focusing on rondecabtagene autoleucel (ronde-cel) for aggressive large B-cell lymphoma (LBCL) [1][8] - Ronde-cel has received FDA designations as Regenerative Medicine Advanced Therapy (RMAT) and Fast Track for treating relapsed and/or refractory diffuse LBCL in later lines of therapy [1][8] Clinical Data Presentation - New clinical and translational data from the Phase 1/2 trial of ronde-cel will be presented at the 67th American Society of Hematology (ASH) Annual Meeting, highlighting high overall response and complete response rates in high-risk LBCL patients [2][3] - The ongoing PiNACLE trial continues to enroll patients with LBCL in the third- or later-line setting, and a randomized controlled trial comparing ronde-cel to an approved CD19 CAR T-cell therapy is set to begin in the second-line setting [2] Manufacturing and Technology - Ronde-cel is manufactured using a process that enriches for CD62L-positive cells, resulting in enhanced naïve and central memory CAR T cells with improved antitumor activity [4][8] - The Lyell LyFE Manufacturing Center™ has the capacity to produce over 1,200 CAR T-cell doses at full capacity, supporting both ongoing and future clinical trials [8]