On November 3, 2025 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation CAR T-cell therapies for patients with cancer, reported that two abstracts highlighting new clinical and translational data from the Phase 1/2 clinical trial of rondecabtagene autoleucel (ronde-cel, also known as LYL314) for the treatment of aggressive large B-cell lymphoma (LBCL) will be presented at the 67th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. Ronde-cel is a next-generation dual-targeting CD19/CD20 CAR T-cell product candidate, currently in pivotal development for the treatment of LBCL, that is designed to increase complete response rates and prolong the duration of response as compared to approved CD19‑targeted CAR T-cell therapies. The FDA has granted ronde-cel Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for the treatment of relapsed and/or refractory diffuse LBCL in the third- or later-line setting.
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"We are looking forward to presenting new clinical and translational data from the ongoing Phase 1/2 trial of ronde-cel that support the potential of targeting both CD19 and CD20 to deliver differentiated benefit for patients with aggressive large B-cell lymphoma," said David Shook, MD, Lyell’s Chief Medical Officer. "Lyell continues to enroll patients in the PiNACLE single-arm registration trial for patients with LBCL in the third- or later-line setting and is initiating a randomized controlled trial of ronde-cel versus investigator’s choice of an approved CD19 CAR T-cell therapy in the second-line setting."
Details of the presentations are below:
Rondecabtagene Autoleucel, an Autologous, Dual-Targeting CD19/CD20 CAR T-Cell Candidate Manufactured from CD62L+ Enriched T Cells, Achieves Durable Responses in Patients with Large B-Cell Lymphoma
The presentation will highlight new clinical data from the ongoing Phase 1/2 trial of ronde-cel in patients with LBCL. As of the abstract’s June 27, 2025 data cut-off date, high-risk patients with LBCL treated with ronde-cel achieved high overall response rates and complete response rates with an encouraging safety profile. New safety and efficacy data from patients receiving treatment in both the second-line and the third- or later-line settings will be presented.
Session Name: 628. Aggressive Lymphomas: Cellular Therapies: Novel Cellular Therapeutic Strategies for Aggressive Lymphomas
Session Date and Time: 12/7/2025, 4:30 PM – 6:00 PM
Presentation Time: 4:45 PM – 5:00 PM
Location: OCCC – Tangerine Ballroom F3-4
Publication Number: 668
CD62L Enrichment Achieves Robust Expansion and Memory Phenotype Post-Infusion in Patients with LBCL Treated with Rondecabtagene Autoleucel, an Autologous, Dual-Targeting CD19/CD20 CAR T-Cell Candidate
Ronde-cel is manufactured with a process that enriches for CD62L‑positive cells to generate more naïve and central memory CAR T cells with enhanced stemlike features and antitumor activity. This presentation will review translational data from the ongoing Phase 1/2 clinical trial in patients receiving treatment in the second or third- or later-line settings, highlighting that CD62L-positive cell enrichment achieves greater memory phenotype expression and in vivo cell expansion compared to published data from U.S. Food and Drug Administration-approved CAR T-cell therapies for LBCL.
Session Name: 702. CAR-T Cell Therapies: Basic and Translational: Product biology and single-cell states shaping CAR-T cell outcomes
Session Date and Time: 12/7/2025, 9:30 AM – 11:00 AM
Presentation Time: 10:00 AM – 10:15 AM
Location: OCCC – Sunburst Room (W340)
Publication Number: 501
(Press release, Lyell Immunopharma, NOV 3, 2025, View Source [SID1234659266])