On November 4, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported that two abstracts featuring positive updated clinical data for rondecabtagene autoleucel (ronde-cel) have been accepted for presentation at the 68th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, taking place December 12–15, 2026, in New Orleans (ASH 2026).
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The abstracts highlight results in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) in the third- or later-line (3L+) setting in an oral presentation, and in the second-line (2L) setting in a poster presentation. Ronde-cel is a dual-targeting CD19/CD20 autologous CAR T-cell product candidate currently being evaluated in two pivotal trials: PiNACLE, a single-arm trial in the 3L+ LBCL setting intended to support an initial BLA submission for regular marketing approval, and PiNACLE-H2H, a Phase 3 randomized controlled trial comparing ronde-cel to investigator’s choice of an approved CD19-directed CAR T-cell therapy in the 2L setting. Ronde-cel has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the U.S. Food and Drug Administration (FDA) for R/R diffuse LBCL in the 3L+ setting, as well as RMAT designation for LBCL in the 2L setting.
"We believe the high complete response rates and durability of remissions observed with ronde-cel in both the second-line and third- or later-line settings, including in patients with high-risk disease, are impressive," said Jarrad Aguirre, M.D., Chief Medical Officer of Lyell. "The potential to deliver deep, lasting remissions for patients with large B-cell lymphoma is particularly compelling and reinforces our confidence in ronde-cel’s ability to meaningfully improve patient outcomes. We look forward to presenting updated results at ASH (Free ASH Whitepaper), including additional patients and longer follow-up, as we advance ronde-cel toward potential registration."
Third- or Later-Line (3L+) LBCL Oral Abstract and Clinical Highlights
Overall, 58 patients received ronde-cel as of the June 18, 2026 data cutoff date. The median age was 64 years, approximately 50% of treated patients had primary refractory disease, and 64% were refractory to their last therapy. Of 44 patients response-evaluable at Day 84, the overall response rate was 91% (40/44) and the complete response rate was 77% (34/44). Median duration of complete response was not reached. Among patients with a complete response, 92% remained in complete response at six months and 75% at 12 months. The median progression-free survival (PFS) was not reached, with estimated PFS rates of 76%, 63% and 54% at six, 12 and 24 months, respectively; median PFS follow-up was 12 months.
No Grade ≥ 3 cytokine release syndrome (CRS) was observed among all treated patients (N = 58). Grade 1 CRS occurred in 48% of patients and Grade 2 in 22% of patients. Grade ≥ 3 immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 9% of patients.
Updated results, including additional patients and longer follow-up, are expected to be presented at ASH (Free ASH Whitepaper) 2026.
Second-Line (2L) LBCL Poster Abstract and Clinical Highlights
In the fully enrolled Phase 1/2 second-line cohort, 43 patients received ronde-cel, including 86% (37/43) with primary refractory disease. Among 37 patients response-evaluable at Day 84, the overall response rate was 95% (35/37) and complete response rate was 76% (28/37). Median duration of complete response was not reached. Among patients with a complete response, 92% remained in complete response at six months and 67% at 12 months. Median PFS was not reached, with estimated PFS rates of 75% at six months and 55% at 12 months; median PFS follow-up was nine months.
No Grade ≥ 3 CRS was observed among all treated patients (N = 43). Grade 1 CRS occurred in 49% of patients and Grade 2 in 19% of patients. Grade ≥ 3 ICANS occurred in 9% of patients.
Updated results, including longer follow-up, are expected to be presented at ASH (Free ASH Whitepaper) 2026. Ronde-cel is also being evaluated in PiNACLE-H2H, an ongoing randomized Phase 3 trial in the 2L setting.
Abstract Details:
Oral Abstract 1028: Durable progression-free survival and high complete response rates with rondecabtagene autoleucel, a CD19/CD20 CAR T-cell candidate, in patients with 3L+ relapsed/refractory large B-cell lymphoma: results from the ongoing pivotal PiNACLE trial
Presenting author: Sarah M. Larson, M.D., Associate Professor in the Division of Hematology-Oncology, David Geffen School of Medicine, UCLA
Session: Monday, December 14, 2026, 4:45 CST
Poster Abstract 2402: Durable progression-free survival and high complete response rates with rondecabtagene autoleucel, a CD19/CD20 CAR T-cell candidate, in patients with predominantly primary refractory, second-line relapsed/refractory large B-cell lymphoma
Presenting author: Akil Merchant, M.D., Associate Professor and Co-Director of the Lymphoma Program, Samuel Oschin Cancer Center, Cedars-Sinai Medical Center
Session: Saturday, December 12, 2026, 5:30 CST
About Ronde-Cel
Rondecabtagene autoleucel (ronde-cel) is a next-generation, dual-targeting CD19/CD20 autologous CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response compared to approved CD19-targeted CAR T-cell therapies for R/R LBCL. Ronde-cel targets B cells expressing either CD19 or CD20 and is manufactured using a process that enriches for CD62L-positive cells designed to generate more naïve and central memory CAR T cells to improve the durability of responses by promoting in vivo persistence and the antitumor activity of CAR T cells.
Ronde-cel is being evaluated in two pivotal trials in R/R LBCL: PiNACLE is a multi-center single-arm pivotal trial in the 3L+ setting. Full pivotal data from this trial are expected in mid-2027 with BLA submission expected to follow in the second half of 2027. PiNACLE-H2H is a Phase 3 randomized controlled head-to-head CAR T-cell trial in the 2L setting. Patients with R/R LBCL following one prior line of therapy are randomized to receive ronde-cel or investigator’s choice of one of two approved CD19 CAR T-cell therapies. The FDA has granted ronde-cel Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations in the 3L+ setting and RMAT designation in the 2L setting.
(Press release, Lyell Immunopharma, NOV 4, 2026, View Source [SID1234674206])