Lyell Immunopharma reports ronde-cel safety data at EHA 2026
Lyell Immunopharma has presented updated safety and translational data for rondecabtagene autoleucel (ronde-cel) at the European Hematology Association Congress in Stockholm, covering 108 patients with relapsed or refractory large B-cell lymphoma across second-line and third-line-plus settings as of a May 2026 data cutoff.
The Phase 1/2 dataset reflects a high-risk population: median age 64 years, 67% with primary refractory disease, and 28% carrying an International Prognostic Index score of 3 or 4. Across all patients, the company reported no Grade 3 or higher cytokine release syndrome events. Rates of Grade 3 or higher immune effector cell-associated neurotoxicity syndrome were 8% in patients who received dexamethasone prophylaxis and 16% in those who did not. Lyell said prophylaxis did not appear to alter CAR T-cell expansion or pharmacokinetics, which it described as a meaningful practical finding for clinical management.
Translational biology
Alongside the safety update, Lyell presented single-cell RNA sequencing data examining what the company believes explains ronde-cel's reported durability. The analysis identified a population of cytotoxic effector cells co-expressing memory-associated genes, labelled cytotoxic T cells with memory potential (Tcmp). These cells were more abundant in infusion products from patients who maintained responses beyond 12 months than in those with progressive disease. The company also reported that ronde-cel Tcmp cells showed stronger memory potential than analogous cytotoxic clusters from axicabtagene ciloleucel, an approved CD19 CAR T-cell product, based on gene-expression profiling.
A further finding addresses a known failure mode in CD19-targeted therapies: antigen loss. Lyell said durable complete responses of over 12 months were observed in patients whose tumour biopsies showed low CD19 or CD20 expression at baseline, which the company attributes to ronde-cel's dual CD19/CD20 targeting architecture.
Pivotal timeline and competitive context
Ronde-cel is being evaluated in two pivotal studies. The single-arm PiNACLE trial in the third-line-plus setting is expected to report updated data in the second half of 2026, with pivotal data targeted for mid-2027 and a Biologics License Application submission planned for the second half of 2027. The randomised PiNACLE-H2H Phase 3 trial in the second-line setting compares ronde-cel directly against investigator's choice of axicabtagene ciloleucel or lisocabtagene maraleucel.
The CAR T-cell space in LBCL is already served by three approved products in the United States and Europe: axicabtagene ciloleucel (Kite/Gilead), tisagenlecleucel (Novartis), and lisocabtagene maraleucel (Bristol-Myers Squibb). A fourth, brexucabtagene autoleucel, is approved in mantle cell lymphoma. Competition is therefore established rather than nascent, and any new entrant must demonstrate a meaningful differentiation on durability, safety, or logistical feasibility. Lyell's outpatient-administration argument, grounded in its low-grade toxicity data, is one of the more commercially important claims in the release, as inpatient CAR T infusion has historically been a barrier to wider adoption. That argument will carry more weight once the pivotal readout is available and reviewable by the wider haematology community.
Lynn Seely, president and chief executive of Lyell, said the updated safety profile "supports outpatient administration" and that translational data extend understanding of ronde-cel's durable clinical responses through "next-generation dual-antigen targeting and production of CD62L-enriched CAR T-cells with enhanced memory phenotype."
Lyell said its LyFE manufacturing unit has achieved a 97% success rate across all patients dosed to date and has capacity to produce more than 1,200 CAR T-cell doses per year, a figure the company is positioning as commercially relevant ahead of a potential BLA review.