Lyell doses first affected person in section III trial for LBCL
Lyell Immunopharma has dosed the primary affected person in its PiNACLE – H2H Section III chimeric antigen receptor (CAR) cell research for relapsed or refractory (r/r) massive B-cell lymphoma (LBCL).
The top-to-head PiNACLE – H2H research compares rondcabtagene autoleucel (ronde-cel, LYL314) with lisocabtagene maraleucel (liso-cel) or axicabtagene ciloleucel (axi-cel) in sufferers receiving second-line therapy.
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It randomly assigns sufferers with r/r LBCL to obtain round-cel at a dose of 100 x 10⁶ CAR T cells or the investigator’s alternative of liso-cel or axi-cel in accordance with their product labels. The first endpoint is event-free survival.
The aim of the research is to enroll practically 200 sufferers per arm (N=400), together with sufferers with diffuse massive B-cell lymphoma, main mediastinal B-cell lymphoma, grade 3B follicular lymphoma, or remodeled mantle cell lymphoma who haven’t beforehand obtained CAR T-cell remedy, amongst others.
Spherical cell can be being evaluated within the pivotal single-arm PiNACLE trial in third- or later-line therapy settings. This research will contain 120 sufferers at nearly 25 places and can use a dose of 100 x 10⁶ CAR T cells. The first endpoint is the general response price.
Within the third-line or later-line cohort, a greatest total response price of 93% and an entire response price of 76% have been noticed in 29 efficacy-evaluable sufferers. Median progression-free survival was 18 months as of September 5, 2025.
Within the second-line cohort, 18 efficacy-evaluable sufferers confirmed an total response price of 83% and an entire response price of 61%.
Lyell Immunopharma Chief Medical Officer David Shook stated: “Information from Lyell’s single-arm pivotal PiNACLE trial in sufferers with later-stage massive B-cell lymphoma is anticipated to be submitted to the FDA for advertising and marketing approval subsequent yr.
“We are actually happy to provoke PiNACLE – H2H, the primary of its variety Section III head-to-head randomized managed CAR T-cell trial. This technique demonstrates Lyell’s confidence in Ronde-cel’s potential to be the best-in-class CAR T-cell therapy for sufferers with relapsed or refractory illness.”
In June 2025, Lyell reported new scientific knowledge from the Section I/II scientific trial of the autologous, dual-targeting CD19/CD20 CAR T-cell candidate product, LYL314, together with knowledge from individuals with LBCL in third or later line (3L+).
