Lyell Immunopharma has dosed the first patient in its PiNACLE – H2H Phase III chimeric antigen receptor (CAR)-cell trial for relapsed or refractory (r/r) large B-cell lymphoma (LBCL).
The head-to-head PiNACLE – H2H study compares rondecabtagene autoleucel (ronde-cel, LYL314) with lisocabtagene maraleucel (liso-cel) or axicabtagene ciloleucel (axi-cel) in patients receiving second-line treatment.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
It randomly assigns patients with r/r LBCL who will receive either ronde-cel at a dose of 100 x 10⁶ CAR T cells or the investigator’s choice of liso-cel or axi-cel as per their product labels. The primary endpoint is event-free survival.
The trial aims to enrol nearly 200 patients per arm (N = 400), including those with diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, Grade 3B follicular lymphoma, or transformed mantle cell lymphoma who have not previously received CAR T-cell therapy, among others.
Ronde-cel is also being evaluated in the pivotal single-arm PiNACLE trial in third- or later-line treatment settings. This study will enrol 120 patients at nearly 25 sites and uses a dose of 100 x 10⁶ CAR T cells. The primary endpoint is the overall response rate.
In the third- or later-line cohort, a best overall response rate of 93% and a complete response rate of 76% were observed among 29 efficacy-evaluable patients. Median progression-free survival was 18 months as of 5 September 2025.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataIn the second-line cohort, 18 efficacy-evaluable patients demonstrated an 83% overall response rate and a 61% complete response rate.
Lyell Immunopharma chief medical officer David Shook said: “Data from Lyell’s single-arm pivotal PiNACLE trial in patients with later-stage large B-cell lymphoma are expected to be submitted for marketing approval to the FDA next year.
“We are now pleased to have underway PiNACLE – H2H, the first-of-its-kind Phase III head-to-head randomised controlled CAR T-cell trial. This strategy demonstrates Lyell’s confidence in ronde-cel’s potential to be the best-in-class CAR T-cell treatment for patients with relapsed or refractory disease.”
In June 2025, Lyell reported new clinical data from the Phase I/II clinical trial of autologous dual-targeting CD19/CD20 CAR T-cell product candidate, LYL314, along with data from those with LBCL in the third or later line (3L+) setting.
