- PiNACLE – H2H will evaluate the efficacy and safety of rondecabtagene autoleucel (ronde-cel) versus Investigator’s choice of approved CD19 CAR T-cell therapies in patients with aggressive large B-cell lymphoma receiving treatment in the second-line setting
- The pivotal single-arm trial, PiNACLE, evaluating ronde-cel in the third- or later-line setting is ongoing with BLA submission expected in 2027
- Site activation for both PiNACLE – H2H and PiNACLE are underway in the United States, Canada and Australia
SOUTH SAN FRANCISCO, Calif., Feb. 12, 2026 (GLOBE NEWSWIRE) — Lyell Immunopharma, Inc. (Nasdaq: LYEL), a clinical-stage company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, today announced that the first patient has been dosed in the PiNACLE – H2H Phase 3 trial evaluating rondecabtagene autoleucel (ronde-cel, also known as LYL314) compared to lisocabtagene maraleucel (liso-cel) or axicabtagene ciloleucel (axi-cel) for the treatment of patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) receiving treatment in the second-line (2L) setting.
“Ronde-cel is a dual-targeting CD19/CD20 CAR T-cell product candidate that has demonstrated impressive clinical data in patients with aggressive large B-cell lymphoma,” said Krish Patel, MD, Director of Lymphoma Research at Sarah Cannon Research Institute (SCRI). “One of our SCRI CAR T-cell sites is the first to enroll in this important trial designed to provide physicians the data we need to make the best treatment decisions for our patients. Furthermore, this trial represents a milestone in the field of cellular therapy, being the first trial to randomize patients between different CAR T-cell therapies.”
“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,” said David Shook, MD, Lyell’s Chief Medical Officer. “We are now pleased to have underway PiNACLE – H2H, the first-of-its-kind Phase 3 head-to-head randomized 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.”
PiNACLE – H2H is a Phase 3 head-to-head CAR T-cell randomized controlled clinical trial of ronde-cel versus Investigator’s choice of either liso-cel or axi-cel in patients with R/R LBCL receiving treatment in the 2L setting. Patients randomized to ronde-cel will be treated with a dose of 100 x 106 CAR T cells; patients in the control arm will be treated as per the product label. The primary endpoint of this superiority trial is event-free survival and the trial plans to enroll approximately 200 patients per arm (N = 400) with R/R LBCL, including diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, high grade B-cell lymphoma, Grade 3B follicular lymphoma, or transformed follicular or transformed mantle cell lymphoma who have not previously received CAR T-cell therapy. Patients may be treated with ronde-cel in either the inpatient or outpatient setting.