Clinical Trials
Lyell Immunopharma launches groundbreaking Phase 3 CAR T-Cell trial for aggressive lymphoma
PiNACLE is a head-to-head study comparing its next-generation CAR T-cell therapy against established therapies liso-cel and axi-cel in patients with relapsed or refractory large B-cell lymphoma
- By IPP Bureau
| February 16, 2026
Lyell Immunopharma has announced the launch of its groundbreaking Phase 3 CAR T-Cell trial for aggressive lymphoma.
PiNACLE is a head-to-head study comparing its next-generation CAR T-cell therapy against established therapies liso-cel and axi-cel in patients with relapsed or refractory large B-cell lymphoma (LBCL) in the second-line 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, 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.”
David Shook, Lyell’s Chief Medical Officer, highlighted the company’s strategy: “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 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.”
The PiNACLE – H2H trial will enroll approximately 400 patients, with 200 receiving ronde-cel and 200 treated with either liso-cel or axi-cel per standard labeling. The trial’s primary endpoint is event-free survival.
Patients may receive ronde-cel either inpatient or outpatient, with the study including multiple aggressive lymphoma subtypes, such as diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, high-grade B-cell lymphoma, Grade 3B follicular lymphoma, and transformed follicular or mantle cell lymphoma who have not previously received CAR T-cell therapy.
