Lyell Immunopharma Initiates First Head-to-Head Phase 3 CAR T-Cell Trial for Aggressive Large B-Cell Lymphoma

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Lyell Immunopharma announced in February 2026 that the first patient has been dosed in the PiNACLE – H2H Phase 3 trial, marking the first head-to-head randomized controlled trial comparing different CAR T-cell therapies12

Ronde-cel is a dual-targeting CD19/CD20 CAR T-cell product candidate being tested against investigator's choice of lisocabtagene maraleucel (liso-cel) or axicabtagene ciloleucel (axi-cel) in patients with relapsed or refractory large B-cell lymphoma receiving second-line treatment12

The trial aims to enroll approximately 400 patients (200 per arm) with relapsed or refractory LBCL, including diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and other aggressive subtypes1

Ronde-cel patients will receive a dose of 100 x 106 CAR T cells, with event-free survival as the primary endpoint1

At the American Society of Hematology Annual Meeting in December 2025, Lyell reported positive clinical data showing a 93% best overall response rate and 76% complete response rate in the 3L+ cohort, with a median progression-free survival of 18 months13

Data from Lyell's single-arm pivotal PiNACLE trial in later-stage large B-cell lymphoma patients is expected to be submitted for FDA marketing approval in 202712

Sources:

1. https://www.globenewswire.com/news-release/2026/02/12/3237094/0/en/Lyell-Immunopharma-Announces-Initiation-of-Patient-Dosing-in-First-of-Its-Kind-Phase-3-Head-To-Head-CAR-T-Cell-Clinical-Trial-in-Aggressive-Large-B-Cell-Lymphoma.html

2. https://www.clinicaltrialsarena.com/news/lyell-doses-first-patient-lbcl/

3. https://www.finanznachrichten.de/nachrichten-2026-02/67687084-lyell-immunopharma-inc-lyell-immunopharma-announces-initiation-of-patient-dosing-in-first-of-its-kind-phase-3-head-to-head-car-t-cell-clinical-trial-399.htm