Lyell shares positive data for dual-targeting CAR-T in large B-cell lymphoma

Lyell Immunopharma announced positive new clinical data demonstrating high rates of durable complete responses from the phase 1/2 trial of its dual-targeting CD19/CD20 CAR-T cell candidate, including data from patients with large B-cell lymphoma (LBCL) treated in the third- or later-line setting.

In patients treated in the 3L+ setting (N=25), Lyell’s LYL314 continued to demonstrate robust clinical responses, with an 88% overall response rate and a 72% complete response rate. Of the 3L+ patients who achieved a complete response, 71% remained in complete response at ≥ 6 months.

“Based on these robust data, and our recent End-of-Phase 1 meeting with the FDA, we have initiated PiNACLE, a single-arm pivotal trial of LYL314 in patients with large B-cell lymphoma in the third- or later-line setting and remain on track to initiate a pivotal trial to evaluate LYL314 in the second-line setting by the beginning of 2026,” said Lynn Seely, MD, Lyell’s President and CEO.

LYL314 is designed with an ‘OR’ logic gate to target B-cells that express either CD19, CD20 or both. It is manufactured to produce a CAR-T cell product with higher proportions of naïve and central memory T-cells through a proprietary process that enriches for CD62L-expressing cells. This manufacturing process is designed to generate CAR-T cells with enhanced antitumor activity.

LYL314 has received regenerative medicine advanced therapy (RMAT) designation, as well as fast track designation from the FDA for the treatment of patients with relapsed and/or refractory aggressive B-cell lymphoma in the third- or later-line setting.