一次情報の記録
決定級試験登録の変更
Lyell、2L LBCLを対象としたronde-celの第3相PiNACLE-H2H試験を開始
Lyellは、2次治療の大細胞型B細胞リンパ腫（LBCL）患者を対象に、ronde-celとaxi-celまたはliso-celを比較する初の第3相無作為化頭対頭試験（PiNACLE-H2H、約400例）で患者への投与を開始した。3次治療以降のLBCLを対象とした単群ピボタル試験PiNACLEは引き続き登録を継続中（約120例）で、2027年半ばにピボタルデータが得られ、BLA申請を支える予定である。
主要事実
出典の抜粋
EX-99.1 2 lyel-20260312x8kexx991.htm EX-99.1 Document Exhibit 99.1 Lyell Immunopharma Reports Q4 and Full Year 2025 Business and Financial Results • Patient dosing has commenced in first-of-its-kind Phase 3 head-to-head CAR T-cell 2L randomized controlled clinical trial (PiNACLE-H2H) in patients with large B-cell lymphoma, and the 3L+ pivotal trial (PiNACLE) evaluating ronde-cel is ongoing • Phase 1 trial is ongoing for LYL273, an enhanced GCC-targeted CAR T-cell candidate for metastatic colorectal cancer; seven new patients treated without dose-limiting toxicity and including dose escalation to Dose Level 3 • Smital Shah was appointed Chief Financial and Business Officer in March 2026 • Second $50 million tranche of $100 million equity private placement closed in March 2026 after achie