原始来源记录
决策级临床试验登记变更
Lyell 启动 ronde-cel 在 2L LBCL 中的 Phase 3 PiNACLE-H2H 试验
Lyell 已开始在首个 head-to-head Phase 3 随机试验中对患者进行 dosing，比较 ronde-cel 与 axi-cel 或 liso-cel 在 second-line large B-cell lymphoma 中的应用 (PiNACLE-H2H, ~400 patients)。 pivotal single-arm PiNACLE 试验在 3L+ LBCL 中继续招募 (~120 patients)， pivotal data 预计 mid-2027，以支持 BLA submission。
关键事实
- 申报时间
- 2026年3月12日 20:12
- 事件
- 临床试验登记变更
- 方向
- 积极
- 来源
- SEC 8-K
- 可信度
- 有来源
- CR 2L
- 61%
- 三线及以上CR率
- 76%
- 二线最佳客观缓解率
- 83%
- 三线及以上mPFS
- 18个月
- 入组 2L
- 约400
- 三线及以上最佳客观缓解率
- 93%
- 入组 3Lplus
- 约120
来源摘录
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