Claudin18.2-specific CAR T cells (Satri-cel) versus treatment of physician's choice (TPC) for previously treated advanced gastric or gastroesophageal junction cancer (G/GEJC): Primary results from a randomized, open-label, phase II trial (CT041-ST-01).

作者：Changsong Qi, Chang Liu, Zhi Peng, Yanqiao Zhang, Wei Jia, Wensheng Qiu, Xiaotian Zhang, Hongming Pan, Zuoxing Niu, Meng Qiu, Yanru Qin, Weijia Fang, Feng Ye, Ning Li, Tianshu Liu, Yumeng Wang, Daijing Yuan, Zonghai Li, Lin Shen · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco.2025.43.16_suppl.4003 · 被引用次数：3 · 研究领域：CAR-T cell therapy research、Cancer Immunotherapy and Biomarkers、Biomedical Ethics and Regulation

4003 Background: Claudin18.2 (CLDN18.2) has emerged as a promising therapeutic target in G/GEJC. Recently reported results showed CT041/satricabtagene autoleucel (satri-cel), an autologous CLDN18.2-specific CAR T-therapy, had encouraging efficacy in previously treated patients (pts) with advanced G/GEJC. Now we report the primary results from the phase II pivotal trial (CT041-ST-01, NCT04581473). Methods: In this open-label, multicenter, randomized controlled trial (RCT) conducted in China, CLDN18.2 positive, advanced G/GEJC pts with failure to at least 2 prior lines of treatment, were randomized (2:1) to satri-cel arm or TPC arm. For satri-cel arm, satri-cel dose of 250 ×10 6 cells were infused up to 3 times. For TPC arm, one of the standard of care (SOC) drugs (apatinib, paclitaxel, docetaxel, irinotecan or nivolumab) was given per physician's decision. Those who experienced disease progression or drug intolerance in TPC arm could receive subsequent satri-cel, if eligible. The primary endpoint was PFS assessed by the Independent Review Committee (IRC). Key secondary endpoint was OS. Data cutoff date was Oct 18, 2024. Results: From Mar 29, 2022 to Aug 16, 2024, a total of 156 pts were randomized to satri-cel arm (n = 104) or TPC arm (n = 52). Twenty pts in TPC arm received subsequent satri-cel. Median number of prior systemic therapies was 2 in both arms, and 26.9% vs 19.2% had received ≥3 lines; 69.2% vs 59.6% had peritoneal metastasis; 71.2% vs 65.4% were Lauren diffuse/mi...