Satri-cel injection (CT041, Kaileimei®), the world’s first CAR-T cell therapy for solid tumors, has been approved by China’s National Medical Products Administration (NMPA) for the treatment of Claudin18.2-positive, HER2-negative advanced gastric/gastroesophageal junction (GEJ) adenocarcinoma in patients who have failed at least two prior lines of therapy.
Gastric cancer remains one of the most prevalent malignancies globally, with Easten Asian accounting for over half of all new cases and deaths worldwide. Claudin18.2 is expressed at moderate-to-high levels in over 60% of gastric cancer patients, making it a critical therapeutic target.
The approval is based on the pivotal CT041-ST-01 randomized controlled trial led by Professor Shen Lin at Peking University Cancer Hospital. In the modified intention-to-treat population, the investigator-assessed objective response rate (ORR) reached 41% for CT041 versus 4% for the control arm, with disease control rates of 81% and 27%, respectively. Median progression-free survival was significantly prolonged, reducing the risk of disease progression or death by up to 70%. Overall survival analysis using RPSFT modeling showed a 53–63% reduction in mortality risk, extending median OS by nearly six months in this heavily pretreated population.
The safety profile was manageable, with only four cases of Grade 3 cytokine release syndrome, no Grade ≥4 CRS, and no immune effector cell-associated neurotoxicity syndrome. Notably, by downgrade Claudin18.2 positivity threshold to 40%, the therapy expands the eligible patient population from approximately 38% to nearly 70% of advanced gastric cancer patients. These findings have been incorporated into the 2026 CSCO Gastric Cancer Guidelines, marking a historic milestone that establishes China as a global leader in solid tumor CAR-T therapy.
