China's NMPA Accepts Satri-Cel NDA for Filing
The NDA is supported primarily by data from the phase 2 CT041-ST-01 randomized controlled clinical trial.
CARsgen's new drug application (NDA) for Claudin18.2-directed chimeric antigen receptor T-cell (CAR-T) satricabtagene autoleucel (satri-cel), which is intended to treat gastric/gastroesophageal junction adenocarcinoma (G/GEJA), has been accepted for review by China's National Medical Products Administration (NMPA) for Claudin18.2-positive advanced G/GEJA in patients who have received at least 2 prior lines of unsuccessful therapy.1
“We are delighted to announce that the NDA for our self-developed Claudin18.2-targeted CAR T-cell product satri-cel has been accepted for review by China's NMPA,” Zonghai Li, MD, PhD, the founder, chairman of the board, CEO, and chief scientific officer of CARsgen, said in a statement.1 “This marks the world's first CAR T-cell therapy product for solid tumors to reach the NDA stage—a major milestone for the CAR-T field. I extend my sincere gratitude to all clinical investigators, trial coordinators, and patients involved in this program. We are hopeful for its timely approval to provide gastric cancer patients with a new treatment option.”
The NDA is supported primarily by data from the phase 2 CT041-ST-01 randomized controlled clinical trial (NCT04581473), which is being carried out in China. Notably, the company received priority review for satri-cel from the NMPA in May 2025 for the indication covered in the NDA and previously had received breakthrough therapy designation from the NMPA for it in March 2025.2,3 CARsgen has stated that it is also working to expand satri-cel's use to early-line and preioperative treatment via a phase 1b clinical trial (CT041-ST-05, NCT05911217) for it as an adjuvant treatment in pancreatic cancer and an investigator-initiated trial for it as a consolidation treatment after adjuvant therapy in G/GEJA that has been resected (CT041-CG4010, NCT06857786).1
“Gastric cancer is a malignancy with a substantial global disease burden and significant treatment challenges,” CT041-ST-01 principal investigator Lin Shen, of Beijing Cancer Hospital, added to the statement.1 “For patients with advanced gastric cancer, in particular, existing therapeutic options and their efficacy remain severely limited, resulting in extremely poor survival outcomes. Within the current treatment landscape for gastric cancer, a growing number of patients have experienced failure with immunotherapy and antiangiogenic therapies. Treatment choices and potential benefits become even more constrained in the third-line setting and beyond. Consequently, there exists a significant unmet clinical need for advanced gastric cancer patients after second-line treatment failure. The confirmatory randomized controlled clinical trial of satri-cel has clearly demonstrated that, compared with existing standard therapies, satri-cel offers significant advantages and clinical value in extending both progression-free survival (PFS) and overall survival. The trial results have garnered widespread international attention and recognition, providing a solid evidentiary foundation for satri-cel’s NDA submission. We look forward to the approval and market launch of satri-cel, which will offer a new treatment option for the broader population of gastric cancer patients.”
Data from CT041-ST-01 were recently presented by Changsong Qi, MD, PharmD, of the Peking University Cancer Hospital, in Beijing, China, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held May 30 to June 3, in Chicago, Illinois.4 Patients were randomly assigned in a 2:1 fashion to receive either satri-cel (n = 104) or a treatment of the physician’s choice (TPC; n = 52), including options such as apatinib, paclitaxel, docetaxel, irinotecan, or nivolumab. Across the intent-to-treat (ITT) population, treatment with satri-cel demonstrated a statistically significant improvement in PFS, with a median PFS of 3.25 months compared with 1.77 months in the TPC group (hazard ratio [HR], 0.366; 95% CI, 0.241–0.557; P < .0001).With regard to safety, treatment-related adverse events were reported among 35.2% of patients who were treated with satri-cel and 25% of patients treated with TPC. In the satri-cel group, 1 treatment-related death occurred and was attributed to disseminated intravascular coagulation. A single treatment-related death also occurred in the TPC group and was deemed to be caused by coagulopathy.
