CARsgen showcases Satri-cel breakthroughs at ASCO 2025 and in The Lancet

SHANGHAI, June 2, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that the results of the pivotal Phase II clinical trial in China (CT041-ST-01, NCT04581473) investigating satricabtagene autoleucel ("satri-cel", CT041) (a Claudin18.2-specific autologous CAR T-cell product candidate) in patients with Claudin18.2-positive, advanced gastric/gastroesophageal junction cancer refractory to at least two prior lines of treatment, have been published in The Lancet and were orally presented at the 2025 ASCO Annual Meeting. Further details have been posted on the corporate website https://www.carsgen.com.

The article in The Lancet was titled "Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) versus treatment of physician's choice for previously treated advanced gastric or gastro-oesophageal junction cancer (CT041-ST-01): a randomised, open-label, phase 2 trial". Full article available at: https://doi.org/10.1016/S0140-6736(25)00860-8.

The oral presentation at the 2025 ASCO Annual Meeting (Abstract 4003) was titled "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)".

Professor Lin Shen from Beijing Cancer Hospital, the principal investigator of this study, said, "The CT041-ST-01 trial represents the world's first randomized controlled clinical study of CAR-T cell therapy for solid tumors. In patients with heavily pretreated, advanced gastric/gastroesophageal junction cancer who have extremely limited treatment options and poor prognosis, satri-cel has demonstrated breakthrough efficacy with significant clinical benefits, including much improved progression-free survival (PFS), overall survival (OS), and tumor response rates. This brings new hope to patients with otherwise medically untreatable conditions. We are further exploring satri-cel's potential in adjuvant settings and as first-line sequential therapies, aiming to intervene earlier in the disease course, extend patients' survival, and ultimately pursue potential cures."

Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, "We are honored that the CT041-ST-01 study results were published in The Lancet—a premier, global medical journal—and presented at the 2025 ASCO Annual Meeting. The positive result of this randomized controlled trial marks a major milestone in solid tumor CAR-T therapy. These achievements are a testament to the whole research team's years of dedication, and we extend our deepest gratitude to patients and their families for their trust and participation. This year, satri-cel has been granted Breakthrough Therapy Designation and Priority Review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. We plan to submit a New Drug Application (NDA) for satri-cel to the NMPA this month and anticipate its approval as the world's first commercially available CAR-T product for solid tumors, bringing benefits to patients."

For more information, please visit https://www.carsgen.com/