China approves satri-cel, the first CAR T-cell therapy anywhere for a solid tumour

China's National Medical Products Administration has approved satricabtagene autoleucel, an autologous chimeric antigen receptor T-cell therapy, for advanced gastric and gastro-oesophageal junction cancer. The approval was granted on 22 June 2026 and announced by the developer, CARsgen Therapeutics Holdings Limited, which is headquartered in Shanghai. On the company's account it is the first CAR T-cell therapy approved anywhere in the world for a solid tumour. Every CAR-T product approved before it, in the United States, Europe, China and India, treats a blood cancer.

The product is known as satri-cel and was previously designated CT041. It is a humanised CAR T-cell therapy directed at Claudin-18 isoform 2. The approved indication is CLDN18.2-positive, HER2-negative advanced gastric or gastro-oesophageal junction adenocarcinoma in patients who have failed at least two prior lines of therapy.

Claudin-18 isoform 2 is a tight-junction protein. In healthy tissue it is sequestered between gastric epithelial cells, while on gastric cancer cells it is exposed on the cell surface. That difference is what makes it addressable by a CAR T-cell while healthy tissue is spared.

Registrational evidence came from CT041-ST-01, an open-label, multicentre, randomised controlled phase 2 pivotal trial conducted in China and registered on ClinicalTrials.gov as NCT04581473. It was published in The Lancet on 7 June 2025, in volume 405, issue 10494, pages 2049 to 2060, with the digital object identifier 10.1016/S0140-6736(25)00860-8 and the PubMed identifier 40460847.

Between 22 March 2022 and 29 July 2024 the trial screened 266 patients and randomised 156 in a 2:1 ratio, 104 to satri-cel and 52 to treatment of physician's choice. Eligibility required a CLDN18.2 immunohistochemistry intensity of 2+ or greater in at least 40 per cent of tumour cells, and refractoriness to at least two previous lines of therapy. Satri-cel was infused up to three times at 250 million cells. Patients in the comparator arm received nivolumab, paclitaxel, docetaxel, irinotecan or rivoceranib at their physician's discretion.

The primary endpoint was independently reviewed progression-free survival in the intention-to-treat population. Median progression-free survival was 3.25 months with satri-cel (95% CI 2.86 to 4.53) against 1.77 months with physician's choice (95% CI 1.61 to 2.04). The hazard ratio was 0.37 (95% CI 0.24 to 0.56), with a one-sided log-rank P value of less than 0.0001.

The population was unusually advanced. Twenty-seven per cent of the satri-cel arm had already received three or more lines of treatment and 69 per cent had peritoneal metastasis. Toxicity was near-universal in the treated group: grade 3 or higher treatment-emergent adverse events occurred in 87 of 88 treated patients in the satri-cel arm, or 99 per cent, against 30 of 48 patients in the comparator arm, or 63 per cent. The commonest were decreased lymphocyte and other blood counts.

Solid tumours have resisted CAR-T for reasons that do not apply to circulating B cells. They present a physical barrier to T-cell infiltration and an immunosuppressive microenvironment, and their antigens are rarely exclusive to cancer, so on-target off-tumour toxicity has repeatedly ended programmes.

Professor Lin Shen of Peking University Cancer Hospital, Beijing, who led the clinical programme, said in the company's announcement that "the approval of satri-cel provides us with a novel and effective therapeutic weapon", noting that for patients with advanced disease who have failed multiple prior lines "previous treatment options were extremely limited". Zonghai Li is founder, chairman of the board, chief executive officer and chief scientific officer of CARsgen Therapeutics.

CARsgen has named expansion into first-line sequential therapy and post-operative adjuvant therapy in gastric cancer, a phase 1 trial of adjuvant therapy in pancreatic cancer registered as NCT05911217, and the investigator-initiated trials NCT06857786 and NCT07179484. The company says it is pursuing regulatory routes outside China, where approval would require data in non-Chinese populations.