China approves world's first CAR-T therapy for solid tumors

China’s National Medical Products Administration (NMPA) has given the green light to CARsgen Therapeutics’ satri-cel for the treatment of Claudin18.2-positive, HER2-negative advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy, marking the world’s first CAR-T therapy approved for solid tumors.

Claudin18.2 is a selective marker expressed almost exclusively in differentiated gastric mucosal epithelial cells in normal tissue but highly upregulated in gastric and other malignant tumors. Satri-cel's CAR construct uses a humanized Claudin18.2-specific single-chain antibody fragment paired with CD28 and CD3ζ intracellular signaling domains. To address the immunosuppressive tumor microenvironment — historically the core obstacle for CAR T-cell approaches in solid tumors — CARsgen developed a proprietary preconditioning regimen that adds low-dose nab-paclitaxel to conventional lymphodepletion with cyclophosphamide and fludarabine, designed to enhance CAR T-cell infiltration and anti-tumor efficacy.

Gastric cancer ranks fifth globally in incidence and mortality, with roughly 970,000 new cases and 660,000 deaths annually. Chinese patients account for approximately 47% of that burden.

Shanghai-based CARsgen said it is working to advance satri-cel's clinical application and market access in China and expand to additional countries. CARsgen is also pursuing satri-cel in earlier lines of therapy and perioperative settings for gastric cancer, including ongoing trials in pancreatic cancer adjuvant therapy and sequential first-line treatment for G/GEJA.