China’s National Medical Products Administration (NMPA) approved Carsgen Therapeutics’ satricabtagene autoleucel (satri-cel, CT-041), marking the first global approval of a CAR T therapy for solid tumors. The autologous Claudin18.2-targeted CAR T received approval for patients with Claudin18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma after at least two prior lines of therapy. Carsgen said the pivotal data showed significant efficacy benefit and an acceptable safety profile compared with physician’s choice chemotherapy, with reported median progression-free survival of 3.25 months versus 1.77 months and median overall survival of 7.92 months versus 5.49 months. The approval also introduces an associated preconditioning regimen that combines low-dose nab-paclitaxel with lymphodepletion chemotherapy. The milestone matters for the CAR T field because solid tumors have historically been a tougher regulatory and clinical hurdle for cell therapies.