China’s National Medical Products Administration (NMPA) has approved Carsgen Therapeutics’ satricabtagene autoleucel (satri-cel, CT-041), the first CAR T cleared globally for solid tumors. The autologous Claudin18.2-targeted therapy is indicated for patients with Claudin18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma after at least two prior lines of therapy. The approval follows a Phase 2 program in which the therapy met its primary progression-free survival endpoint, and data reported at ASCO highlighted an efficacy gap versus physician’s choice chemotherapies. Carsgen also described a preconditioning regimen combining low-dose nab-paclitaxel with lymphodepletion chemotherapy. For the category, the decision marks a regulatory milestone that could reframe expectations for CAR T in solid tumors, where prior attempts have struggled to reach approval endpoints. Companies will now watch follow-on safety, logistics, and payer uptake as a first solid-tumor CAR-T model solidifies.