China’s National Medical Products Administration (NMPA) has approved Carsgen Therapeutics’ Claudin18.2-targeted, HER2-negative CAR T satricabtagene autoleucel (satri-cel/CT-041) for advanced gastric or gastroesophageal junction adenocarcinoma after at least two prior lines of therapy. The approval marks the first CAR T authorization worldwide for a solid-tumor indication. In its submission, Carsgen positioned satri-cel as the first successful solid-tumor CAR T tied to Claudin18.2 as a target. The therapy was linked to reported progression-free survival and overall survival benefits versus physician’s choice chemotherapy in the company’s referenced Phase 2 results. The approval also highlights the treatment’s supporting regimen—low-dose nab-paclitaxel for preconditioning alongside lymphodepleting chemotherapy—which Carsgen said is designed to support efficacy in solid tumors where CAR T has historically faced approval hurdles.