June 22, 2026 —
CARsgen Therapeutics announced that China’s National Medical Products Administration has approved satricabtagene autoleucel, or satri-cel, for the treatment of patients with Claudin18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma who have failed at least two prior lines of therapy.
The approval marks a major milestone for the cell therapy field. According to CARsgen, satri-cel is the world’s first approved CAR-T cell therapy for solid tumors, expanding the reach of CAR-T beyond hematologic malignancies and into advanced gastrointestinal cancer.
Gastric cancer remains one of the world’s most burdensome malignancies, ranking among the leading causes of cancer incidence and mortality. The disease burden is especially high in Asia, with China accounting for a substantial proportion of global cases and deaths. For patients with unresectable or metastatic gastric cancer who have progressed after multiple prior therapies, treatment options remain limited and prognosis is poor.
Satri-cel is an autologous CAR-T cell therapy targeting Claudin18.2, a highly selective tumor-associated protein with limited expression in normal tissues and high expression in gastric cancer and several other malignancies. The product is genetically modified to express a CAR construct containing a humanized Claudin18.2-specific single-chain antibody fragment, CD8α hinge region, CD28 transmembrane region, CD28 intracellular signaling domain, and CD3ζ intracellular signaling region.
To address challenges associated with CAR-T therapy in solid tumors, CARsgen developed a proprietary preconditioning regimen administered before satri-cel infusion. The regimen adds low-dose nab-paclitaxel to conventional lymphodepletion with cyclophosphamide and fludarabine, with the goal of improving CAR-T infiltration and anti-tumor activity in the solid tumor microenvironment.
Clinical data supporting satri-cel’s approval include results from a confirmatory randomized controlled study published in The Lancet. According to CARsgen, the data showed significant efficacy benefit and a favorable safety profile compared with existing treatment options in heavily pretreated patients with advanced gastric or gastroesophageal junction adenocarcinoma.
The approval provides a new treatment option for patients with Claudin18.2-positive, HER2-negative advanced G/GEJ adenocarcinoma after at least two prior lines of therapy. It also establishes an important clinical precedent for CAR-T development in solid tumors, an area historically challenged by tumor heterogeneity, limited immune-cell infiltration, antigen selection, and immunosuppressive tumor microenvironments.
Beyond the approved late-line indication, CARsgen is actively evaluating satri-cel in earlier treatment settings and additional Claudin18.2-positive solid tumors. Ongoing studies include pancreatic cancer adjuvant therapy, consolidation therapy following adjuvant treatment in resected G/GEJ adenocarcinoma, and sequential therapy following first-line treatment for G/GEJ adenocarcinoma.
The approval of satri-cel represents a landmark moment for solid tumor cell therapy. If clinical use confirms its benefit in real-world practice, the therapy could help shape the next generation of CAR-T strategies for gastric cancer and other Claudin18.2-positive solid tumors.
