China approves first CAR-T therapy for a solid tumor with CARsgen’s Satri-cel

Edited by Robert McTiernan··3 min read

China’s NMPA has approved Satri-cel (satricabtagene autoleucel) for 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 first regulatory approval of a CAR T-cell therapy for any solid tumor. The milestone for Shanghai-based CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK) provides the first regulatory validation that the CAR-T approach can be translated to epithelial cancers.

Satri-cel is an autologous CAR T-cell product administered as a single infusion following a preconditioning regimen. CARsgen developed a proprietary lymphodepletion protocol that adds low-dose nab-paclitaxel to conventional cyclophosphamide and fludarabine, with the aim of enhancing CAR T-cell infiltration into the immunosuppressive solid tumor microenvironment — one of the principal barriers that has limited cellular therapy efficacy in non-hematologic cancers. The CAR construct incorporates a humanized Claudin18.2-specific single-chain antibody fragment alongside CD28 and CD3ζ intracellular signaling domains.

The approval is supported by CT041-ST-01, a randomized, open-label Phase II trial in patients with previously treated advanced G/GEJA. Results published in The Lancet in June 2025 demonstrated statistically significant efficacy benefit for satri-cel compared to physician’s choice of therapy — which in practice included trifluridine/tipiracil (Lonsurf, Taiho Oncology/Servier), the oral nucleoside analogue combination approved in this line of therapy and the most direct real-world alternative in the ≥3rd-line setting. The trial enrolled a heavily pretreated population with limited remaining options and poor prognosis.

Claudin18.2 is expressed at negligible levels in normal tissues beyond differentiated gastric mucosal epithelial cells, but is aberrantly retained at high levels across a meaningful subset of gastric cancers and other gastrointestinal malignancies. This restricted expression pattern underpins its appeal as a therapeutic target. Antigen heterogeneity within tumors remains a recognized challenge for Claudin18.2-directed therapies — the same biology that has driven interest in combination strategies across the broader GI oncology field — and CARsgen’s modified preconditioning regimen was designed in part to address this by improving CAR T-cell persistence and tumor penetration.

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The competitive landscape for Claudin18.2-positive gastric cancer is expanding across multiple modalities and lines of therapy. Astellas’s ASP2138, a Claudin18.2-targeting bispecific antibody, has demonstrated proof-of-concept in G/GEJA and is advancing toward Phase III in the first-line setting — a distinct patient population, although both therapies target Claudin18.2-positive disease. Zolbetuximab (Vyloy, Astellas) is already approved in the first-line setting for Claudin18.2-positive HER2-negative gastric cancer in combination with chemotherapy, though it does not compete directly in the ≥3rd-line niche that satri-cel now occupies.

CAR T-cell therapy has to date been confined to hematologic malignancies — B-cell lymphomas, multiple myeloma, and acute leukemias — where the accessible, antigen-uniform tumor environment is more amenable to adoptive cell transfer. Satri-cel’s approval, supported by a randomized controlled dataset, provides the first clinical validation that CAR T-cell therapy can achieve regulatory-grade efficacy in a solid tumor. Oricell’s GPC3-targeting CAR-T for hepatocellular carcinoma represents the only other NMPA-cleared CAR T confirmatory trial in a solid tumor context, underscoring how early this field remains.

Satri-cel’s development strategy under Carsgen extends beyond China. The therapy received US FDA Orphan Drug Designation in 2020 and Regenerative Medicine Advanced Therapy (RMAT) designation in 2022 for the treatment of Claudin18.2-positive advanced gastric and gastroesophageal junction cancers. CARsgen is also conducting the North America-based ELIMYN18.2 (CT041-ST-02) Phase Ib/II study in patients with Claudin18.2-positive gastric and pancreatic cancers, positioning the program for potential future regulatory filings in Western markets. CARsgen has also indicated plans to explore satri-cel in earlier lines of gastric cancer therapy, perioperative settings, and in Claudin18.2-positive pancreatic and biliary tract cancers, where the same target expression rationale applies.

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