China’s NMPA Approves First CAR T-Cell Therapy for CLDN18.-2+, HER2– Advanced Gastric/GEJ Adenocarcinoma

China’s National Medical Products Administration (NMPA) has approved satricabtagene autoleucel (satri-cel) for the treatment of patients with Claudin18.2 (CLDN18.2)-positive, HER2-negative advanced gastric/ gastroesophageal junction (GEJ) adenocarcinoma who have progressed on at least 2 prior lines of therapy, marking the world’s first CAR T-cell therapy approved for the treatment of solid tumors.¹

The regulatory decision was supported by data from a pivotal phase 2 trial (NCT04581473), which showed that at a median follow-up 9.07 months (95% CI, 6.21-13.01) in the satri-cel group (n = 104) and 3.45 months (95% CI, 2.89-not estimable) in the treatment of physician’s choice group (n = 52), satri-cel generated a median progression-free survival (PFS) of 3.25 months (95% CI, 2.86-4.53) compared with 1.77 months (95% CI, 1.61-2.04) for treatment of physician’s choice (HR, 0.37; 95% CI, 0.24-0.56; one-sided log-rank P < .0001).²

"For patients with advanced gastric/GEJ adenocarcinoma who have [progressed on] multiple lines of prior therapy, previous treatment options were extremely limited, and the prognosis was very poor. The approval of satri-cel provides us with a novel and effective therapeutic weapon,” Lin Shen, MD, of Peking University Cancer Hospital in China, stated in a news release.¹ “This product has brought clinically meaningful and significant benefits to such patients, with remarkable efficacy that is difficult to achieve with existing treatment modalities. More importantly, as a CAR T product, satri-cel offers patients the opportunity to break free from the constraints of frequent hospital visits for treatment, achieving a leap from 'prolonging survival' to 'improving quality of life.' As the world's first successfully marketed CAR [T-cell] therapy for solid tumors, satri-cel not only fills the gap in later-line treatment for advanced gastric cancer but also ushers in a new era of cellular therapy for solid tumors. This breakthrough lays a critical foundation for advancing frontline therapy and combination treatment strategies and is expected to reshape the treatment landscape of gastric cancer and even gastrointestinal tumors. We believe that with the promotion of clinical application, this innovative therapy will illuminate new hope for life for the vast number of gastric cancer patients."

What is satri-cel, and how was the pivotal trial designed?

Satri-cel is an autologous CAR T-cell therapy targeting CLDN18.2, with the modified CAR construct comprising a humanized CLDN18.2-specific single-chain monoclonal antibody fragment, a CD8α hinge region, a CD28 transmembrane region, a CD28 intracellular signaling domain, and a CD3ζ intracellular signaling region.

The pivotal trial was a phase 1b/2 study that enrolled patients 18 to 75 years of age; in phase 1b, patients needed to have pathologically confirmed advanced gastric/ GEJ adenocarcinoma that progressed after at least 2 prior lines of treatment, and patients with pathologically confirmed advanced pancreatic cancer who progressed on at least 1 prior line of treatment.³ In phase 2, enrollment was confined to patients with pathologically confirmed advanced gastric/GEJ adenocarcinoma who progressed on at least 2 prior lines of treatment. Confirmed CLDN18.2 positivity was required in both parts of the trial, while negative HER2 status was needed only for phase 2.

Other key inclusion criteria comprised a life expectancy of more than 12 weeks, measurable disease per RECIST 1.1 criteria, and an ECOG performance status of 0 or 1.

In phase 2, patients were randomly assigned to receive satri-cel or physician’s choice of treatment comprising paclitaxel, irinotecan, apatinib (rivoceranib; Aitan in China) or an anti–PD-1 antibody, with best supportive care. Satri-cel was administered as up to 3 infusions at doses of 250 x 10⁶ cells.²

Safety was the primary end point in phase 1b; in phase 2, PFS served as the primary end point.³ Key secondary end points in phase 2 included overall survival, objective response rate, duration of response, and disease control rate.

What safety data were reported for satri-cel?

In the phase 2 portion of the trial, grade 3 or higher treatment-emergent adverse effects (TEAEs) were reported in 99% of evaluable patients in the satri-cel group (n = 88) vs 63% of evaluable patients in the physician’s choice group (n = 48).²

In the satri-cel group, the most common grade 3 or higher treatment-related TEAEs included decreased lymphocyte count (98%), decreased white blood cell count (77%), and decreased neutrophil count (66%). Additionally, 95% of patients treated with CAR T-cell therapy experienced cytokine release syndrome.

References

1. CARsgen announces approval of satri-cel, the world's first CAR T-cell therapy product for solid tumors. News release. CARsgen. June 22, 2026. Accessed June 22, 2026.https://www.carsgen.com/en/news/20260622/
2. Qi C, Liu C, Peng Z, et al. Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) versus treatment of physician's choice for previously treated advanced gastric or gastro-oesophageal junction cancer (CT041-ST-01): a randomised, open-label, phase 2 trial. Lancet. 2025;405(10494):2049-2060. doi:10.1016/S0140-6736(25)00860-8
3. Study to evaluate the efficacy, safety and pharmacokinetics of CT041 autologous CAR T-cell injection. ClinicalTrials.gov. Updated June 5, 2025. Accessed June 22, 2026. https://clinicaltrials.gov/study/NCT04581473