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The Chinese randomised trial in which Claudin 18.2 CAR-T cells delayed progression compared with the doctor's choice of later-line drugs in stomach cancer, the first randomised trial of CAR-T cells in a solid tumour.
CT041-ST-01 is an open-label, multicentre phase Ib/II programme of satricabtagene autoleucel (satri-cel, CT041), an autologous Claudin 18.2 CAR-T, sponsored by CARsgen. The pivotal phase 2 portion randomised patients in China with Claudin 18.2-positive (immunohistochemistry intensity at least 2+ in at least 40 percent of tumour cells) advanced gastric or gastro-oesophageal junction cancer refractory to at least two previous lines, 2 to 1, to satri-cel or treatment of physician's choice (nivolumab, paclitaxel, docetaxel, irinotecan or rivoceranib). Satri-cel was infused up to three times at 250 million cells. Patients on physician's choice could receive satri-cel after progression or intolerance. The primary endpoint was progression-free survival by independent review in the intention-to-treat population.
Between March 2022 and July 2024, 266 patients were screened and 156 randomised (104 to satri-cel and 52 to physician's choice); 88 and 48 received study treatment. Median progression-free survival was 3.25 months with satri-cel versus 1.77 months with physician's choice (hazard ratio 0.37, 95% CI 0.24 to 0.56, one-sided log-rank p less than 0.0001). The authors describe it as the first randomised controlled trial of CAR T-cell therapy in solid tumours and conclude that it supports satri-cel as a third-line option (The Lancet 2025). The abstract does not report overall survival.
Satri-cel is approved in China for Claudin 18.2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma after earlier lines on this trial (see the drug record). The registry lists the broader phase Ib/II shell as active and no longer recruiting, with an estimated 192 participants including pancreatic cohorts that are outside this phase 2 report.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
156 randomised.
95% CI 2.86 to 4.53 · 95% CI 1.61 to 2.04
Source| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Progression-free survival (independent review, intention-to-treat)primary | Satricabtagene autoleucel | 104 | 3.25 months | 0.37 (0.24 to 0.56) | <0.0001 (one-sided) | link |
| Treatment of physician's choice | 52 | 1.77 months |
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