# CT041-ST-01

Source: https://onco.cc/trials/nct04581473/  
OnCo record `nct04581473` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-24
- Also known as: CT041 ST-01; satri-cel CT041-ST-01; Study to Evaluate the Efficacy, Safety and Pharmacokinetics of CT041 Autologous CAR T-cell Injection
- Tags: china
- Registry id: NCT04581473
- Phase: 1/2
- Setting: CLDN18.2-positive advanced gastric or gastro-oesophageal junction adenocarcinoma after at least two prior lines, China: satricabtagene autoleucel versus treatment of physician's choice
- Sponsor: CARsgen Therapeutics Co., Ltd.
- Enrolled: 156
- Result: Median progression-free survival 3.25 vs 1.77 months (hazard ratio 0.37) in 156 randomised patients.
- Outcomes: Progression-free survival (independent review, intention-to-treat): Satricabtagene autoleucel 3.25 months vs Treatment of physician's choice 1.77 months, HR 0.37

## Sources

- ClinicalTrials.gov NCT04581473: https://clinicaltrials.gov/study/NCT04581473
- The Lancet 2025: https://doi.org/10.1016/S0140-6736(25)00860-8

## Connected records

- cancers: [Claudin 18.2-positive gastric cancer](https://onco.cc/cancers/gastric-cldn18-2-positive/), [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/)
- technologies: [CAR-T cell therapy](https://onco.cc/technologies/car-t/)
- targets: [Claudin 18.2](https://onco.cc/targets/cldn18-2/)
- drugs: [Satricabtagene autoleucel](https://onco.cc/drugs/satricabtagene-autoleucel/)
- companies: [CARsgen Therapeutics](https://onco.cc/companies/carsgen/)
- institutions: [Peking University Cancer Hospital](https://onco.cc/institutions/pku-cancer-hospital/)
- people: [Changsong Qi](https://onco.cc/people/qi-changsong/), [Lin Shen](https://onco.cc/people/shen-lin/)
- key papers: [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](https://onco.cc/key-papers/paper-ct041-st-01-lancet-2025/)

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