The news at a glance
- Satri-cel is a CAR-T cell therapy: the patient's own immune cells are changed in the laboratory so that they find a protein called claudin 18.2 on stomach cancer cells and attack them [1].
- In the first randomised CAR-T study in solid cancers, the disease getting worse, or death, was about two thirds less likely with this treatment than with the usual treatment [1].
- China has approved it for advanced stomach cancer that is claudin 18.2-positive; the first CAR-T approval for a solid cancer [3].
- Its side effects are serious: fever and a strong immune reaction in almost all patients, and a big drop in blood cells [1].
- Overall survival: how long patients lived.
- Progression-free survival: how long the disease did not get worse.
- Disease-free or event-free survival: how long the disease did not come back after treatment.
- Median: the number that half of patients were above and half below; for example, "a median of 10 months" means that in half of patients the disease stayed under control for at least 10 months.
- Phase 3: a large, careful study comparing a new drug with the usual treatment; the basis of most approvals.
Talk to your doctor about what this result means for you.
What does this finding mean for patients?
This news shows that CAR-T cell therapy, which until now only worked in blood cancers, has now also worked in stomach cancer [1]. This treatment is only given in specialist centres, only for patients whose tumour has claudin 18.2 (a test on the tumour sample shows this), and it has serious side effects. For now it is only approved in China [3].
What was reported?
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CAR-T cell therapy has revolutionised the treatment of blood cancers, but its success in solid tumours has been limited [3]. Claudin 18.2 is a protein expressed in many gastric cancers and has become a promising target [1]. In the phase 1 study of satri-cel in 98 patients with gastrointestinal cancers, the overall response rate was 38.8% [2].
In the randomised phase 2 CT041-ST-01 trial in China, 156 patients with advanced claudin 18.2-positive gastric or gastro-oesophageal junction cancer refractory to at least two prior lines of treatment were randomised 2:1 to satri-cel (104 patients) or treatment of the physician's choice (52 patients). About 69% of patients in the satri-cel group had peritoneal metastases [1].
Median progression-free survival was 3.25 months in the satri-cel group and 1.77 months in the standard treatment group [1]. The investigators described it as "the world's first randomised controlled trial of CAR-T in solid tumours" [1]. On the basis of this trial, which showed improved progression-free and overall survival, China approved satri-cel [3].
This news shows that a cell therapy that until now was mostly used for blood cancers has now also worked for stomach cancer [1, 3]. This treatment is only suitable for patients whose tumour is claudin 18.2-positive on the pathology test and whose disease has got worse after several earlier treatments [1]. It has significant side effects and is given in specialist centres. If your tumour is claudin 18.2-positive, talk to your doctor about the options available (including anti-claudin 18.2 drugs and clinical trials).
Trial details and regimen (for physicians)
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- CLDN18.2 positivity in this trial: immunohistochemical staining intensity of 2+ or higher in at least 40% of tumour cells [1].
- The control group received one of nivolumab, paclitaxel, docetaxel, irinotecan or apatinib, and could receive satri-cel after progression [1].
- Grade 3 or higher adverse events occurred in 99% of the satri-cel group (mainly decreased lymphocytes, white blood cells and neutrophils) and 63% of the control group [1]. In phase 1, cytokine release syndrome was all grade 1 to 2, no neurotoxicity (ICANS) was seen and gastric mucosal injury was reported in 8.2% [2].
- Case reports from phase 1 have shown durable control of peritoneal metastases and the presence of CAR-T cells in tumour tissue months after infusion [4].
CT041-ST-01 trial regimen (investigational; not approved by the FDA or EMA)
Satricabtagene autoleucel (anti-CLDN18.2 CAR-T)
Advanced CLDN18.2-positive gastric or GEJ adenocarcinoma (IHC 2+ or higher in at least 40% of cells), refractory to at least 2 lines of treatmentCycle length: —
Advanced CLDN18.2-positive gastric or GEJ adenocarcinoma (IHC 2+ or higher in at least 40% of cells), refractory to at least 2 lines of treatment
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Satricabtagene autoleucel | 250 million (250×10⁶) cells per infusion | IV infusion | Up to 3 infusions |
Lymphodepletion regimen before infusion and intervals between infusions: dose details in the full text of the article. Of 104 patients in the satri-cel group, 88 (85%) received the treatment [1].
Evidence: CT041-ST-01 (2025)
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Limitations and next steps
- Approval: only in China, for claudin 18.2-positive, HER2-negative cancer of the stomach or of the place where the stomach joins the food pipe (gastro-oesophageal junction) [3]. It has not been approved in the US or Europe.
- Typically, the disease got worse only about a month and a half later; the study was done only in China, and patients and doctors knew which treatment was being given; some patients in the cell therapy group did not end up receiving it [1].
- Experts have stressed that more research is needed to make CAR-T work better in solid tumours [3].
The main study
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Key study
1 itemClaudin-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
References
4 referencesShow all references, 4 with a study cardClose the reference list
Numbers in the text, such as [1], refer to these sources. Sources with a “Study card” button are summarised in the site’s evidence library.
- 1Claudin-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
- 2Claudin18.2-specific CAR T cells in gastrointestinal cancers: phase 1 trial final results
- 3
- 4Long-term control of peritoneal metastases following claudin 18.2-targeted CAR T-Cell therapy in advanced gastric cancer
This page is based on reputable scientific sources and was last updated on 28 October 2026. The content of this website is for educational and informational purposes only and does not replace consultation, diagnosis or treatment by a specialist physician. Consult your treating physician about any treatment decision.
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