ASCO 2025: First phase 2 RCT of CAR T-cell therapy in solid tumours finds promising results 

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Patients with advanced gastric or gastro-oesophageal junction (GEJ) cancer treated with CAR T-cell therapy lived on average approximately 40% longer than patients who received standard care, finds the first-ever randomised controlled trial (RCT) to look at CAR T-cell therapy in solid tumours, published in The Lancet.

The paper was presented at the American Society of Clinical Oncology [ASCO] annual meeting 2025.

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CAR (chimeric antigen receptor) T-cell therapy is a type of immunotherapy in which a patient’s T cells (a type of white blood cell) are genetically modified in a laboratory to target and kill cancer cells before being returned to the patient’s bloodstream.

CAR T-cell therapy is currently used to treat certain types of blood cancers; however, there are significant challenges in using the therapy to treat solid tumours.

This phase 2 study is the first RCT of CAR T-cell therapy in solid tumours globally.

In the trial, over 100 patients in China with advanced gastric or GEJ cancer were randomised to receive either CAR T-cell therapy or one of the standard-of-care medications.

Patients who received CAR T-cell therapy lived an average of 7.9 months after randomisation, compared to 5.5 months with standard care, and experienced 3.3 months without cancer progression versus 1.8 months in the standard care group.

Authors say CAR T-cell therapy could become a new treatment option for patients with advanced gastric or GEJ cancer, addressing a critical unmet need for these patients.


Paper: Qi, Changsong 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. The LancetAccess online here.

Source: The Lancet

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