World First: The Lancet Publishes Randomized Trial of Claudin18.2 CAR-T (satri-cel) in Gastric Cancer, Led by Peking University Cancer Hospital

Background

Advanced gastric or gastro-oesophageal junction (GEJ) cancer that has progressed after at least two lines of prior therapy has limited treatment options and poor prognosis. Claudin-18 isoform 2 (CLDN18.2) is a tight-junction protein that is frequently expressed on the surface of gastric cancer cells while showing limited expression in normal tissues, making it a target for therapy.

Researchers from Peking University Cancer Hospital conducted the CT041-ST-01 trial, a multicentre, randomised, open-label, phase 2 study of satricabtagene autoleucel (satri-cel, also known as CT041), an autologous CLDN18.2-specific CAR-T cell therapy. Results from this trial, led by Changsong Qi with contributions from Lin Shen's team, were published in The Lancet in 2025 (online May 31, print June 7-13). This was reported across sources as the first randomised controlled trial of CAR-T cell therapy to demonstrate superiority in a solid tumour.

What was achieved

The trial enrolled 156 patients aged 18-75 with pathologically confirmed CLDN18.2-positive (immunohistochemistry 2+ or 3+ in at least 40% of tumour cells), HER2-negative advanced gastric or GEJ adenocarcinoma who had progressed after at least two prior lines of systemic therapy. Patients were randomised 2:1 to receive satri-cel or treatment of physician's choice (including options such as chemotherapy or targeted agents).

In the intention-to-treat population, median progression-free survival by independent review was 3.25 months (95% CI 2.86-4.53) with satri-cel versus 1.77 months (95% CI 1.61-2.04) with treatment of physician's choice (hazard ratio 0.37, 95% CI 0.24-0.56; one-sided log-rank p<0.0001). Cytokine release syndrome occurred in 95% of patients in the satri-cel group and was described as manageable, with no reported immune effector cell-associated neurotoxicity syndrome in primary reports. Objective response rate and disease control rate were also higher with satri-cel.

Sources describe this as the first randomised controlled trial of CAR-T therapy in solid tumours globally to meet its primary endpoint of superior progression-free survival. The data from CT041-ST-01 supported the 2026 NMPA approval of satri-cel as the first CAR-T therapy approved for solid tumours.

How it works

CAR-T cell therapy is a personalised immunotherapy approach. A patient's own T cells are collected from the blood through apheresis. In a specialised manufacturing facility, these T cells are genetically modified using a viral vector to insert DNA that codes for a chimeric antigen receptor (CAR). The CAR protein on the cell surface includes an antibody fragment designed to bind specifically to CLDN18.2 on cancer cells, along with signalling domains that activate the T cell upon binding.

The modified CAR-T cells are expanded to large numbers in the laboratory and then infused back into the patient after preparatory lymphodepleting chemotherapy. Once inside the body, the CAR-T cells recognise and bind to CLDN18.2-expressing tumour cells, triggering their destruction through immune mechanisms. Patient selection requires tumour testing by immunohistochemistry to confirm adequate CLDN18.2 membrane expression. The approach aims to harness and redirect the patient's immune system against the cancer in a targeted manner.

What it means for international patients

The publication and subsequent approval mark reported progress in cellular therapy options for certain advanced gastric and GEJ cancers within China. Peking University Cancer Hospital maintains VIP wards, including dedicated services for digestive system tumours, that provide specialised care environments. Sources indicate these VIP services have been accessed by international patients, sometimes with bilingual support or coordinators.

International patients interested in satri-cel or related care must confirm current availability, exact eligibility (including CLDN18.2 testing requirements, performance status, and prior treatment history), and any language or support services directly with the hospital. Individual suitability, testing, manufacturing logistics, and access cannot be assumed and require direct verification with the treating team at Peking University Cancer Hospital.

About the hospital

Peking University Cancer Hospital, also referred to as Beijing Cancer Hospital, is located in Beijing's Haidian District. It is a Grade 3A tertiary specialised cancer hospital affiliated with Peking University, integrating clinical care, education, research, and cancer prevention. The hospital includes the Beijing Institute for Cancer Research and serves as a leading centre for oncology in China.

It maintains particular strength in gastrointestinal cancers, including gastric cancer, and participates in a large number of clinical trials. The facility operates multiple departments focused on medical oncology, surgical oncology, and early drug development, with dedicated VIP wards for patients requiring specialised services. Its official site details ongoing research output in high-impact journals, including the work on CLDN18.2 CAR-T.