In this study, the patients' own immune cells were engineered in the laboratory to recognise the protein claudin 18.2 on cancer cells in advanced stomach cancer, and then given back to the patient. Compared with the usual drugs, this treatment delayed the disease getting worse, but side effects such as fever caused by cytokine release and severe drops in blood cells were very common.
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.
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.
Satricabtagene autoleucel (CT041), autologous T cells with a CLDN18.2-specific CAR: up to three infusions, each of 250 × 106 cells, after collection of peripheral blood mononuclear cells (apheresis). The drugs and doses of the lymphocyte-depleting (lymphodepletion) regimen and bridging therapy are not given in the abstract or the ClinicalTrials.gov registration NCT04581473, and the full text of the Lancet paper was not available to us; for this reason these doses are not given here (104 patients; 88 received the study drug).
One of the standard drugs nivolumab, paclitaxel, docetaxel, irinotecan or rivoceranib (apatinib) at the physician's decision; on progression or intolerance, subsequent satri-cel was possible if eligible. The dose and schedule of each drug are not given in the abstract or the trial registration, and the full text was not available to us (52 patients; 48 received the drug).
Source of the regimen details: Abstract of the paper (Lancet 2025) and ClinicalTrials.gov NCT04581473; the full text and protocol of the paper were not openly available to us, so the doses of the lymphodepletion regimen and the control-group drugs could not be verified
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Patients with advanced CLDN18.2-positive adenocarcinoma of the stomach or gastro-oesophageal junction (immunohistochemical intensity 2+ or higher in 40% or more of tumour cells) refractory to at least two previous lines of therapy. Other inclusion criteria (ClinicalTrials.gov, phase 2 stage): age 18 to 75 years, HER2-negative, measurable disease per RECIST 1.1, ECOG 0 or 1 and life expectancy over 12 weeks; brain metastases, high risk of bleeding or perforation, need for anticoagulation or continuous antiplatelet therapy, active autoimmune disease and previous genetically modified cell therapy (CAR-T or TCR-T) were exclusion criteria.
Primary endpoint: progression-free survival by independent review committee assessment in the intention-to-treat population.
Grade 3 or higher treatment-emergent adverse events occurred in 87 (99%) of 88 patients in the satri-cel group and 30 (63%) of 48 patients in the treatment of physician's choice group. The most common grade 3 or higher treatment-related adverse events in the satri-cel group: decreased lymphocyte count (98%), decreased white blood cell count (77%) and decreased neutrophil count (66%). Cytokine release syndrome occurred in 95%.
The first randomised CAR-T trial in solid tumours; on this basis, satri-cel was approved in China for CLDN18.2-positive, HER2-negative cancer of the stomach or gastro-oesophageal junction, and it is the first CAR-T approved for a solid tumour (Cancer Discov 2026).
Open-label design; China only; moderate absolute benefit in progression-free survival; 15% of patients in the satri-cel group did not receive the treatment; haematological adverse events almost universal.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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