Approved treatment — gastric cancer CAR-T therapy (China), Claudin18.2-positive, HER2-negative advanced gastric/GEJ cancer (third line onward)
CAR-T therapy for gastric cancer has been approved for the first time. In June 2026, China's National Medical Products Administration (NMPA) approved the CAR-T cell therapy satri-cel for Claudin18.2-positive, HER2-negative advanced gastric and gastroesophageal junction (GEJ) cancer that has progressed after at least two prior lines of treatment. It is the world's first CAR-T approved for a solid tumor, and in a randomized phase 2 trial it lowered the risk of disease progression by 63%.
What is satri-cel, the CAR-T therapy for gastric cancer?
CAR-T (chimeric antigen receptor T-cell) therapy collects a patient's own T cells, equips them with a receptor that recognizes a marker on cancer cells, and returns them to the body. Until now, every approved CAR-T product treated blood cancers such as lymphoma, leukemia and multiple myeloma. Solid tumors such as stomach or lung cancer had no approved CAR-T because suitable targets were hard to find.
Satri-cel (satricabtagene autoleucel), developed by China's CARsgen Therapeutics, targets Claudin18.2 (CLDN18.2), a protein found on many gastric cancer cells. In healthy tissue Claudin18.2 is found only in differentiated cells of the stomach lining, while it is highly expressed in gastric cancer and several other tumors, which makes it an attractive target. The general CAR-T workflow is described in our CAR-T treatment process article.
How does gastric cancer CAR-T differ from blood cancer CAR-T?
Cell collection, manufacturing and infusion follow the same flow as blood cancer CAR-T, with two differences:
- Number of infusions: most blood cancer CAR-T products are given once, while satri-cel is given as 250 million cells per infusion, up to three times.
- Conditioning: low-dose nab-paclitaxel is added to the usual lymphodepleting drugs (fludarabine and cyclophosphamide). While the cells are being made, one cycle of bridging therapy such as irinotecan keeps the disease in check.
Which gastric cancer patients are eligible?
The Chinese approval covers patients who meet all three conditions:
- Advanced gastric adenocarcinoma or GEJ adenocarcinoma
- Claudin18.2-positive and HER2-negative on tissue testing
- Disease progression after at least two prior lines of therapy
The trial enrolled patients aged 18 to 75 with good performance status (ECOG 0 or 1) and a life expectancy of more than 12 weeks. Claudin18.2 testing is also available in Japan: when the Claudin18.2 antibody zolbetuximab (Vyloy) was approved there in March 2024, its companion diagnostic test was introduced with it. In zolbetuximab's SPOTLIGHT and GLOW trials, about 38% of screened gastric cancer patients were Claudin18.2-positive. For HER2-positive gastric cancer, see our article on zanidatamab for HER2 gastric cancer.
Phase 2 results: 63% lower risk of progression, 22% response rate
The approval rests on CT041-ST-01 (NCT04581473), the first randomized trial of CAR-T therapy in solid tumors, published in The Lancet in 2025 and led by Professor Lin Shen's team at Peking University Cancer Hospital. A total of 156 patients were randomized 2:1 to satri-cel (104) or treatment of physician's choice (52): nivolumab, paclitaxel, docetaxel, rivoceranib or irinotecan.
| Measure | Satri-cel | Physician's choice |
|---|---|---|
| Median progression-free survival | 3.25 months | 1.77 months (HR 0.37) |
| Median overall survival (all randomized) | 7.92 months | 5.49 months (HR 0.69) |
| Median overall survival (patients treated) | 8.61 months | 5.49 months (HR 0.60) |
| Objective response rate (tumor shrinkage) | 22% | 4% |
| Disease control rate | 63% | 25% |
| Median duration of response | 5.52 months | 4.47 and 5.42 months (2 responders) |
Source: CT041-ST-01, The Lancet 2025 (as reported by CancerNetwork and CGTLive). Progression-free survival assessed by a blinded independent review committee. A hazard ratio below 1 favors satri-cel.
From the third line onward, options are few and benefits tend to be small. In this setting satri-cel nearly doubled the time without progression and raised the share of patients whose tumors shrank more than fivefold. The 20 patients who switched to satri-cel after progressing on physician's choice had a median overall survival of 9.20 months.
What are the side effects and how are they managed?
The most common side effect is a drop in blood counts (lymphocytes, white cells and neutrophils), an expected effect of the lymphodepleting chemotherapy given before infusion. The care team checks blood counts frequently and manages them until they recover.
Cytokine release syndrome (CRS, fever or low blood pressure caused by activated immune cells) occurred in 95.5% of treated patients; 90.9% of patients had mild grade 1–2 reactions and 4.5% had grade 3; the care team monitors fever and blood pressure closely after each infusion and treats CRS according to its grade. No neurological side effects (ICANS), a known concern with blood cancer CAR-T, were reported. Treatment-related deaths were equal in the two groups, one each.
Where is gastric cancer CAR-T therapy available?
As of November 2026, the approving country is China. The manufacturer has said it plans to expand to more countries and regions, and studies are under way in adjuvant pancreatic cancer (NCT05911217) and as sequential therapy after first-line gastric cancer treatment (NCT07179484). In Japan, the Claudin18.2 antibody zolbetuximab is already used together with chemotherapy, so knowing your Claudin18.2 status early can widen future options. For other cell therapies, see types of immune cell therapy and CAR-NK vs CAR-T.
What to check and questions for your doctor
- Has my tumor tissue been tested for Claudin18.2, and is it positive?
- Is my HER2 test negative?
- How many lines of treatment have I had, and is my condition strong enough for cell therapy?
- If I have already received zolbetuximab, should Claudin18.2 be retested?
- Are there Claudin18.2-targeted clinical trials I could join?
These questions follow the trial criteria; patients previously treated with Claudin18.2-targeted therapy were retested before enrolling. Our overview of cell therapy in Japan is on the NK cell information page.
Frequently asked questions
Is CAR-T therapy available for gastric cancer?
Yes. In June 2026 China approved satri-cel for Claudin18.2-positive, HER2-negative advanced gastric cancer that has progressed after at least two prior lines of therapy.
How is Claudin18.2 positivity tested?
Tumor tissue from surgery or endoscopy is tested with immunohistochemistry staining. In Japan, a companion diagnostic test was introduced with the 2024 approval of zolbetuximab.
How many infusions of satri-cel are given?
In the trial, patients received 250 million cells per infusion, up to three infusions, each preceded by lymphodepleting chemotherapy.
Can I receive gastric cancer CAR-T therapy in Japan?
As of November 2026, the approving country is China. In Japan, the Claudin18.2 antibody zolbetuximab was approved in 2024 and is used to treat gastric cancer.
Sources
- OncLive — China's NMPA approves first CAR T-cell therapy for CLDN18.2+, HER2– advanced gastric/GEJ adenocarcinoma (2026-06-22)
onclive.com
Checked: 2026-11-05 - CARsgen Therapeutics (PR Newswire) — Approval of satri-cel, the world's first CAR T-cell therapy product for solid tumors (2026-06-22)
prnewswire.com
Checked: 2026-11-05 - CancerNetwork — Satri-cel improves survival vs physician's choice in pretreated gastric/GEJ cancer (The Lancet 2025;405:2049-2060)
cancernetwork.com
Checked: 2026-11-05 - CGTLive — Satri-cel strides in gastric/gastroesophageal junction cancer (ASCO 2025)
cgtlive.com
Checked: 2026-11-05 - Astellas (BioSpace) — VYLOY (zolbetuximab) approved in Japan for treatment of gastric cancer (2024-03-26)
biospace.com
Checked: 2026-11-05
Written by the FTH editorial team, sources checked 2026-11-05 · Medical review: none
This article is general information based on public sources and does not replace diagnosis or treatment. Please discuss treatment decisions with your care team.
