On June 22, 2026, China’s National Medical Products Administration approved satricabtagene autoleucel (brand name Kailimei; satri-cel) for Claudin18.2-positive advanced gastric cancer. It is the world’s first, and currently only, CAR-T product approved for a solid tumor —launched in China, taking CAR-T therapy beyond blood cancers for the first time.
Photo: Jiahui International Hospital official news (jicc.jiahui.com/news/222). T-cell collection of the first overseas patient to receive solid-tumor CAR-T in China.
How it works: a ‘homing head’ that finds gastric cancer
CAR-T stands for chimeric antigen receptor T-cell therapy. Think of it this way: a squad of the patient’s own immune soldiers — T cells — is withdrawn from the body, fitted in the lab with a precision ‘homing head’ that recognizes the tumor, expanded in number, and sent back. Unlike ordinary drugs, these cells are not quickly metabolized. They keep multiplying and can form lasting immune memory.
The homing head on satri-cel targets Claudin18.2 (CLDN18.2) , a protein abundant on the surface of gastric cancer cells but with very limited expression in healthy tissue — an ideal tumor address plate. Reviews estimate that about 60%–80% of gastric and gastroesophageal junction adenocarcinomas express Claudin18.2.
For most of the past decade, every approved CAR-T product treated blood cancers such as leukemia and lymphoma. Solid tumors account for over 90% of human tumors but pose three barriers: dense tissue that cells struggle to enter, a tumor environment that exhausts immune cells, and cancer cells that may shed the target and escape. Along with a humanized Claudin18.2 antibody, satri-cel uses an innovative lymphodepletion regimen — cyclophosphamide plus fludarabine with low-dose nab-paclitaxel added — to help CAR-T cells infiltrate the tumor.
Figure 1 | How satri-cel works: T cells are collected from the patient, fitted with a Claudin18.2-targeting homing head, and reinfused to precisely kill gastric cancer cells.
The treatment process
1 Target testing and evaluation
Pathology confirms Claudin18.2 positivity (CT041-ST-01 definition: membrane staining intensity of 2+ or greater in at least 40% of tumor cells), HER2-negativity, and a treatment history matching the approved indication.
2 T-cell collection (apheresis)
The patient’s own T cells are separated from peripheral blood and shipped under cold-chain conditions to the manufacturing center.
3 Engineering and manufacturing
A lentiviral vector installs the Claudin18.2 CAR and the cells are expanded. In the pivotal study, the median turnaround from manufacturing to release was 18 days, with a minimum of 16 days.
4 Lymphodepletion and infusion
After inpatient lymphodepleting chemotherapy, CAR-T cells are infused intravenously over 10–20 minutes at 250×10⁶ cells per dose, up to 3 doses, followed by close inpatient monitoring.
Clinical results: a confirmatory randomized trial in The Lancet
The pivotal study supporting approval was CT041-ST-01 , led by Professor Lin Shen of Peking University Cancer Hospital across 24 Chinese centers. It was published in The Lancet on June 1, 2025, and presented orally at that year’s ASCO meeting. A total of 156 patients with advanced gastric or gastroesophageal junction adenocarcinoma who had failed at least two prior lines of therapy were randomized 2:1 — 104 to satri-cel and 52 to the physician’s choice of standard treatment.
By independent review in the intention-to-treat population, median progression-free survival was 3.25 versus 1.77 months , cutting the risk of progression or death by 63% (HR 0.37, P<0.0001). The objective response rate was 22% versus 4% , the disease control rate 63% versus 25% , and median overall survival 7.92 versus 5.49 months . In patients who actually received treatment, median progression-free survival was 4.37 versus 1.84 months.
Longer-term data are equally notable: 20 patients in the standard-treatment arm crossed over to satri-cel after progression and reached a median overall survival of 9.20 months. Three patients with peritoneal spread achieved long-term control of peritoneal lesions, with follow-up up to 48 months; one treated after first-line therapy saw peritoneal lesions disappear completely and underwent successful conversion surgery. ASCO 2026 also reported durable benefit beyond 4.5 years of follow-up.
About the ‘81% disease control rate’ figure That number cannot be traced to an authoritative source and should not be used. The confirmatory RCT disease control rate was 63%; ‘81.2%’ was actually the 6-month overall survival rate in the gastric-cancer subgroup of an early Phase I study, not a disease control rate.
Safety and who may be eligible
Cytokine release syndrome (CRS), the most closely watched side effect, occurred in 95% of patients, but 90.9% of cases were grade 1–2 , only 4.5% were grade 3, and there were no grade 4–5 cases. Notably, no immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in either arm — an advantage over most blood-cancer CAR-T products. Grade 3 or higher blood toxicities linked to lymphodepletion were mainly decreases in lymphocytes, white cells, and neutrophils. The study recorded one treatment-related death (disseminated intravascular coagulation).
The approved population is patients with Claudin18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma who have failed at least two prior lines of therapy. HER2-positive patients should follow trastuzumab-based regimens; the therapy is not suitable for Claudin18.2-negative, squamous, neuroendocrine, or gastrointestinal stromal tumors.
The first overseas patient: from New Zealand to Shanghai
On July 6, 2026, a 59-year-old New Zealand patient completed T-cell collection at Jiahui International Cancer Center in Shanghai, becoming the world’s first overseas patient to travel to China for solid-tumor CAR-T therapy . His disease had progressed after chemotherapy combined with immunotherapy. He had received treatment proposals from hospitals in Saudi Arabia and the United States but chose China as, in his words, the most accessible option at the time. On day 10 after infusion, his malignant ascites had visibly subsided, and he was discharged on August 16.
According to the developer, the product’s manufacturing success rate is over 98%, and 64 hospitals have completed filing . The launch price is RMB 990,000 per course, below the price of blood-cancer CAR-T products in China; registrations in Singapore, Hong Kong, and Saudi Arabia are underway. The therapy has only just launched, so qualified centers and access remain limited, and suitability must be assessed by a qualified hospital and specialist team.
Satri-cel versus conventional later-line treatment for advanced gastric cancer
Conditions It Can Treat
• Claudin18.2-positive advanced gastric cancer (approved)• Claudin18.2-positive advanced gastroesophageal junction adenocarcinoma (approved)
• Pancreatic cancer (Phase Ib exploration)
• Biliary tract cancer / cholangiocarcinoma (clinical exploration)
• Post-surgery adjuvant / consolidation therapy for gastric cancer (under study)
• Other Claudin18.2-positive solid tumors (under study)Want to know if this technology is right for you? Joyful Medical can help organize your medical records, connect you with the Chinese hospitals and specialist teams using this technology, and assess a treatment plan in China. After you submit your case, our coordinator will contact you. Free Case Evaluation