CAR-T cell therapy has already transformed the treatment landscape for blood cancers, with approved products in China and the United States achieving overall response rates exceeding 80% in many hematologic malignancies. Now, China is rapidly advancing the next frontier of CAR-T cell therapy: solid tumors.
In 2026, multiple Chinese CAR-T research programs targeting lung cancer, gastric cancer, colorectal cancer, liver cancer, pancreatic cancer, and other advanced solid tumors achieved major milestones. Several studies were presented at leading international oncology conferences and published in high-impact journals, attracting worldwide attention.
Among these breakthroughs, gastric cancer has emerged as one of the most promising fields for CAR-T therapy.
Gastric Cancer: The World’s First Solid Tumor CAR-T Therapy Nears Approval
Satricabtagene autoleucel (Satri-cel, also known as CT041) is currently the only CLDN18.2-targeted CAR-T therapy that has received Investigational New Drug (IND) clearance in both China and the United States. The therapy is expected to become the world’s first approved CAR-T treatment for solid tumors.
In June 2025, China’s Center for Drug Evaluation (CDE) accepted the New Drug Application (NDA) for Satri-cel in patients with Claudin18.2-positive advanced gastric or gastroesophageal junction adenocarcinoma (G/GEJA) who had failed at least two prior lines of therapy. This marked the first CAR-T therapy for solid tumors globally to enter the NDA stage.
If approved as expected in 2026, Satri-cel could redefine treatment options for patients with advanced gastric cancer worldwide.
Landmark Clinical Trial Presented at ASCO
At the 2025 ASCO Annual Meeting, Professor Qi Changsong from Peking University Cancer Hospital presented groundbreaking results from the world’s first randomized controlled trial evaluating a CAR-T therapy targeting the solid tumor-specific antigen Claudin18.2.
The multicenter, open-label randomized controlled study enrolled patients with advanced CLDN18.2-positive gastric or gastroesophageal junction cancer who had failed at least two previous treatment lines. The trial involved 24 research centers across China.
The results demonstrated that Satri-cel significantly improved progression-free survival, overall survival, and tumor response rates compared with standard treatment, while maintaining a manageable safety profile.
Significant Survival Improvements
The study results were highly encouraging for heavily pretreated patients with very limited treatment options.
Progression-Free Survival
Patients treated with Satri-cel achieved a median progression-free survival (PFS) of 9.07 months, compared with 3.45 months in the standard-of-care group. The risk of disease progression or death was reduced by 63%.
Overall Survival
Median overall survival (OS) reached 14.42 months in the Satri-cel group versus 11.33 months in the control group.
Among all 108 patients who received Satri-cel infusion, the median overall survival reached 9.17 months, significantly exceeding the 3.98 months observed in patients who did not receive the therapy.
Remarkable Tumor Response Rates
Independent review committee assessment showed that the confirmed objective response rate (ORR) was 22% in the Satri-cel group compared with only 4% in the physician’s choice treatment group.
Disease control rates were also significantly higher:
- Satri-cel: 63%
- Standard treatment: 25%
These findings highlight the potential of CAR-T therapy to induce meaningful tumor shrinkage even in advanced-stage gastric cancer patients who have exhausted standard treatment options.
A New Era for Solid Tumor CAR-T Therapy
Professor Shen Lin from Peking University Cancer Hospital, the principal investigator of the study, described CT041-ST-01 as the world’s first randomized controlled CAR-T clinical trial for solid tumors.
According to the research team, Satri-cel demonstrated breakthrough efficacy and substantial clinical benefit in patients with advanced gastric cancer and gastroesophageal junction cancer, including significant improvements in progression-free survival, overall survival, and tumor response rates.
Researchers are now further exploring Satri-cel in earlier treatment settings, including frontline sequential therapy and perioperative treatment strategies, with the long-term goal of extending survival and potentially achieving cure in selected patients.
China’s rapid progress in CAR-T therapy for solid tumors is opening a new chapter in cancer treatment and may soon provide new hope for patients worldwide facing advanced and treatment-resistant cancers.
