SHANGHAI, China, June 1, 2026
CARsgen Therapeutics presented promising long-term follow-up data from its investigational Claudin18.2-targeted CAR T-cell therapy, satricabtagene autoleucel (satri-cel, CT041), at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, highlighting durable clinical benefits in patients with advanced gastric and gastroesophageal junction adenocarcinoma (G/GEJA).
Long-Term Survival Benefits Demonstrated Beyond 4.5 Years
The data came from Cohort 3 of the ongoing Phase 1 investigator-initiated trial (CT041-CG4006), evaluating satri-cel as a sequential treatment following first-line therapy in patients with Claudin18.2-positive advanced gastric cancer. Five heavily pretreated patients received a single infusion of satri-cel at a dose of 2.50×10⁸ CAR T cells.
Despite poor prognostic features, including signet ring cell carcinoma, diffuse-type disease, and peritoneal metastases, the treatment produced remarkable outcomes. After a median follow-up of 54.6 months, the confirmed objective response rate (ORR) reached 100% among evaluable patients. The median duration of response had not yet been reached, demonstrating sustained antitumor activity.
Among all treated patients, the median progression-free survival (PFS) from first-line therapy was 20.9 months, significantly exceeding historical expectations for this difficult-to-treat population. Notably, two patients experienced substantial clinical improvement that enabled them to undergo surgical resection after CAR T-cell treatment and both remained alive beyond four years of follow-up.
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Strong Safety Profile Supports Earlier-Line Development
Safety findings continued to support satri-cel’s favorable risk-benefit profile. Investigators reported no Grade 3 or higher cytokine release syndrome (CRS), no cases of immune effector cell-associated neurotoxicity syndrome (ICANS), and no treatment-related deaths. Additionally, there were no reports of severe infections or febrile neutropenia during the study period.
The results suggest that satri-cel may offer a meaningful therapeutic option for patients with advanced gastric cancer, particularly when used earlier in the treatment sequence.
Advancing Toward Regulatory Review and Expanded Clinical Programs
Satri-cel is currently one of the most advanced Claudin18.2-targeted CAR T-cell therapies globally. In China, the therapy recently achieved significant regulatory milestones, including Priority Review and Breakthrough Therapy Designation from the National Medical Products Administration (NMPA). The company’s New Drug Application (NDA) for patients with advanced G/GEJA who have failed at least two prior treatment lines was accepted in June 2025.
CARsgen is also expanding development into earlier treatment settings through multiple ongoing studies, including first-line sequential therapy, perioperative treatment, and adjuvant therapy for gastric and pancreatic cancers.
The latest ASCO presentation reinforces the growing potential of CAR T-cell therapy in solid tumors, an area that has historically been challenging for cell-based immunotherapies. With durable responses extending beyond four years and a manageable safety profile, satri-cel continues to strengthen its position as a potential first-in-class treatment for Claudin18.2-positive gastric cancer.
Source: CARsgen Therapeutics press release
