Immunofoco's CLDN18.2 CAR-T Therapy IMC002 Demonstrates 66.7% ORR and Over One Year of Complete Remission in Advanced Gastric Cancer

Gastric cancer is one of the most common malignant tumors of the digestive tract globally and a significant cause of cancer-related deaths. According to data from the International Agency for Research on Cancer (IARC, GLOBOCAN 2020), there were approximately 1.08 million new cases of gastric cancer worldwide in 2020. A high proportion of patients are diagnosed at an advanced stage, with generally poor prognosis. The incidence of gastroesophageal junction cancer (GEJ) has been on the rise in recent years, with advanced patients often experiencing high recurrence rates and low survival rates despite undergoing multiple lines of treatment. For patients who have failed third-line or higher treatments, there are currently limited effective treatment options available, underscoring the urgent need for innovative therapies.

Recently, Immunofoco announced the latest data from the Phase I/IIa clinical study of its self-developed CLDN18.2-targeted nanobody (VHH) CAR-T product IMC002 in patients with advanced gastric cancer/gastroesophageal junction cancer (GC/GEJ) at the 2026 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI 2026). The study demonstrated that IMC002 exhibited significant potential in both safety and anti-tumor activity, providing new clinical evidence for CAR-T therapy in solid tumors.

This study is a multi-center, open-label, dose-escalation Phase I/IIa clinical trial designed to evaluate the safety, tolerability, and preliminary efficacy of IMC002 in CLDN18.2-positive advanced GC/GEJ patients who have failed multiple lines of treatment. As of August 8, 2025, a total of 16 patients received a single infusion of IMC002, all of whom were included in the safety analysis, with 15 patients evaluable for efficacy. The study provided scientific evidence for further clinical development through systematic monitoring of adverse events and tumor response.

IMC002 No ≥ occurred throughout the process.3 Grade severe adverse reactions, and none of the patients experienced dose-limiting toxicity (DLT). During the study period, not a single case occurred. 3 Grade and above cytokine release syndrome (CRS), no neurotoxicity events (ICANS), and no treatment-related deaths occurred. All treatment-related adverse events (TRAEs) are all 1–2 Grade, overall safety is controllable and tolerable. This result indicates,IMC002 In Advanced Gastric/GEJCancer patients have manageable safety, for CAR-T The application of technology in solid tumors has laid the foundation.

In 15 evaluable patients, IMC002 achieved an objective response rate (ORR) of 66.7%, demonstrating robust tumor-killing capability. The median progression-free survival (mPFS) was 7 months, and the median overall survival (OS) was 10.3 months, both significantly better than historical data from previous lines of treatment. The clinical significance lies in the fact that even in late-stage patients who failed multiple lines of therapy, IMC002 still delivered substantial anti-tumor responses, showcasing Best-in-Class potential and providing a new potential option for clinical treatment decisions.

Notably, one patient treated with the 2.5×10^8 dose group experienced complete disappearance of the tumor lesion, achieving complete remission (CR), which has been sustained for 60 weeks. This case indicates that IMC002 can induce deep and durable anti-tumor responses in some patients, suggesting the potential for long-term benefits in advanced cases. It also provides clinical evidence for subsequent research exploring curative or earlier-line treatment strategies.

IMC002 is the world's first VHH-CAR-T therapy for solid tumors to enter pivotal Phase III clinical trials.Nanobody (VHH) Design with High Targeting, Penetration, and Safety. Precisely Targets CLDN18.2 Highly Expressed in Gastric Cancer, Paving New Pathways for CAR-T Therapy in Solid Tumors and Expected to Extend to Other Solid Tumor Types with High Unmet Clinical Needs. This Technological Advantage Enables IMC002 to Maintain Potent Anti-Tumor Activity While Ensuring Safety, Setting a New Standard for CAR-T Technology in the Field of Solid Tumors.

Professor Jianming Xu, corresponding author of this study and from the First Medical Center of Chinese PLA General Hospital, stated:

IMC002 Demonstrates Controllable Safety and Significant Antitumor Activity in Patients with Advanced Gastric/GEJ Cancer, with Responses Achieved Even in Heavily Pretreated Patients. Notably, One Patient Achieved Complete Remission for Over a Year, Which is Clinically Highly Significant. The Study Results Provide Important Clinical Evidence for the Application of CLDN18.2-Targeted CAR-T Technology in Solid Tumors, and Its Excellent Safety Profile Offers Potential for Exploring Earlier-Line and Long-Term Beneficial Treatment Strategies.

Based on the results of this study, Immunofoco has initiated a Phase III randomized controlled clinical trial of IMC002 in patients with advanced GC/GEJ to further validate its efficacy and safety. This data release marks Immunofoco's continued advancement in the field of CAR-T for solid tumors, particularly for indications with high unmet clinical needs such as gastric cancer, bringing new hope for the treatment of patients with advanced gastric/GEJ cancer.

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