HKU-Shenzhen Hospital Successfully Applies World's First Approved Solid Tumor CAR-T Therapy

Background

Solid tumors have long presented greater challenges for CAR-T cell therapy compared to hematological malignancies. In June 2026, China's National Medical Products Administration (NMPA) approved what reports describe as the world's first CAR-T cell therapy product specifically for solid tumors. The therapy targets Claudin18.2 (CLDN18.2), a protein expressed in certain gastric and gastroesophageal junction cancers.

This approval opened new possibilities for patients with advanced disease who have exhausted standard options. One such patient was an American man named Larry from Los Angeles diagnosed with advanced gastroesophageal junction adenocarcinoma with peritoneal metastasis. After multiple treatment failures in the United States, his case brought international attention when he and his wife traveled more than 11,600 kilometers to seek care at The University of Hong Kong-Shenzhen Hospital.

What was achieved

Larry had undergone surgery, neoadjuvant therapy, multiple rounds of chemotherapy, radiotherapy, targeted drugs including ramucirumab, and later Zolbetuximab combined with chemotherapy targeting the same antigen, but his disease continued to progress. His tumor marker CA19-9 had risen to 8,200 U/mL prior to the new treatment. Biopsy of peritoneal metastases confirmed strong CLDN18.2 expression (2+/3+, positive in 99% of tumor cells).

At The University of Hong Kong-Shenzhen Hospital's International Medical Center, under the care of Vice President and oncology professor Pan Hongming, Larry received one course of the Claudin18.2-targeted CAR-T cell immunotherapy. Cell reinfusion occurred on September 29, 2026. Post-infusion, he experienced fever (up to 39°C), mild to moderate bilateral lower limb edema, and mild hypotension. These were managed with fluid supplementation and tocilizumab infusion, with related indicators stabilizing around 10 days later.

Follow-up assessments showed his CA19-9 level decreased from 8,200 U/mL before reinfusion to 57.6 U/mL. Imaging indicated the tumor had shrunk significantly, approaching complete remission. Larry was subsequently discharged. Pan Hongming highlighted three main difficulties in the case: the poor prognosis of gastroesophageal junction cancer with peritoneal spread (literature reports median survival of 3-6 months), progression after multiple lines of therapy leaving limited conventional options, and the lack of approved Claudin18.2 CAR-T products outside China at the time. He described the approval as an important advance providing a new option for target-matched late-stage digestive tract tumor patients after strict evaluation.

How it works

CAR-T cell therapy is a form of immunotherapy that harnesses and enhances the patient's own immune system. The process begins with collecting T cells, a type of lymphocyte central to immune response, from the patient's blood through apheresis. In a specialized laboratory, these cells are genetically modified using viral vectors to express synthetic chimeric antigen receptors (CARs) on their surface. These CARs consist of an antigen-recognition domain derived from an antibody, along with signaling domains that activate the T cell upon binding.

These engineered CARs are designed to recognize and bind to Claudin18.2, which is overexpressed on the surface of many gastroesophageal cancer cells but has highly limited expression in normal healthy tissues. The modified CAR-T cells are then expanded to large numbers in culture before being infused back into the patient after a preconditioning regimen. Once in the body, the CAR-T cells can proliferate, directly attack and kill the targeted cancer cells expressing the antigen, and potentially recruit additional immune responses. Treatment requires close monitoring in an experienced center for potential adverse reactions such as cytokine release syndrome or immune effector cell-associated neurotoxicity.

What it means for international patients

This case illustrates that newly approved advanced cellular therapies in China may be accessed by international patients with specific biomarker-positive advanced solid tumors who have limited options elsewhere. The University of Hong Kong-Shenzhen Hospital operates a dedicated International Medical Center that provides care for overseas patients, expatriates, and cross-border individuals from Hong Kong and Macao, incorporating management practices aligned with international standards and supporting English-language communication.

International patients considering such treatments must undergo comprehensive evaluation including biomarker testing for CLDN18.2 expression, review of disease stage, prior therapies, and overall fitness. Not all patients will qualify, and therapies carry risks of adverse reactions that require specialized management. Patients should contact the hospital directly to confirm current availability, assess individual eligibility, and discuss any required arrangements.

About the hospital

The University of Hong Kong-Shenzhen Hospital (HKU-SZH) is a comprehensive public tertiary hospital located in Futian District, Shenzhen, China. It opened on July 1, 2012, constructed by the Shenzhen municipal government with a total floor area of approximately 367,000 square meters. The hospital currently operates around 2,000 beds and is undergoing expansion toward 3,000 beds. It was established through collaboration between Shenzhen and the University of Hong Kong, which introduced advanced hospital management models and clinical expertise.

HKU-SZH attained accreditation from the Australian Council on Healthcare Standards (ACHS) in 2015 and National 3A Hospital status (China's highest tier for general hospitals) in 2017. It has been selected for Guangdong Province high-level hospital programs and as a pilot for high-quality public hospital development and international medical services. It features an International Medical Center in a dedicated building and has established centres of excellence leveraging University of Hong Kong expertise in oncology, cardiovascular diseases, orthopedics, reproductive medicine and prenatal diagnosis, among other specialties.