Renji Hospital First to Complete Three Post-Approval Solid Tumor CAR-T Full-Course Treatments and Efficacy Assessments

Background

CT041, also known as satricabtagene autoleucel, Shurujiolunsai injection or Kailimei, is an autologous CAR-T cell therapy product targeting Claudin18.2 (CLDN18.2). It received approval from China's National Medical Products Administration in June 2026 for the treatment of CLDN18.2-positive, HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma in patients who have failed at least two prior lines of therapy. It is reported as the world's first approved CAR-T therapy for solid tumors.

Renji Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, was among the early institutions in China to apply the therapy in clinical practice following approval. The hospital's oncology team, led by Professor Xiao Xiuying, had previously conducted T-cell collections for eligible advanced gastric cancer patients as part of establishing standardized processes for screening, assessment and full-cycle management.

What was achieved

In a development reported on 16 October 2026, the oncology team at Renji Hospital completed the full course of post-approval CT041 treatment and the first efficacy assessment for three patients with advanced gastric cancer. The full course included T-cell collection, preparation, preconditioning, cell infusion and the first post-treatment imaging evaluation. All three patients showed stable disease on their initial imaging assessment.

One of the patients, who had gastric cancer with extensive peritoneal metastasis, presented with symptoms including ascites, abdominal distension and intestinal obstruction prior to treatment. Following CT041 infusion and supportive care, these symptoms improved. The patient had a nasojejunal decompression tube and an ascites drainage tube removed and resumed normal oral intake. The tumor marker CA19-9 decreased from 1467 U/mL to 190 U/mL during follow-up. According to the report, Renji Hospital became the global center that had completed the highest number of such full-course post-approval treatments and first efficacy assessments.

How it works

CAR-T therapy uses a patient's own immune cells. The process starts with collecting T cells from the patient's blood through apheresis. In a laboratory, these T cells are genetically modified to produce a chimeric antigen receptor (CAR) on their surface. This receptor is engineered to recognize and bind to the CLDN18.2 protein, which is expressed at high levels on the surface of certain gastric cancer cells but has limited expression in normal tissues. The modified T cells are then grown in large numbers before being infused back into the patient.

Prior to infusion, the patient typically receives lymphodepleting chemotherapy to reduce existing immune cells and help the CAR-T cells engraft and expand. Once in the body, the engineered CAR-T cells seek out cancer cells displaying the CLDN18.2 target, bind to them and trigger an immune response intended to destroy the tumor cells. For solid tumors, additional engineering and preparatory approaches aim to help the cells overcome physical barriers such as dense tumor stroma and immunosuppressive signals in the tumor microenvironment.

What it means for international patients

Renji Hospital maintains an International Medical Center that serves patients from more than 40 countries and regions, including the United States, Canada, the United Kingdom, France, Japan and Malaysia. The center provides English-language support and has established partnerships with multiple international insurance providers for direct billing services where applicable. It is one of Shanghai's first 13 public hospitals designated as pilots for international medical tourism.

The availability of post-approval CT041 therapy at Renji Hospital adds to options for eligible patients with advanced gastric cancer meeting specific biomarker criteria. International patients considering this treatment must undergo comprehensive screening, including confirmation of CLDN18.2 positivity and overall medical suitability. Eligibility and suitability should be confirmed directly with the hospital's oncology team and International Medical Service, as individual cases require detailed multidisciplinary assessment.

About the hospital

Renji Hospital is a comprehensive tertiary Grade A hospital affiliated with Shanghai Jiao Tong University School of Medicine. Founded in 1844, it was the first Western medicine hospital established in Shanghai after the city opened as a treaty port. The hospital operates four main campuses (east, west, south and north) along with the Shanghai Cancer Institute.

Its oncology department is a Shanghai municipal key clinical discipline and 'priority of priorities' clinical oncology medical key discipline. The hospital has developed a Tumor Comprehensive Diagnosis and Treatment Center that emphasizes multidisciplinary team (MDT) approaches across 15 major tumor types. It maintains 13 national key clinical specialties and operates an International Medical Service certified under international standards, including DNV GL accreditation for its international services.