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Our Department of Orthopedic Oncology has successfully enrolled the first patient in the clinical trial of TCR-T therapy for recurrent or metastatic solid tumors.


Recently, a multicenter registry clinical trial named "Phase I/II Clinical Study of TC-N201 Injection in the Treatment of Recurrent or Metastatic Solid Tumors with HLA-A2 Expression and NY-ESO-1 Positivity after Standard Therapy Failure" led by Dr. Yingqi Hua, the director of Department of Orthopedic Oncology of Shanghai General Hospital, has successfully enrolled the first patient in this center. The Department of Orthopedic Oncology of Shanghai General Hospital participated in this clinical trial as one of the research centers, and successfully conducted the first informed consent on March 12, 2024 and completed the apheresis on March 29. 


The Department of Orthopedic Oncology of Shanghai General Hospital has long been committed to the clinical researches on recurrent and refractory bone and soft tissue tumors, and has achieved a series of representative outcomes in this field. The department adheres to a development strategy that combines independent innovation with open collaboration, actively promoting the translation of basic research findings into clinical practice. In particular, the department has extensive research experience and a broad scope in the field of cellular and gene therapies. It has simultaneously advanced multiple cutting-edge clinical studies, covering cellular therapies such as TCR-T, CAR-T, TILs, genetically engineered NK cells, as well as innovative areas such as intratumoral injection of oncolytic viruses. These innovative clinical trials has provided new treatment options for patients with advanced bone and soft tissue tumors.

The indication of this project is recurrent or metastatic solid tumors with HLA type HLA-A2 and positive NY-ESO-1 expression, which have failed standard treatment.

The experimental drug is TC-N201 injection, a human NY-ESO-1 TCR-T cell injection that secretes an anti-PD-1 single-chain antibody. It is a genetically engineered TCR-T cell product. When TC-N201 injection is infused back to the patient, the modified T cells can effectively recognize the tumor antigen NY-ESO-1, specifically identifying and killing tumor cells. At the same time, it secretes anti-PD-1 single-chain antibody to block the immune checkpoint inhibition in the tumor microenvironment, thereby enhancing the efficacy of TC-N201 injection.

TCR-T therapy is a kind of T-cell therapy that involves genetically engineering cell receptors. It enhances the affinity and effectiveness of TCRs that specifically recognize tumor-associated antigens by introducing chimeric antigen receptors  or TCRα/β heterodimers into ordinary T cells. TCR-T therapy not only rapidly destroys tumors cells like chemotherapy, but also avoids the delayed effects of vaccines and T-lymphocyte checkpoint therapies. Currently, TCR-T therapy has achieved preliminary effectiveness in melanoma, liver cancer, ovarian cancer, and other tumors.

1.   T cell anergy  2. T cell activation   3. gene transduction   4 TCR-T cell expansion    5. adjuvant therapy    6 TCR-T cell reinfusion

Department Introduction

The Department of Orthopedic Oncology of Shanghai General Hospital was founded by Professor Cai Zhengdong, a renowned expert in orthopedics and bone tumors. It is one of the major centers for the diagnosis and treatment of bone and soft tissue tumors in China, specializing in the integrated discipline of bone tumor diagnosis, treatment, research, rehabilitation, and prevention. Its characteristic specialties include surgical resection and reconstruction of malignant bone tumors (extremities, pelvis/sacrum, spine), limb-saving treatment for pediatric malignant bone tumors, comprehensive/minimally invasive treatment for bone metastatic tumors, comprehensive treatment for advanced sarcomas, and clinical trials of new drugs. Both total treated cases and clinical efficacies have reached leading  levels domestically and internationally. The department is equiped with state-of -the - art medical devices. It adopts advanced concepts of surgical comprehensive treatment by providing warm humanistic care to serve numerous patients with bone tumors and bone diseases.

After ten years of construction, our department has become a key discipline of Shanghai General Hospital. It has launched a series of research projects focusing on important directions such as new surgical resection and reconstruction techniques for bone tumors, new instruments for limb-saving surgery in children, the establishment of a precision treatment system for bone tumors, and clinical researches on new treatment regimens for advanced sarcomas. A comprehensive research platform has been established, encompassing cellular and molecular researches, patient-derived xenograft (PDX) models, medical-engineering intersections, and clinical trials. In the past five years, the department has obtained over 30 national and provincial research grants, including the National Key Research and Development Program, the National Natural Science Foundation of China, and various provincial and ministerial grants. It has also won multiple talent programs such as the Shanghai Leading Talents Program, the Shanghai Oriental Talent Program, the Shanghai Youth Top Talents Program, the Shanghai Silver Snake Award, the Shanghai Science and Technology Rising Star Program, and the Shanghai Pujiang Talents Program. The department's achievements in improving the resection and reconstruction outcomes of pelvic ring tumors have received the First Prize of Chinese Medical Science and Technology Award and the Second Prize of Shanghai Science and Technology Progress Award. Researches on standardized surgery and precision treatment for osteosarcoma has also been awarded the First Prize of the Ministry of Education's Science and Technology Progress Award and the Second Prize of Shanghai Science and Technology Progress Award. The research results have been published in top-class journals such as PNAS, Nature Communications, Advanced Science, and Oncogene. New targeted drugs for osteosarcoma, innovative surgical instruments for pelvic tumors, and equipment and reagent kits for liquid biopsy of bone tumors have all been patented, all of which have obtained marketing approvals and further clinical trials are ongoing. The department has taken the lead in multiple domestic multicenter clinical studies, especially the first wave innovative clinical trials in China such as TILs cell therapy for osteosarcoma, umbrella trials of precision for osteosarcoma, and oncolytic virus combined with TCR-T therapy for bone and soft tissue sarcomas, which have improved the prognosis and quality of life for patients with bone tumors.




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