GT201 TIL Therapy Achieves Complete Response in First Oral Cancer Patient: A Global First-in-Class mbIL-15 Engineered Cell Therapy Shows Promising Clinical Results

Disclaimer: Due to limited proficiency, errors are inevitable, and some information may not be the most up-to-date. Feel free to point out in the comments. This article is only for the introduction of medical and health-related drugs, not a recommendation of treatment plans (if involved); this article does not constitute any investment advice.

Recently, Director He Yue from the Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine led a clinical study on gene-edited tumor-infiltrating lymphocytes (TIL).The study titled "GT2 01 Injection Combined with PD-1 Inhibitor for the Treatment of Advanced Squamous Cell Carcinoma of the Head and Neck" successfully completed the first cell infusion treatment in a patient with oral cancer at Shanghai Ninth People's Hospital.

This 61-year-old male patient had been successfully treated with surgery and chemoradiotherapy for laryngeal cancer in 2016. However, in September 2023, he was diagnosed with floor-of-mouth cancer, accompanied by mandibular invasion and multiple cervical lymph node metastases. Due to concerns about severe complications from surgery, he opted for non-surgical treatment. Unfortunately, chemotherapy and targeted therapy proved ineffective, and the tumor continued to progress.Learned that Shanghai Ninth People's Hospital is conducting TIL cell therapy.After the legal clinical trial, the patient decided to join.He successfully passed the screening and underwent a comprehensive treatment process at Shanghai Ninth People's Hospital, including lesion sampling, bridging therapy, TIL preparation and reinfusion, etc.Despite the occurrence of adverse reactions such as chills and fever during the treatment process, the overall safety was controllable, and normal conditions were restored after symptomatic treatment.

Only 3 weeks after TIL infusion, the patient's lesion significantly reduced, reaching a partial clinical response.Partial Remission (PR). At the 9-week follow-up, radiological assessment showed that all lesions of the patient had completely disappeared, achieving complete remission.

Comparison of PET-CT Images Before and After Treatment (Shanghai Ninth People's Hospital)

Comparison of PET-CT Images Before and After Patient TreatmentIn September 2023, Professor He Yue's research group collaborated with Grail Bio to apply for the second round of the "Three-Year Action Plan to Promote Clinical Skills and Clinical Innovation in Municipal Hospitals" by the Shanghai Shenkang Hospital Development Center. The He Yue team from the Ninth Hospital is responsible for designing and conducting clinical trials targeting squamous cell carcinoma of the oral cavity and head and neck.

Project leader Professor He Yue introduced: "The 5-year survival rate for patients with head and neck squamous cell carcinoma (HNSCC) who failed first-line treatment is only about 20%, with very limited treatment options. GT201, independently developed by Shanghai Grail Bio Co., Ltd., is a membrane-bound IL-15 complex-engineered TIL therapy that enhances the persistence and functionality of TIL cells while reducing the immunosuppressive effects in the tumor microenvironment. This provides a new treatment option for patients with advanced HNSCC who failed first-line treatment. The preliminary results of this clinical study show that GT201 demonstrates good safety and encouraging efficacy in patients, building confidence for subsequent research and offering a new path for the new paradigm of medical-enterprise cooperation."

In February 2024, Lifileucel, the world's first TIL therapy product, was approved for marketing with a price tag of $515,000. In contrast, China’s independent research and development of TIL therapy and clinical trials have made significant progress, providing Chinese patients with more accessible treatment options. The Department of Oral and Maxillofacial Head and Neck Oncology at Shanghai Ninth People's Hospital, under the joint efforts of Professor Xize Zhang, Academician Weiliu Qiu, and Academician Zhiyuan Zhang, has become a leading discipline both domestically and internationally. Since 2019, the Zhiyuan Zhang research team has conducted extensive R&D explorations in collaboration with Grail Bio, guiding Dr. Rong Zhou and Dr. Yong Han of the research group in completing applications for multiple projects, including the National Natural Science Foundation.

Academician Zhang Zhiyuan of the Chinese Academy of Engineering stated: "We began exploring tumor-infiltrating lymphocyte therapy more than 30 years ago, but at that time, limited by technical conditions, the results were unsatisfactory. Today, with advancements in the industry, the preliminary efficacy demonstrated by the new edited tumor-infiltrating lymphocyte therapy undoubtedly brings new hope to patients with head and neck cancer. In the future, our department will rely on the advantageous resources of the National Center for Stomatology to focus on building immunotherapy wards and a research platform, promoting the development of key technologies in immune cell therapy, and providing continuous momentum for the development of Chinese-style oral and maxillofacial head and neck oncology."

Reference: Official materials from Shanghai Ninth People's Hospital