Leman Biotech Initiates IIT Clinical Study of Metabolically Enhanced Tumor-Infiltrating Lymphocyte Therapy (META 10-TILs) for Advanced Solid Tumors

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Previously, this therapy had been initiated in the First Affiliated Hospital of the University of Science and Technology of China for IIT clinical research (Clinical Progress | The IIT Clinical Research Project of Metabolism-Enhanced Tumor-Infiltrating Lymphocytes (META10-TILs) for the Treatment of Advanced Solid Tumors Officially Launched). This successful launch at the National Cancer Prevention and Control Center — the Cancer Hospital of the Chinese Academy of Medical Sciences — further accelerates the clinical exploration of META 10-TILs therapy across various solid tumor indications.

ThisThe study was jointly led by several senior oncology experts, includingProfessor Li Ning from the Cancer Hospital of the Chinese Academy of Medical Sciences served as the Principal Investigator (PI), with Professor Wang Shuhang and Dr. Miao Huilei serving as co-investigators.Leman Biotech Co., Ltd.'s R&D team, together with the heads of clinical departments, nursing teams, and relevant personnel responsible for ethical review, attended the meeting. At the launch conference, Leman Biotech's R&D team systematically introduced the research background, clinical trial design, subject eligibility criteria, cell preparation process, dosing procedures, and key points of safety monitoring for the META 10-TILs therapy. Both parties engaged in in-depth discussions on critical issues such as enrollment strategies, efficacy evaluation, and adverse reaction management, laying a solid foundation for the high-quality advancement of the subsequent project.

This IIT study aims to evaluate the safety and preliminary efficacy of META 10-TILs in patients with advanced solid tumors. The study plans to enroll patients with advanced solid tumors confirmed by histopathology or cytology, including those who have failed prior standard treatments (disease progression or intolerance), have no current standard treatment options, or are unable to tolerate the current standard treatment for other reasons. Tumor types will cover lung cancer, colorectal cancer, melanoma, etc. These patients generally face the dilemma of limited treatment options and poor prognosis, urgently requiring novel therapeutic approaches.

Tumor-Infiltrating Lymphocytes (TILs) are a heterogeneous group of lymphocytes localized in the tumor microenvironment. Compared with lymphocytes derived from peripheral blood, they are considered to have stronger and more specific anti-tumor activity. TILs therapy is a type of adoptive cellular immunotherapy. The process involves isolating TILs from the patient's tumor tissue, activating and expanding them in vitro, and then reinfusing them into the patient’s body to target and kill tumor cells. Currently, this therapy has demonstrated significant efficacy in refractory tumors such as melanoma and is gradually being applied in clinical practice.

Leman Biotech Co., Ltd. has developed a metabolic-enhanced tumor-infiltrating lymphocyte therapy, which is independently researched and developed by the company.META 10 Metabolic Reprogramming Technology Combined with Traditional TILs TherapyThis technology, while retaining the broad-spectrum ability of TILs to recognize tumor-specific antigens, significantly enhances their resistance to exhaustion, thereby improving the survival and killing efficiency of TILs in the solid tumor microenvironment. META 10 technology is currently a unique approach in the field of cancer immunotherapy capable of directly modulating terminally exhausted T cells. In hematological malignancies, the metabolically enhanced CAR-T therapy developed based on this technology achieved complete remission (100% CR) in all of the first 20+ enrolled patients with relapsed/refractory leukemia/lymphoma at an extremely low dose (as low as 1‰ of commercial CAR-T doses), preliminarily confirming the safety and efficacy of the technology. In the field of solid tumors, preclinical studies show that META 10 technology can significantly improve immune response rates and cure rates in solid tumors, demonstrating great potential for overcoming solid cancers.

Source: Leman Biotech