Anhui, July 11, 2025 — Leman Biotech Co., Ltd., a clinical-stage biotechnology company specializing in metabolic immunotherapies, announced the official initiation of an Investigator-Initiated Trial (IIT) to evaluate Meta10-TILs, its novel metabolically armored tumor-Infiltrating Lymphocyte therapy, for the treatment of advanced solid tumors.
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The trial will be conducted at the First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital). The principal investigators are Professor Lianxin Liu, Professor Ying Zhou, and Professor Xingbing Wang — all leading clinicians and researchers at the hospital. Leman Biotech’s R&D team and the clinical investigators reviewed key trial elements, including the scientific rationale, patient eligibility criteria, dosing regimen, and safety monitoring plan.
Addressing the High Unmet Need in Advanced Solid Tumors
This IIT aims to evaluate the safety and efficacy of Meta10-TILs in patients with advanced solid tumors, including liver cancer and cervical cancer. Globally, solid tumors account for over 90% of both new cancer cases and cancer-related deaths. Their heterogeneity remains a major challenge in oncology, as it often leads to resistance, limiting the efficacy of both traditional therapies and single-target agents.
Tumor-infiltrating lymphocytes (TILs) represent one of the most promising immunotherapeutic strategies for solid tumors. Derived directly from resected tumor tissue, TILs naturally recognize a broad spectrum of tumor-specific antigens, offering a polyclonal approach to tumor killing that can overcome heterogeneity, a critical advantage over single-antigen-targeted therapies.
Meta10-TILs: A Next-Generation TIL Therapy Against Solid Tumors
Leman Biotech’s breakthrough Meta10 platform is a groundbreaking metabolic reprogramming technology designed to directly reverse terminal T-cell exhaustion — a key barrier to durable anti-tumor immunity.
In hematologic malignancies, Leman Biotech’s metabolically armored CD19 CAR-T therapy achieved a 100% complete remission rate in an initial cohort of over 20 patients with relapsed/refractory leukemia and lymphoma using ultra-low doses (as low as one-thousandth of standard commercial CAR-T doses), with most patients remaining in sustained remission.
The Meta10-TILs therapy integrates the power of TILs with the Meta10 technology, aiming to boost the TILs' resistance to exhaustion and significantly improve tumor-killing efficacy against solid tumors. Preclinical data demonstrate that Meta10-TILs exhibit significantly enhanced cytotoxicity against cervical and colorectal cancer cell lines compared to conventional TILs. In mouse models, Meta10-TILs derived from colorectal tumors completely suppressed subcutaneous tumor growth, while conventional TILs only partially inhibited it, highlighting the transformative potential of metabolic enhancement.
Trial Patient Eligibility
The trial is enrolling adult patients with advanced solid tumors, including hepatocellular carcinoma, cervical cancer (specifically refers to relapsed, metastatic, or persistent disease), and cholangiocarcinoma, who meet the following criteria:
• Histologically or cytologically confirmed diagnosis;
• Have received at least one prior line of systemic therapy;
• Have disease that is not amenable to curative surgery or radiotherapy;
• Have accessible, viable tumor tissue available for TIL isolation via resection or biopsy;
• Meet all other study-specific inclusion and exclusion criteria (to be determined by the clinical team).
Further details on this trial will be available via the clinical trial registry and participating hospital.
About Leman Biotech
Leman Biotech is a clinical-stage biotechnology company dedicated to revolutionizing cancer immunotherapy through metabolic reprogramming. Its proprietary Meta10 platform reprograms T cell metabolism to overcome key limitations of current immunotherapies, including T-cell exhaustion, poor persistence, and low response rates, with the goal of unlocking unprecedented anti-tumor activity. The company’s lead candidate, Meta10-19 CAR-T, has demonstrated remarkable efficacy in early clinical trials with ultra-low doses. Leman Biotech is advancing robust pipelines of next-generation immunotherapies for both hematologic and solid tumors.
