Leman Biotech Co., Ltd., a clinical-stage biotechnology company advancing next-generation immunotherapies, today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Investigational New Drug (IND) clearances for three clinical trials of META 10-19, the company’s metabolically armored CD19-targeted CAR-T cell therapy.

Together with two IND clearances previously granted by the U.S. Food and Drug Administration (FDA), META 10-19 has now achieved regulatory clearances in both China and the United States. This milestone establishes the global clinical development pathway for the company’s core hematological and autoimmune programs, advancing them into registrational clinical development.

Three NMPA IND Clearances to Initiate Registrational Trials

The newly cleared INDs in China will support registrational clinical trials for the following indications:

• CXSL2600671: Adult patients with relapsed or refractory (R/R) CD19-positive B-cell acute lymphoblastic leukemia (B-ALL).
• CXSL2600672: Patients with R/R aggressive CD19-positive B-cell non-Hodgkin lymphoma (B-NHL).
• CXSL2600673: Patients with refractory systemic lupus erythematosus (SLE).

META 10 Platform: Overcoming Core Bottlenecks of Conventional CAR-T
Originating from foundational research at the École Polytechnique Fédérale de Lausanne (EPFL), Leman Biotech’s proprietary META 10 platform employs IL-10-mediated metabolic reprogramming to fundamentally reverse terminal T-cell exhaustion. This first-in-class approach addresses the critical limitations of conventional CAR-T therapies—such as T-cell exhaustion, limited efficacy and durability, high dosing requirements, severe toxicities, and prohibitive manufacturing costs—by introducing a paradigm-shifting treatment model characterized by:

• Ultra-Low Dosing: Administered at doses as low as 1/1,000 of conventional commercial CAR-T doses, significantly mitigating potential risks and production costs while maintaining robust efficacy.
• Lymphodepletion-Free Regimen: Designed to eliminate the need for intensive conditioning chemotherapy in select indications, reducing the risks of myelosuppression and severe infections, thereby expanding access to frail, elderly, or heavily pre-treated patients.
• Leukapheresis-Free Collection: Requires only approximately 50 mL of peripheral whole blood to initiate manufacturing, bypassing the traditional 3- to 6-hour apheresis process and drastically lowering the logistical burden on patients and clinical sites.
• Enhanced Persistence and Broad Applicability: The reprogrammed CAR-T cells exhibit superior in vivo expansion and an increased proportion of memory T cells. The platform is highly versatile, compatible with various cell therapy modalities (including CAR-T and TILs), and applicable across hematological malignancies, solid tumors, and autoimmune diseases.

Robust Clinical Validation from Investigator-Initiated Trials (IITs)
Prior to these registrational IND clearances, META 10-19 demonstrated strong clinical efficacy and a manageable safety profile in multiple IITs. Data from these studies have been featured at premier global conferences in oncology and advanced therapies, including AACR 2024, ASGCT 2024 (Late-Breaking Oral), and ASCO 2026. Foundational research and clinical results supporting the platform have been published in leading peer-reviewed journals, including Nature Biotechnology, Nature Immunology, JAMA Oncology, and The Lancet Haematology.

• High-Risk Diffuse Large B-Cell Lymphoma (DLBCL) (ASCO 2026): In a cohort of 14 heavily pre-treated patients with multiple high-risk factors, including bulky disease, central nervous system (CNS) involvement, and primary refractory disease, META 10-19 achieved an objective response rate (ORR) of 100% and a complete response (CR) rate of 93%. The first treated patient has maintained CR for nearly three years. The safety profile was manageable, with cytokine release syndrome (CRS) predominantly grade 1–2 and no severe immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome (IEC-HS) observed.
• B-Cell Hematological Malignancies: In an initial cohort of more than 20 heavily pre-treated patients across a broad spectrum of B-cell hematological malignancies including DLBCL, ALL, chronic lymphocytic leukemia (CLL), and mantle cell lymphoma (MCL), all patients achieved CR. Notably, deep tumor clearance was observed even in high-risk patients with severe disease or CNS involvement.
• Autoimmune Diseases (SLE): In patients with moderate-to-severe SLE, a single infusion of META 10-19 at one-thousandth of the conventional dose—without lymphodepletion or interruption of baseline immunosuppressants—induced durable remission meeting DORIS criteria. These results support a safer, more convenient “immune reset” strategy for autoimmune diseases.
• Cross-Target Validation (BCMA CAR-T): The platform’s versatility was further validated by META 10-BCMA CAR-T, a metabolically armored BCMA CAR-T candidate, which achieved deep CR and clearance of extramedullary lesions in a patient with high-risk multiple myeloma who had progressed through seven prior lines of therapy.

These robust clinical datasets underscore the platform’s scientific rigor, safety profile, and translational relevance, providing a strong foundation for the upcoming global registrational trials.

Outlook: Advancing a Global Registrational Program
The three NMPA clearances, together with the FDA clearances previously granted, mark a key step in the transition of META 10-19 from investigator-initiated studies to registrational clinical development across hematological malignancies and autoimmune disease. Leman Biotech plans to advance a coordinated global clinical development program for META 10-19 in China and the United States, accelerating the clinical translation of its META 10 platform with the commitment to delivering safer, more effective, and more accessible cell therapies to patients worldwide.

About META 10-19
META 10-19 is a novel CD19-targeted CAR-T therapy developed by Leman Biotech based on META 10, its breakthrough metabolic reprogramming technology originating from École Polytechnique Fédérale de Lausanne (EPFL), Switzerland. META 10 overcomes T-cell exhaustion through IL-10-mediated metabolic enhancement, enabling potent anti-tumor activity at ultra-low doses and potentially eliminating the need for toxic lymphodepleting chemotherapy in select indications. META 10-19 has received IND clearance from both the U.S. FDA and China’s NMPA for hematological malignancies and autoimmune disease.