March 16, 2026 — Leman Biotech Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for META 10-19, a metabolically armored CD19-targeted CAR-T cell therapy.
The IND clearance enables the initiation of U.S.-based clinical studies for patients with relapsed or refractory (R/R) CD19-positive B-cell hematologic malignancies. Targeted indications include B-cell acute lymphoblastic leukemia (B-ALL) and B-cell non-Hodgkin lymphoma (B-NHL), such as diffuse large B-cell lymphoma (DLBCL), chronic lymphocytic leukemia (CLL), follicular lymphoma (FL), and mantle cell lymphoma (MCL).
A Novel Approach to Overcome T‑Cell Exhaustion
META 10-19 is developed using Leman Biotech's proprietary META 10 platform, a first-in-class IL-10-mediated metabolic reprogramming technology designed to directly address T‑cell exhaustion—a key biological barrier to durable responses in adoptive cell therapy. By reprogramming T-cell metabolism, the platform enhances CAR-T cell persistence, functional fitness, and anti-tumor activity. This enables a pioneering "ultra-low-dose + lymphodepletion-free" treatment strategy, which aims to improve the safety, efficacy, and accessibility of CAR-T therapy.
Clinical Experience to Date
Early clinical experience from investigator-initiated trials (IITs) has demonstrated encouraging results across both oncology and autoimmune indications:
Relapsed/Refractory Leukemia and Lymphoma: In IITs, META 10-19 achieved a 100% complete remission (CR) rate in the first cohort of more than 20 treated patients using ultra‑low doses. This cohort included challenging cases with central nervous system (CNS) involvement and severe functional impairment.
Systemic Lupus Erythematosus (SLE): In a study for moderate‑to‑severe SLE, patients received META 10-19 at only 0.1% of the conventional CAR‑T dose. They achieved DORIS‑defined complete remission off all medications, without requiring lymphodepleting chemotherapy or interruption of their baseline therapy.
Mantle Cell Lymphoma: Most recently, the first patient with mantle cell lymphoma (MCL) treated without lymphodepleting preconditioning achieved complete remission, further supporting the feasibility of a lymphodepletion‑free approach in aggressive hematologic malignancies.
Global Development Outlook
This FDA IND clearance marks a pivotal milestone in the global development of META 10-19, validating its potential to address significant unmet medical needs. Leman Biotech plans to advance a coordinated global clinical development program to further evaluate the safety and efficacy of this metabolic reprogramming approach, 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.
About Leman Biotech
Leman Biotech is a clinical-stage biotechnology company focused on developing next-generation cell therapies through metabolic reprogramming. Founded in 2021 by Professor Li Tang's team from EPFL and XtalPi, the company is advancing a pipeline of metabolically armored cell therapies for oncology and autoimmune diseases. Headquartered in Shenzhen, China, Leman Biotech maintains research and development operations in both Switzerland and China. Foundational research and clinical results supporting the platform have been published in leading journals including Nature, Nature Biotechnology, Nature Immunology, and The Lancet Haematology.
Linked In post:
We are excited to share an important milestone for Leman Biotech. U.S. FDA has cleared the IND application for META 10-19, our metabolically armored CD19 CAR-T therapy—marking a pivotal step toward global clinical development.
Developed on our proprietary META 10 platform (originating from EPFL), this first-in-class IL-10-mediated metabolic reprogramming technology directly addresses T-cell exhaustion—the key barrier to durable responses in cell therapy. It enables a paradigm-shifting "ultra-low-dose + lymphodepletion-free" treatment strategy designed to improve safety, efficacy, and accessibility.
Clinical evidence to date is encouraging:
✅ 100% complete remission (CR) in >20 R/R leukemia/lymphoma patients using just 0.1%–1% of standard CAR-T dose—including CNS-involvement and severely debilitated cases
✅ DORIS-defined drug-free remission in SLE patients without lymphodepletion or therapy interruption
✅ First lymphodepletion-free mantle cell lymphoma patient achieving CR
We are driven by the goal of delivering next-generation therapies that are not only more effective but also safer and more accessible to everyone who needs them. This FDA clearance brings us one step closer.
Grateful to our world-class team, collaborators, and partners who share our commitment to translating bold science into life-changing therapies.
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