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.