Leman Biotech Co., Ltd. (referred to as “Leman Biotech” or “the company”) is pleased to announce the successful treatment of the first patient using its metabolically enhanced CD19 CAR-T therapy (Meta10-19). The patient, enrolled in an investigator-initiated trial (IIT) at the First Affiliated Hospital of the University of Science and Technology of China, has achieved complete remission and was subsequently discharged from the hospital. This clinical trial (NCT05715606) was officially initiated in early 2023 to evaluate the safety and efficacy of Leman Biotech’s Metabolic Enhanced CAR-T System. The CD19, a well-studied antigen, was chosen as the therapeutic target to gather preliminary clinical data and accelerate the development of future metabolically enhanced CAR-T cell therapies for solid cancers.
This dose escalation study conducted at the First Affiliated Hospital of the University of Science and Technology of China has yielded promising results for Leman Biotech’s Meta 10-19 therapy in the treatment of patients with recurrent or refractory diffuse large B-cell lymphoma. Notably, the first patient in the study received a Meta 10-19 therapy dose equivalent to only 5% of the conventional CD19 CAR-T clinical dosage. Preliminary findings indicate that Meta10-19 CAR-T therapy exhibits remarkable safety, robust cell expansion potential, potent tumor-killing activity, and prolonged existence of CAR-T cells within the patient’s body. During the initial follow-up examination, it was confirmed that the patient achieved complete remission, indicating a clinical cure.
Significantly, the entire therapeutic procedure using Meta 10-19 therapy did not lead to any adverse events commonly associated with conventional CAR-T therapies, such as fever, cytokine storms, and neurotoxicity. These encouraging initial results highlight the potential of Meta 10-19 therapy to provide a more targeted and safer treatment option for patients with diffuse large B-cell lymphoma, underscoring its clinical significance.
The principle investigator plans to further reduce the CAR-T cell dosage to 1% or less of the conventional dose, which will greatly reduce the preparation time and cost associated with CAR-T cell therapy. This advancement holds the potential to provide high-quality CAR-T products and a more accessible treatment option for patients with recurrent or refractory diffuse large B-cell lymphoma, emphasizing the platform’s potential clinical significance and value.
Meta10-19 CAR-T Cell product developed based on Leman Biotech’s Metabolically Armed CAR-T Cell Therapy Platform, which integrates cutting-edge technologies like artificial intelligence, genome editing, immune metabolism, and synthetic biology. This platform enables the development of metabolically armed CAR-T cells that have significant advantages in overcoming T cell exhaustion and inducing the formation of stem immunological memory cells, thereby exhibiting excellent expansion potential and prolonged persistence in patients.
