Anhui, July 16, 2025 — Leman Biotech Co., Ltd., a clinical-stage biotechnology company focused on metabolic immunotherapies, announced the initiation of an Investigator-Initiated Trial (IIT) for its novel Metabolically Armored BCMA CAR-T (Meta10-BCMA CAR-T) cell therapy.The trial will be conducted at the First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital) and aims to evaluate the safety and efficacy of Meta 10-BCMA CAR-T in patients with relapsed or refractory plasma cell neoplasms.
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The study's principal investigator, Professor Xingbing Wang, Chief Physician of the Department of Hematology and a leading expert in cellular immunotherapy, led the kick-off meeting alongside Leman Biotech’s R&D team and the hospital’s clinical staff. The meeting provided a comprehensive overview of the study's key elements, including its scientific rationale, design, participant eligibility criteria, and dosing protocol.
Addressing the Unmet Need in Relapsed/Refractory Plasma Cell Malignancies
Plasma cell disorders such as multiple myeloma (MM), plasma cell leukemia (PCL), and light-chain amyloidosis (AL) involve the malignant proliferation of plasma cells. MM is the second most common hematologic malignancy and remains incurable, with treatment primarily focused on controlling disease progression and extending survival. Most patients eventually progress to relapsed/refractory disease (r/r MM) following standard therapies, including chemotherapy. The prognosis for these patients remains poor, with a 5-year overall survival rate below 30% with conventional therapies.
While newer therapies, such as proteasome inhibitors, immunomodulatory drugs, and anti-CD38 monoclonal antibodies, have improved outcomes, most r/r MM patients experience short-lived responses or no response at all, underscoring the urgent need for revolutionary therapies.
CAR-T Therapy and the Promise of BCMA
Chimeric Antigen Receptor (CAR-T) cell therapy has emerged as a breakthrough treatment for hematologic malignancies. B-cell maturation antigen (BCMA), expressed at low levels on normal cells but highly and progressively expressed on malignant plasma cells, serves as an ideal therapeutic target. BCMA-targeted CAR-T therapies have achieved complete remission (CR) rates of 25%–80% in patients with r/r MM in clinical studies. However, durability remains a critical challenge: across studies with a median follow-up of 2–15 months, relapse or disease progression has been observed in 28% to 88% of patients.
Meta10 Technology: Designed for Enhanced Potency and Durability
Leman Biotech's Meta10-BCMA CAR-T therapy integrates the company’s metabolic reprogramming technology (Meta 10) with BCMA-targeted CAR-T cells. This design aims to enhance the persistence and anti-tumor potency of the CAR-T cells.
Preclinical data suggest that the Meta10 platform can significantly improve treatment response and efficacy while promoting the development of lasting immune memory to prevent relapse. Promising results were also observed in an earlier IIT investigating Leman Biotech's metabolically armored CD19 CAR-T therapy. In that study, the first cohort of over 20 patients with r/r leukemia or lymphoma achieved a 100% complete remission rate after receiving ultra-low doses—as low as one-thousandth of the standard commercial CAR-T dose, with no severe toxicities observed. The majority of these patients remain in sustained remission.
Trial Design and Patient Eligibility
The newly launched IIT is now enrolling adult patients with relapsed or refractory plasma cell neoplasms, including MM, PCL, and AL, who meet the following criteria:
• Have received at least three prior lines of systemic therapy;
• Have documented disease progression during or within 12 months after their most recent anti-tumor treatment;
• Have confirmed BCMA expression on plasma cells from a bone marrow sample, as determined by immunohistochemistry (IHC) or flow cytometry.
The trial will assess safety, tolerability, and preliminary efficacy. Primary endpoints include the incidence of adverse events such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), as well as efficacy measures such as overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and complete remission (CR).
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 a robust pipeline of next-generation immunotherapies for both hematologic and solid tumors.
