Anhui, April 26, 2025 - Leman Biotech Co., Ltd. ("Leman Biotech"), a clinical-stage biotechnology company focused on the research, development, production, and commercialization of innovative metabolic immunotherapies, recently announced the successful treatment of the first patient enrolled in its investigator-initiated clinical trial (IIT) for relapsed/refractory chronic lymphocytic leukemia (R/R CLL). The patient, treated with an extremely low dose, was assessed to have achieved complete remission (CR) and was discharged successfully.
The patient had been diagnosed with chronic lymphocytic leukemia (CLL) following evaluation for cervical lymphadenopathy (swollen lymph nodes in the neck). Despite undergoing four prior lines of treatment, the disease continued to progress. After receiving Leman Biotech’s ultra-low-dose CAR-T therapy, a comprehensive clinical assessment confirmed complete remission. The patient was subsequently discharged without complications. Notably, no severe cytokine release syndrome (CRS), significant neurotoxicity, or other common CAR-T-associated adverse effects were observed during treatment.
About Chronic Lymphocytic Leukemia (CLL)
Chronic lymphocytic leukemia (CLL) is a clonal proliferative malignancy of mature B lymphocytes, typically affecting middle-aged and elderly individuals. It is characterized by a distinctive immunophenotype and marked by the accumulation of lymphocytes in peripheral blood, bone marrow, spleen, and lymph nodes. CLL is among the most prevalent forms of adult leukemia in Western countries, accounting for approximately 30% of adult leukemia cases.
In contrast, the incidence of CLL in China and Japan is significantly lower—about 10% of that in Western populations. However, with rapid economic development, lifestyle changes, and advancements in diagnostic technologies, the detection rate of CLL in China has been steadily increasing, making it an emerging hematologic malignancy of public health concern.
Current Treatment Landscape for Relapsed/Refractory CLL (R/R CLL)
Over the past decade, small-molecule targeted therapies—particularly Bruton’s tyrosine kinase (BTK) inhibitors—have transformed the treatment of CLL, gradually replacing chemoimmunotherapy as the standard of care. Widely used agents such as acalabrutinib and zanubrutinib have significantly improved patient outcomes. However, 20–30% of patients still progress to relapsed or refractory CLL, where effective treatment options remain limited.
The emergence of CAR-T cell therapy has introduced a promising new avenue for these patients. In March 2024, the U.S. FDA granted accelerated approval to Bristol Myers Squibb’s Breyanzi (lisocabtagene maraleucel, or liso-cel), marking it as the world’s first—and currently only—CAR-T therapy approved for R/R CLL. Pivotal Phase I/II trials demonstrated a complete remission (CR) rate of approximately 20% in patients who had failed both BTK and BCL-2 inhibitor therapies. While this approval represents a critical milestone, the modest CR rate underscores the pressing need for next-generation CAR-T approaches with enhanced efficacy.
About the Ultra-Low-Dose Metabolically Armed CD19 CAR-T Therapy
Leman Biotech’s metabolically armed CD19 CAR-T therapy (Meta10-19 Injection) is a novel therapeutic developed using the company’s proprietary metabolic reprogramming platform. In preclinical models, the therapy achieved complete tumor eradication and successfully prevented tumor recurrence.
In its ongoing investigator-initiated clinical trials (IIT), more than 20 patients with relapsed or refractory leukemia or lymphoma have been treated. All achieved complete remission (CR) and were discharged without severe adverse effects. Remarkably, the treatment was effective at an ultra-low dose—can be as low as one-thousandth (0.1%) of the standard commercial CAR-T cell dose.
Following these promising results, the Meta10-19 CAR-T therapy program has expanded to include patients with relapsed/refractory indolent non-Hodgkin lymphoma and those with moderate-to-severe systemic lupus erythematosus (SLE), broadening its clinical applicability beyond oncology.
