Leman Biotech Initiates Investigator-Initiated Clinical Trial of its Metabolically Enhanced CD19 CAR-T Therapy for the Treatment of Moderate to Severe Active Systemic Lupus Erythematosus (SLE)

11.28
2024

Hangzhou, November 28, 2024 - the First Affiliated Hospital of Zhejiang University School of Medicine successfully held the clinical launch meeting to include moderate to severe active systemic lupus erythematosus (SLE) into the investigator-initiated clinical trial (IIT) for the metabolically armed CD19 CAR-T cells (Meta10-19 Injection).

 

About Systemic lupus erythematosus (SLE)


Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by the immune system attacking the body’s own tissues, leading to multi-organ damage. Based on disease activity and severity, SLE is classified into:

  • Mild SLE: Minimal symptoms with no major organ involvement.
  • Moderate SLE: Symptoms include organ damage such as arthritis, extensive rashes, vasculitis, or serous effusion.   
  • Severe SLE: Life-threatening involvement of organs such as kidneys, brain, lungs, or blood, including conditions like rapidly progressive glomerulonephritis, neuropsychiatric lupus, lupus pneumonitis, and thrombotic thrombocytopenic purpura (TTP).


While conventional treatments (e.g., NSAIDs, antimalarials, immunosuppressants, and corticosteroids) alleviate symptoms, they often lead to severe side effects and a high risk of relapse. Therefore, more effective, targeted therapies are urgently needed.


Research has shown that abnormal B cell activation as central to SLE pathogenesis. B cells are involved in autoantibody production and immune dysregulation, making them a prime therapeutic target. Emerging evidence supports the use of CAR-T therapy, particularly CD19 CAR-T cells, as a breakthrough in SLE treatment, with clinical trials demonstrating promising efficacy and the potential to transform the disease trajectory.

 

Patient Recruitment Information


1.Introduction to Meta10-19 Injection


Meta10-19 therapy, a metabolically armed CD19 CAR-T therapy, is a novel CAR-T product (targeting CD19) developed by Leman Biotech based on breakthrough metabolic reprogramming technology from the Swiss Federal Institute of Technology Lausanne (EPFL).


Preclinical studies have shown that metabolic reprogramming transforms the behavior of CAR-T cells within the tumor microenvironment, enabling them to overcome exhaustion and sustain long-term proliferation and activation. Metabolically armed Meta10-19 CAR-T cells with exceptional resistance to exhaustion while promotion a stem cell-like memory phenotype. In various murine tumor models, Meta10-19 therapy achieved complete tumor clearance and demonstrated strong resistance to relapse. Notably, metabolically Armed CAR-T therapy requires an ultra-low dosage—significantly lower than traditional CD19 CAR-T therapies—while maintaining superior efficacy and safety. These findings highlight its potential to substantially enhance complete response (CR) rates in hematologic malignancies and minimize relapse risk.


2. Eligibility Criteria


Condition: Adult patients diagnosed with moderate to severe active systemic lupus erythematosus (SLE).


3. Contact Information


The First Affiliated Hospital of Zhejiang University School of Medicine

  • Investigator: President Huang He
  • Outpatient Clinics:

                    Tuesday morning (Qingchun Campus)

                    Thursday morning (Yuhang Campus)

  • Investigator: Director Hu Yongxian
  • Outpatient Clinics:

                     Monday morning (Qingchun Campus)
                     Thursday morning (Yuhang Campus)

                     CAR-T Specialty Clinic: Friday morning (Yuhang Campus)

  • Phone: 0571-87233782
  • WeChat: CARTcells
  • Address: Doctor's Office, Bone Marrow Transplantation Center, Hematology Department, East Wing, 6th Floor, Building 3, Headquarters Phase I (Yuhang Campus), First Affiliated Hospital of Zhejiang University School of Medicine.