Leman Biotech Announces First Pediatric Patient Discharged in Metabolically Enhanced CD19 CAR-T Clinical Trial

The child recently received Leman's metabolic-enhanced CD19 CAR-T cell therapy at the Children's Hospital of Zhejiang University School of Medicine (referred to as "ZU Children’s Hospital"). Prior to enrollment, the child had been diagnosed with relapsed and refractory acute B lymphoblastic leukemia (high-risk type) accompanied by central nervous system metastasis. After undergoing four lines of treatment, the condition remained uncontrollable, leaving the child in a situation where no effective drugs were available. Fortunately, ZU Children’s Hospital launched the IIT clinical research for Meta10-19 injection at the end of March 2024, led by Director Xu Xiaojun from the Hematology-Oncology Center as the principal investigator (PI) of the study. After evaluation, the child met the basic eligibility criteria for the Meta10-19 injection clinical study and became the first pediatric patient successfully enrolled in the IIT clinical research for Meta10-19 injection. Due to the urgency of the condition, the medical team at ZU Children’s Hospital closely collaborated with Leman's clinical team. After meticulous preparation and careful arrangements, the child received treatment with an extremely low dose (1% of the standard dosage) of Meta10-19 injection within the shortest possible preparation time. Encouragingly,Shortly after treatment, the child's condition showed significant improvement, with tumor cells effectively eliminated, eventually reaching a state of complete remission (CR).Throughout the treatment process, the child's physiological signs remained very stable, without severe side effects such as a cytokine storm.

In recent years, approximately 11,000 new cases of pediatric acute B lymphoblastic leukemia (B-ALL) have been reported annually in China. With the continuous optimization of international standardized chemotherapy regimens and other protocols, the five-year overall survival rate (OS) has reached nearly 90%. However, around 2,000 pediatric patients who either fail to respond to standard treatments or experience relapses continue to face a lack of effective therapeutic options. This distressing situation brings endless sorrow and regret to the affected families and society.

CAR-T cell therapy has made significant progress in the field of adult hematological diseases, with more than ten CAR-T therapies approved for marketing worldwide. However, so far, there is no CAR-T cell therapy available for pediatric patients in China, and internationally, there is only one, which is extremely expensive. Therefore, there is an urgent clinical need for an "affordable" CAR-T suitable for children with acute leukemia! Metabolism-enhanced CAR-T cell therapy developed by Leman Biotech Co., Ltd. based on its unique metabolic reprogramming technology can significantly enhance the expansion and persistence of CAR-T cells, effectively overcoming T-cell exhaustion and improving therapeutic efficacy. In preclinical studies,Metabolism-Enhanced CAR-T CellsDemonstrated a cure rate of up to 100% in models of hematologic tumors and multiple solid tumors; in the IIT clinical study, more than 20 adult patients have been treated, all achieving CR and being discharged. This successful treatment of pediatric patients not only marks significant progress for Leman Biotech Co., Ltd in the clinical research of childhood malignant hematologic tumors but also brings new treatment options and hope to children suffering from related malignant blood cancers.

It is worth mentioning that,The input dose of the metabolism-enhanced CD19 CAR-T cell therapy is only 1% of the conventional CD19 CAR-T dose, effectively reducing severe side effects such as cytokine storms associated with cell therapy.An extremely low dose (1% of the conventional dose) also means significantly shorter production time, with the potential for rapid production using small automated equipment, further reducing production costs and enhancing the accessibility of this therapy.

With the successful discharge of the first pediatric patient, the IIT clinical research on Leman Biotech's metabolism-enhanced CD19 CAR-T cell therapy will continue to advance in order to further verify its safety and efficacy. Meanwhile, the research team will also explore its potential applications in a wider range of hematological malignancies. Leman Biotech will collaborate with top medical institutions and research teams both in China and internationally to jointly promote the research and clinical application of metabolism-enhanced cell therapies, bringing new hope to more patients.

A clinical study on the safety and efficacy of metabolism-enhanced CD19 CAR-T cell injection for the treatment of relapsed or refractory CD19-positive B-cell hematologic malignancies is being conducted at the Children's Hospital of Zhejiang University School of Medicine. Patient recruitment information is as follows:

Meta10-19 Injection is a novel CAR-T product (targeting CD19) developed by Leman Biotech Co., Ltd, which introduces the breakthrough metabolic reprogramming original technology from the Swiss Federal Institute of Technology Lausanne (EPFL). Preliminary studies have shown that metabolic reprogramming technology can shift the fate of CAR-T cells in the tumor microenvironment from exhaustion and dysfunction to sustained proliferation and activation, thereby enabling Meta10-19 CAR-T cells to exhibit an exceptional ability to resist exhaustion and generate stem cell-like memory phenotypes. This product has achieved complete tumor eradication in various mouse tumor models and effectively resists tumor recurrence. These findings suggest that compared with traditional CD19 CAR-T, Meta10-19 CAR-T demonstrates significant advantages in terms of efficacy and durability, with the potential to markedly increase the complete response rate (CR) in cancer treatment and effectively reduce recurrence rates, offering promising prospects for overcoming hematologic malignancies.

Diagnosed with relapsed or refractory mature B-cell non-Hodgkin lymphoma (r/r B-NHL), relapsed or refractory acute B lymphoblastic leukemia (r/r B-ALL), etc., including pediatric patients with CD19-positive B-cell hematologic malignancies who have undergone conventional CAR-T treatment but showed poor response or relapsed after achieving complete remission (CR).

For more eligibility criteria, please consult your doctor.

If you are willing to participate in this clinical study, please contact the following doctor directly or visit the Department of Hematology and Oncology at the Children's Hospital affiliated with Zhejiang University School of Medicine for further information. The doctor will provide you with a detailed introduction to this study and, based on your specific situation, arrange for relevant examinations. Upon successful enrollment, we will provide you with free medication (Mate10-19 Injection) and professional medical staff will conduct regular observations and follow-ups.

Address: Department of Hematology and Oncology, Children's Hospital of Zhejiang University School of Medicine, No. 57 Zhugan Alley, Gongshu District, Hangzhou City, Zhejiang Province

Contact Number: 0571-88873611

Email: xuxiaojun@zju.edu.cn

Expert Outpatient Consultation:

Director Xu Xiaojun: Monday all day (Hubin Campus)

Director Tang Yongjun: Tuesday morning, Friday morning (Hubin Campus)

Deputy Director Liao Chan: All day Friday (Binjiang Campus)

Director Xu Xiaojun

Director Xu Xiaojun

Ph.D., Chief Physician, Doctoral Supervisor

Director of the Department of Hematology and Oncology, Children's Hospital, Zhejiang University School of Medicine

Member of the Hematology Group, Pediatric Branch, Chinese Medical Association

Standing Committee Member of the Pediatric Oncology Professional Committee of the Chinese Anti-Cancer Association

Secretary General of the Other Hematological Diseases Committee of the National Health Commission's Expert Committee on Children's Hematological Malignancies and Solid Tumors

Group Leader of the Hematology and Oncology Group, Pediatrician Branch, Zhejiang Province Medical Association

Deputy Group Leader of the Hematology Group, Pediatric Branch, Zhejiang Medical Association

Vice Chairman of the Pediatric Oncology Committee of the Zhejiang Anti-Cancer Association

Standing Committee Member of the Hematology Branch of Zhejiang Medical Association

Standing Committee Member of the Hematology and Lymphoma Professional Committee of the Zhejiang Anti-Cancer Association

Invited Editorial Board Member of "Chinese Journal of Organ Transplantation"

World Journal of PediatricsYouth Editorial Board

Zhejiang Province Medical Rising Star (2015）

Zhejiang Province151Talent (2017）

National Standardized Training for Resident Physicians“Excellent Teaching Teacher”（2018）

Zhejiang Provincial Health Innovative Talent (2022）

2013.1-2014.1Conducted postdoctoral research at the University of Pennsylvania, USA (in the field of cancer immunotherapy)

Lead National and Provincial/Ministerial Level Scientific Research Projects6Item, first or corresponding author publishedSCIPaper30More than...

Main Research Areas: Hemophagocytic Lymphohistiocytosis (HLH) in Children, Immunotherapy for Pediatric TumorsCellTreatment and Hematopoietic Stem Cell Transplantation