Leman Biotech Launches IIT Clinical Trial of Metabolically Enhanced CD19 CAR-T Cell Therapy for Children with Relapsed or Refractory CD19-positive B-cell Hematologic Malignancies


On March 26, 2024, the kick-off meeting of the metabolically enhanced CD19 CAR-T cell (Meta10-19 injection) IIT clinical study project, developed by Leman Biotech Co., Ltd. (hereinafter referred to as "Leman Biotech"), was held in the Hubin Campus of the Children's Hospital of Zhejiang University School of Medicine (hereinafter referred to as "Zhejiang University Children's Hospital").


This IIT clinical study is aiming to explore the safety and efficacy of Meta10-19 CAR-T cells for children with relapsed or refractory CD19-positive B-cell hematologic malignancies, with the goal of broadening treatment options for pediatric patients. Notably, the Clinical Center of Zhejiang University Children's Hospital as a key clinical research center for Meta10-19 injection, alongside the First Affiliated Hospital of the University of Science and Technology of China (Anhui Provincial Hospital) and the First Affiliated Hospital of Zhejiang University School of Medicine.


The Hematology and Oncology Center of Zhejiang University Children’s Hospital has been carrying out CAR-T cell therapy since 2015, making it one of the pioneering children's hospitals to conduct such therapy in China and possess extensive clinical and research experience. Its participation in Leman Biotech’s IIT clinical study signifies a deeper integration and expansion of Meta 10-19’s clinical applications.


Dr. Xiaojun Xu, Director of the Hematology and Oncology Center of Zhejiang University Children's Hospital, leads this Meta10-19 IIT clinical study project as the principal investigator, and hosted the in-person kick-off meeting. During this session, clinical experts and R&D personnel from Leman Biotech engaged in-depth and detailed discussions on the therapeutic mechanism of Meta10-19 injection and its clinical application. Dr. Xiaojun Xu emphasized the importance of collaboration to advance project timelines and expedite the clinical application and translation of metabolically enhanced CD19 CAR-T cell research.


Pediatric B-lymphoblastic leukemia (B-ALL) is a prevalent cancer in children. Through the continuous optimization of international standard chemotherapy and other regimens, pediatric B-ALL is generally regarded as a model of successful treatment in oncology, with a five-year overall survival (OS) rate of 89%. However, about 15% to 20% of children still do not respond to standard treatment or have a recurrence, and their five-year OS is less than 50%. Mature B-cell lymphoma is the most common pathological type of B-cell non-Hodgkin lymphoma (B-NHL) in children, which mainly includes DLBCL, BL and other subtypes. Recent years significant enhancements have been witnessed in the efficacy of this disease through intensified short-term chemotherapy combined with rituximab, achieving a 5-year event-free survival rate (EFS) exceeding 80%. However, for children with relapsed or refractory B-NHL, effective treatments to improve their survival time remain elusive.


In recent years, while CAR-T cell therapy has made great progress in treating adult hematological diseases, there remains a pressing need for further progress in addressing relapsed and refractory B-cell hematologic malignancies in pediatric patients. Despite the effectiveness of chemotherapy and other treatments, the high-dose administration often causes many adverse effects such as growth retardation in children. Therefore, there is an urgent need for novel and effective treatments for pediatric patients with B-cell hematologic malignancies.


Leman Biotech’s metabolically enhanced CAR-T cell therapy, administered at only 1%-5% of the conventional commercial dose, offers a cost-effective and low side-effect alternative. In a cohort of 20 adult patients treated with this treatment, all 20 patients reached complete remission, meanwhile the common side effects of CAR-T therapy, such as severe cytokine release syndrome, have not been observed, confirming its safety and efficacy. After a careful and meticulous investigation, clinical experts from the Hematology and Oncology Center of Zhejiang University Children's Hospital have introduced Leman Biotech's metabolically enhanced CAR-T cell therapy to pediatric patients, expecting to bring them new hope for treatment.


Patient recruitment information

At present, the IIT clinical study of Meta10-19 injection in the treatment of CD19-positive B-cell hematologic malignancies, including relapsed or refractory mature B-cell non-Hodgkin lymphoma (r/r B-NHL) and relapsed or refractory B-lymphocytic leukemia (r/r B-ALL), is underway at the Children's Hospital of Zhejiang University School of Medicine.


1. Meta10-19 Injection Product Overview

Meta10-19 injection is a novel CAR-T product developed by Leman Biotech, utilizing the breakthrough metabolic reprogramming technology of the Swiss Federal Institute of Technology in Lausanne (EPFL). Previous studies have shown that metabolic reprogramming technology can alter the fate of terminally exhausted T cells within the tumor microenvironment, shifting them from exhaustion to sustained proliferation and activation, leading to Meta10-19 CAR-T cells’ superior resistance to exhaustion and the ability to generate stem cell-like memory phenotypes. This product has achieved complete tumor clearance in various mouse tumor models and shown efficacy in preventing tumor recurrence. These results suggest that Meta10-19 CAR-T offers significant advantages in terms of efficacy and durability compared with conventional CD19 CAR-T therapies. It is anticipated to substantially enhance the complete response rate in cancer therapy and effectively reduce recurrence rates, offering promising prospects for combatting hematologic malignancies.


2. Eligible indications for participation in this study

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


3. The key criteria for participation in this study

(1) Gender: no restrictions; age: above 6 months and up to 18 years old (for infants under 1 year old, please consult with the investigator);

(2) Confirmation of positive CD19 expression by immunohistochemistry or flow cytometry;

(4) Suitable for pretreatment chemotherapy and CAR-T cell therapy as judged by the investigator;

(5) Adequate organ functions;

(6) Voluntary participation in this clinical study and provision of a written informed consent form.

For detailed enrollment criteria, please consult with the medical personnel.


4. Consultation and contact information

If you are interested in participating in this clinical study, please contact the following doctors directly or visit the Department of Hematology and Oncology at the Children's Hospital, Zhejiang University School of Medicine for further details. The doctor will provide you with detailed information about the study and conduct necessary tests according to your individual circumstances. After successful enrollment, you will receive free medication (Mate10-19 injection) and regular monitoring and follow-up appointments conducted by medical professionals.


Address: Hematology and Oncology Center, Children's Hospital Affiliated to Zhejiang University School of Medicine, No. 57, Zhugan Lane, Gongshu District, Hangzhou, Zhejiang Province

Contact number: 0571-88873611

Mobile phone: 17388794996

Email: xuxiaojun@zju.edu.cn