Tcelltech CAR-T Cell IND Approved for Brain Tumor Treatment

On January 22, 2024, Tcelltech’s “TX103 CAR-T cell” was approved by the National Center for Drug Evaluation (CDE) IND for the treatment of malignant glioma.

TX103 is an original CAR-T cell therapy drug targeting B7-H3 (CD276). The drug received FDA clinical trial approval in September 2023; It has also been granted orphan drug designation by the US FDA in June 2023.

TX103 is a B7-H3 targeted CAR-T cell therapy drug independently developed by Tcelltech, with Chinese and international patent authorization. TX103 has been shown to be safe and effective in the treatment of recurrent malignant glioma in early clinical trials. Malignant gliomas have a high degree of malignancy, among which GBM is the most common. It is easy to relapse after surgery, and there is a lack of effective treatment after recurrence. B7-H3 is highly expressed in glioma tumor cells, which can serve as an immune checkpoint to help tumor cells escape, and give tumor cells a more aggressive phenotype. Therefore, the high expression of B7-H3 is related to tumor invasion and poor prognosis. Since the central nervous system has a blood-brain barrier and is an “immune-exempt zone”, which is an important challenge for drug therapy, CAR-T cells as a living immune cell drug have special advantages in the treatment of glioma.

TX103 was successfully approved IND in China and the United States, marking an important progress in the development of Tiancheng CAR-T cell drugs in the treatment of malignant glioma in China and the United States. In the next step, we will carry out comprehensive international multi-center clinical trials, and look forward to bringing new treatment methods and more survival benefits to patients as soon as possible.

About Tcelltech
Tcelltech is an innovative biomedical company in clinical stage, focusing on the development of T cell immune products. It was co-founded by Professor Chen Liping, a pioneer in tumor immunology, and Professor Huang Gangxiong, an expert in immune cell therapy. With the mission of research and innovation, the company focuses on the development of innovative technologies and drugs for tumor immunity and immune cell therapy, and has established a professional team covering the whole drug development process of scientific research, technology development, quality management, production process and registration, and clinical research. Under the leadership of Professor Chen Liping, the team of Tcelltech is committed to developing global innovative immunotherapy drugs to bring new hope to more cancer patients in the face of unmet medical needs.

Gangxiong Huang, MD

Co-founder, CEO

Dr. Huang’s research has focused on tumor metastasis and T-cell immunotherapy. He completed his postdoctoral training and subsequently served as a researcher at The University of Texas MD Anderson Cancer Center. He also served as a pathologist and Minjiang Scholar Professor at Fujian Medical University previously.

Lieping Chen, MD, PhD​

Co-founder, Scientific advisor

Dr. Chen is a pioneer in cancer immunotherapy. His research focuses on fundamental T-cell biology and the translation of scientific discoveries into clinical therapies, with a primary emphasis on cancer immunotherapy. He discovered PD-L1 and established its role in tumor immune evasion, laying the foundation for anti-PD-1/PD-L1 therapies that have transformed cancer treatment worldwide. Among his other numerous discoveries, B7-H3 has emerged as a promising universal therapeutic target for solid tumors. 

Dr. Chen is United Technologies Corporation Professor in Cancer Research and Professor of Immunobiology, of Dermatology and of Medicine at Yale University. He held faculty positions at the Mayo Clinic, Johns Hopkins University, and scientist positions in the Bristol-Myers Squibb Co. before joining Yale University. Dr. Chen is a member of the National Academy of Sciences, the National Academy of Medicine, and a Fellow of the American Association for Cancer Research.