Tcelltech Initiated China-US Registration Clinical Trial of Targeting B7-H3 CAR-T Cells in the Treatment of Grade 4 Glioblastoma

On June 20, 2024, Fuzhou Tcelltech Inc. held the kick-off meeting of the registration phase I clinical trial targeting B7-H3 chimeric antigen receptor T cells (TX103) in the treatment of recurrent or progressive grade 4 glioblastoma in Beijing Tiantan Hospital, Capital Medical University, and began to recruit subjects. This trial is the world’s first Sino-US double-registration clinical trial of B7-H3 CAR-T cells in the treatment of glioblastoma, and will be carried out in China and the United States at the same time. In China, it was presided over by Ji Nan, director of the Department of Neurosurgery of Tiantan Hospital, and participated by the Department of Neurology of Shijitan Hospital. This is an important milestone event for Tcelltech to open the world’s leading CAR-T cell therapy for solid tumors.

The phase I clinical trial of TX103 CAR-T cell therapy for the treatment of recurrent and progressive grade 4 glioblastoma has been approved by the US Food and Drug Administration (FDA) and the Center for Drug Evaluation (CDE) of the State Drug Administration in October 2023 and January 2024, respectively. This study was designed as a single-arm, open-label, dose-escalation, multicenter cooperative trial. The main objectives of this study were to evaluate the safety of TX103 injection in the treatment of recurrent and progressive grade 4 glioblastoma, to further confirm the appropriate dose and administration, and to verify its efficacy.

Grade 4 glioblastoma is one of the most aggressive and difficult tumors to treat. The response to existing treatment methods, such as surgery, radiotherapy and chemotherapy, is very limited, and almost 100% of patients will relapse. The median survival of patients with recurrent grade 4 glioblastoma is only 6-8 months, and new treatment methods are urgently needed.

Car-t-cell therapy involves engineering a patient’s T cells to recognize and attack tumor cells. In the field of hematological oncology, CAR-T cell therapy has achieved remarkable success, but its application in the field of solid tumors is still being explored. It is exciting that the new CAR-T therapy for glioblastoma is gradually unfolding and has made significant progress.

Professor Ji Nan, the principal investigator (PI) of the trial, said: “The B7-H3 CAR-T cell therapy developed by Tcelltech, TX103, brings us new hope. B7-H3 was expressed in almost 100% of grade 4 glioblastoma and was highly expressed in 70% of patients. By targeting this target, CAR-T cells can precisely recognize and attack tumor cells.

In our previous IIT study, TX103 showed good safety and positive efficacy signals, and the results were published at this year’s ASCO meeting, which has attracted wide attention in the industry. As a neurosurgeon, I am very hopeful about the prospect of TX103. I expect that TX103 cell therapy will become a new breakthrough in the treatment of glioblastoma and bring a new light to the efficacy and survival of patients.”

About TX103

TX103 is a B7-H3 targeted CAR-T cell therapy drug independently developed by Tcelltech, with Chinese and international patent authorization. The preliminary clinical results of TX103 in the treatment of recurrent glioblastoma have been presented in the 2024 annual meeting of the American Society of Clinical Oncology (ASCO). The results of the current study show that no dose-limiting toxicity has been found in all patients so far, and it has good safety. Compared with the median survival time of 6-8 months in patients with recurrent glioblastoma, TX103 significantly improved the median survival rate and the overall survival rate of 12 months. Durable partial and complete responses were also observed in patients at the intermediate dose level.

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.