On July 7, 2023 Huihe Biotechnology (CytoCares) reported that the company cooperated with the Hematology Hospital of the Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences) (hereinafter referred to as the Institute of Hematology) (Press release, CytoCares, JUL 7, 2023, View Source;mid=2247484650&idx=1&sn=9a1343eccfaf5258fa9ca7674b70adcd&chksm=ec9976b5dbeeffa3a5b91740f2bfd72d4ba5f3e748ac24ceaf6b0fbd81a840e487be514fdc23&token=220933712&lang=zh_CN#rd [SID1234635270]). A study to evaluate the safety tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and preliminary anti-tumor activity of CC312 in adult patients with relapsed/refractory CD19-positive B-cell hematological malignancies The launch meeting of "Multi-center Phase I Clinical Research" was held in the conference room of the Phase I Ward Building, Building C of the Blood Institute. The Phase I research team led by Professor Qi Junyuan and Huihe Biotech CEO Mr. Huang Yingfeng and Huihe Biotech’s clinical team attended this meeting.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
CC312 freeze-dried powder injection (Biological Products for Therapeutic Use Category 1) is the first blockbuster drug of T cell activation platform independently developed by Huihe Biotechnology. It is a drug that targets B cell surface antigen CD19, T cell antigen CD3 and T cell co- Recombinant trispecific T-cell engager (TriTE ) based on the stimulatory molecule CD28. CC312 can form a bridge between tumor cells (B cells) and T cells, and coordinately regulates T cells by activating the CD3 signaling pathway of T cells and the costimulatory signal CD28 pathway, inducing long-lasting and sustained T cell activation, making T cells Kill tumor cells more effectively. Preclinical studies have shown that CC312 exhibits significant anti-tumor activity in tumor cell lines expressing CD19 antigen, and is expected to provide better treatment options for patients with CD19+ refractory/relapsed B-cell malignancies. In addition, preclinical safety data indicate that CC312 is well tolerated in Hu-HSC mice and cynomolgus monkeys, and no administration-related toxicological abnormalities were observed in histopathological studies.
This study will recruit patients with relapsed/refractory CD19-positive non-Hodgkin lymphoma (NHL), including indolent and aggressive B-cell NHL, to evaluate the safety and tolerability of CC312 in this population; explore the dose limitations of CC312 toxicity (DLT), and determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D).
Hematology Hospital, Institute of Hematology, Chinese Academy of Medical Sciences Graduated from Shandong Medical University in 1990. He has done basic medical research abroad for 5 years. In 2005, he returned to the Hematology Hospital (Institute of Hematology), Chinese Academy of Medical Sciences and has been working ever since. Currently working in the new drug clinical trial ward of the hospital, he is mainly engaged in the diagnosis and treatment of blood diseases and new drug clinical trials. He is good at the diagnosis and identification of hematological diseases, as well as the individualized overall treatment of hematological tumors (including lymphoma, myeloma, leukemia, etc.).
At the kick-off meeting, PI Professor Qi Junyuan’s team and Huihe’s clinical team discussed and exchanged information on the "CC312-001 Project Clinical Plan". The discussion was lively and the participating experts actively had in-depth discussions and reached consensus on the protocol design, primary endpoints of the study, inclusion criteria, patient screening and other aspects.
Currently, except for Sanofi’s two tertiary antibodies based on dual-signal activation of T cells, there are no clinical reports of dual-signal-activated T-cell-related tertiary antibodies in China. The launch of Huihe Biotech’s CC312 clinical project hopes to effectively help patients with relapsed/refractory CD19-positive non-Hodgkin lymphoma (NHL) reduce their pain and restore health.