On August 7, 2023, Huihe Biotechnology (CytoCares) reported that the company conducted CC312 at the Hematology Hospital of the Chinese Academy of Medical Sciences (Institute of Hematology, Chinese Academy of Medical Sciences) for the treatment of relapsed/refractory patients The Phase I first-in-human trial in adult patients with CD19-positive B-cell malignant hematological tumors has completed the enrollment and administration of the first patient (Press release, CytoCares, AUG 7, 2023, View Source [SID1234635269]). Judging from the current clinical safety testing data of the first patient, the first patient tolerated it well and did not take the drug. Related adverse events occurred. The hospital and the sponsor will strictly follow the plan to conduct DLT observation and safety assessment. The main purpose of this study is to evaluate the safety, tolerability and preliminary anti-tumor activity of CC312, and to determine the maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) of CC312. As a globally innovative clinical project, its safety research is crucial to the drugability of the CC312 project.
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CC312 is the first drug for clinical use developed on the first T cell activation platform independently developed by Huihe Biotech. It is a triple drug that targets B cell surface antigen CD19, T cell antigen CD3 and T cell costimulatory molecule CD28. Specific T cell adapter (TriTE ). 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.
Mr. Huang Yingfeng, CEO of Huihe Biotech , said: "The current treatment of B-cell malignant hematological tumors cannot fully meet clinical needs, and there is an urgent need to research new treatment methods. We are very pleased to have completed the enrollment of the first patient with CC312, which is consistent with expectations. The patient’s medication process went smoothly and post-administration observation is ongoing. We will continue to rapidly advance the clinical research of CC312 and look forward to bringing safer and more effective treatment options to patients as soon as possible."