Gelonghui, April 11 | Keji Pharmaceutical-B (02171.HK) announced that the abstract of CT041 (a candidate product targeting Claudin18.2 autologous CAR-T cells) has been received as an oral report at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

CT041 is a potentially world-first autologous CAR-T cell candidate targeting Claudin18.2 protein. It is used to treat Claudin18.2 positive solid tumors, mainly gastric cancer/esophagastric junction adenocarcinoma and pancreatic cancer. Ongoing trials include clinical trials initiated by researchers in China (CT041-CG4006, NCT03874897), confirmatory phase II clinical trials for advanced gastric cancer/esophagastric junction adenocarcinoma (CT041-ST-01, NCT04581473), phase I clinical trials for adjuvant treatment of pancreatic cancer in China (CT041-ST-05, NCT05911217), and phase 1b/2 clinical trials for advanced gastric cancer or pancreatic cancer in North America (CT041- ST-02, NCT04404595) In January 2022, CT041 was granted “Advanced Regenerative Medicine Therapy” (RMAT) certification by the US FDA to treat advanced gastric cancer/esophagastric junction adenocarcinoma positive for Claudin 18.2. In November 2021, CT041 was granted priority drug (PRIME) status by the European Medicines Agency (EMA) to treat advanced gastric cancer. In 2020 and 2021, CT041 was granted orphan drug certification by the US FDA for the treatment of gastric cancer/esophagogastric junction adenocarcinoma and the EMA certified orphan drug product for the treatment of advanced gastric cancer, respectively.