NEW YORK – CARsgen Therapeutics on Thursday said that China's National Medical Products Administration cleared an investigational new drug application, allowing the firm to begin studying its autologous CAR T-cell therapy CT041 in patients with CLDN18.2-positive pancreatic cancer.
Shanghai-based CARsgen is studying CT041 in multiple clinical trials. In China, the company has underway a Phase Ib trial involving patients with advanced gastric, gastroesophageal junction, and pancreatic cancer and a Phase II trial in patients with advanced gastric and gastroesophageal cancer. The company is conducting a Phase Ib/II trial of CT041 in advanced gastric or pancreatic adenocarcinoma patients in North America and is planning another Phase II trial in the US in the first half of 2023.
CT041 targets Claudin18.2, an isoform of Claudin18 that is highly expressed in gastric and pancreatic cancers. According to CARsgen, CT041 has shown promising efficacy against pancreatic cancer in preclinical studies. With the new IND clearance, it plans to investigate CT041 as an adjuvant treatment for pancreatic cancer.
The CAR T-cell therapy has been deemed an innovative medicine and granted orphan drug status by the US Food and Drug Administration and the European Medicines Agency.
In addition to CT041, CARsgen has several CAR T-cell therapies in clinical development. It is investigating Zevor-cel (CT053) in relapsed or refractory multiple myeloma patients in Phase I/II trials in China and in North America, and its GPC3-targeted CAR T-cell therapy CT011 is undergoing an investigator-initiated trial in patients with hepatocellular carcinoma.