China-based chimeric antigen receptor (CAR)-T cell specialist, CARSgen Therapeutics Holdings Ltd (HKG: 2171), has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its pipeline candidate, CT041. The therapy will be assessed as a post-operative adjuvant treatment for Claudin18.2 (CLDN18.2)-positive pancreatic cancer.
Potential First-In-Class CAR-T Therapy: CT041
Developed in-house, CT041 is a potential first-in-class CLDN18.2-targeted CAR-T cell therapy under development to treat CLDN18.2 positive solid tumors, including gastric cancer/esophagogastric junction adenocarcinoma (GC/GEJ) and pancreatic cancer. This innovative therapy has shown promise in targeting tumors with high specificity, offering a new treatment option for patients with CLDN18.2-positive cancers.
Ongoing Clinical Trials and Regulatory Designations
In addition to the investigator-initiated trial in China, CT041 is also undergoing a Phase Ib/II clinical study in advanced GC/GEJ and pancreatic cancer in China and a Phase Ib/II clinical study in advanced gastric cancer or pancreatic cancer in the United States. The drug has received significant recognition, including Orphan Drug Designation (ODD) and PRIME statuses from the European Medicine Agency (EMA), and ODD and Regenerative Medicine Advanced Therapy (RMAT) designations from the US FDA in 2020 and 2021, respectively. A Phase II study for the drug in the US is expected to commence later this year, further expanding the global clinical development of CT041.-Fineline Info & Tech
