CARsgen Therapeutics Holdings Ltd (HKG: 2171), a leading China-based developer of chimeric antigen receptor (CAR)-T cell therapies, has announced the completion of patient enrollment in a confirmatory Phase II clinical trial for its investigational CAR-T therapy, CT041. The study aims to evaluate CT041 as a potential treatment for advanced gastric cancer and gastroesophageal junction adenocarcinoma (GC/GEJ) in China.
This open-label, multi-center, randomized, controlled trial is designed to assess the efficacy and safety of CT041 in patients with CLDN18.2-expressing advanced GC/GEJ, specifically in a third-line treatment setting. The control group will receive investigator-selected treatments, which may include paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab.
CT041 is positioned as a potential first-in-class CAR-T cell therapy targeting CLDN18.2. The therapy has garnered significant regulatory attention, receiving Regenerative Medicine Advanced Therapy (RMAT) designation in the U.S. for CLDN18.2-positive advanced gastric cancer in January 2022, as well as Priority Medicines (PRIME) status in Europe in November 2021. Additionally, it was granted orphan drug designation (ODD) in both the U.S. and Europe for advanced gastric cancer in 2020 and 2021, respectively. However, in December 2023, CARsgen suspended studies for CT041 and two other CAR-T therapies in the U.S. after filing Corrective and Preventive Actions (CAPAs) with the FDA in April.- Flcube.com
