China-based chimeric antigen receptor (CAR)-T cell specialist CARSgen Therapeutics Holdings Ltd (HKG: 2171) has announced the initiation of patient enrollment for a Phase II clinical study of its CT041 in advanced gastric cancer/esophageal gastric junction adenocarcinoma (GC/GEJ) with positive CLDN18.2 expression that has previously failed at least second-line treatment.
CT041: A Potential First-in-Class CAR-T Cell Therapy
CT041 is a potential first-in-class CAR-T cell therapy targeting CLDN18.2, currently under development to treat GC/GEJC and pancreatic cancer. This innovative therapy has been subject to multiple Phase I/II studies in the US and China for GC/GEJC.
Regulatory Designations and Status
The drug was awarded Regenerative Medicine Advanced Therapy (RMAT) status for use in CLDN18.2 positive advanced gastric cancer in China in January 2022, highlighting its potential to address unmet medical needs. In November 2021, CT041 received Priority Medicines (PRIME) status in Europe to treat advanced gastric cancer. Additionally, it has received orphan drug designation (ODD) in the US for the treatment of GC/GEJC in 2020 and ODD status in Europe in 2021, targeting advanced gastric cancer.-Fineline Info & Tech
