CARsgen Therapeutics, a company focused on innovative CAR T cell therapies for the treatment of hematologic malignancies and solid tumors, announced that CT041, an autologous CAR T-cell product candidate against the protein Claudin18.2 (CLDN18.2), has completed the first patient enrollment in the confirmatory Phase II clinical trial in Beijing Cancer Hospital in China for the treatment of CLDN18.2 positive advanced gastric/gastroesophageal junction cancer (GC/GEJ) in patients who have failed at least 2 prior lines of therapies. 

CT041 is an autologous CAR T-cell product candidate against the protein CLDN18.2 that has the potential to be the first-in-class globally. CT041 targets the treatment of CLDN18.2 positive solid tumors with a primary focus on GC/GEJ and pancreatic cancer (PC). CT041 has demonstrated promising therapeutic efficacy and favorable safety in ongoing clinical trials. CT041 has the potential to become a backbone therapy for GC/GEJ and PC in the future and benefit a large population of patients worldwide.

As of the date of the announcement, CT041 is the only CLDN18.2-targeted CAR T-cell product candidate globally that is being studied in clinical trials with IND/CTA approvals from the FDA, the NMPA, and Health Canada. In addition to the investigator-initiated trials in China, CARsgen has initiated a Phase Ib clinical trial for advanced GC/GEJ and PC, a confirmatory Phase II clinical trial for advanced GC/GEJ in China and initiated a Phase 1b clinical trial for advanced gastric or pancreatic adenocarcinoma in North America.