NEW YORK – Carsgen Therapeutics said on Thursday that it will begin a China-based Phase II trial of its autologous CAR T-cell therapy CT041 for certain patients with advanced gastric and gastroesophageal junction cancers.
Specifically, the Shanghai-based firm said that China's Center for Drug Evaluation of the National Medical Products Administration has approved Carsgen's plans to begin a confirmatory Phase II trial evaluating CT041 as a treatment for patients with Claudin 18.2 (CLDN18.2)-positive advanced gastric or GEJ cancers after two prior lines of treatment.
The Phase II trial will follow the firm's Phase Ib trial, in which advanced CLDN18.2-positive gastric, GEJ, and pancreatic cancer patients treated with CT041 lived a median of 5.6 months without their cancers progressing. The objective response rate was 61.1 percent. In contrast, the median progression-free survival of currently available treatment options for these advanced patients is about two months, according to Lin Shen, the CT041 study's principal investigator.
The autologous CAR T-cell therapy involves harvesting patients' immune cells, engineering them to target the protein CLDN18.2, then reinfusing them as a one-time treatment. To be eligible for the therapy in the clinical trial, patients' tumors had to have expressed the CLDN18.2 protein in at least 10 percent of cells, as determined by immunohistochemistry staining.
Carsgen is also studying the therapy outside of China and hopes to begin a Phase II trial in North America this year. In 2020, the therapy received orphan drug designation from the US Food and Drug Administration for advanced gastric and GEJ cancers, and in 2021, it received orphan medicinal product designation from the European Medicines Agency for advanced gastric cancers. The EMA also granted the therapy priority medicines, or PRIME, designation this past fall, and the FDA granted it regenerative medicine advanced therapy designation last month.