CARsgen Therapeutics announced that the U.S. FDA lifted the clinical holds on trials of three of the company's autologous CAR-T therapies.
Last December, the Shanghai-based company revealed the hold on three CAR-T candidates: zevor-cel (CT053), an autologous CAR-T product against BCMA; satri-cel (CT041) an autologous CAR-T product against Claudin18.2; and CT071, an autologous CAR-T product against GPRC5D. According to CARsgen, the holds were placed "pending resolution of the findings following an inspection of the manufacturing site located in Durham, North Carolina."
CARsgen pumped $157 million into the Durham plant — its first manufacturing hub in North America — back in 2021. The company did not reveal details on FDA inspection findings in December, only that they were CMC related.
CT053 was approved in China back in February for the treatment of adult patients with relapsed or refractory multiple myeloma who have previously progressed after at least three lines of therapy. It is currently in phase 1b/2 trials in the U.S. and Canada.
CT041 targets Claudin18.2, a stomach-specific isoform of CLDN18 and is highly expressed in gastric and pancreatic cancer cells. It is currently in phase 1b/2 trials in the U.S. and Canada in patients with advanced gastric, pancreatic or other specified digestive system cancers. CARsgen inked a collaboration with Moderna back in 2021 to evaluate CT041 in combination with Moderna’s investigational Claudin18.2 mRNA cancer vaccine.
CT071, which was developed utilizing CARsgen's proprietary CARcelerate platform, targets GPRC5D, a protein expressed in bone marrow plasma cells and myeloma cell lines. It is currently in phase 1/2 trials in participants with relapsed/refractory multiple myeloma or relapsed/refractory primary plasma cell leukemia.