Clinical Holds Lifted on 3 CARsgen Cell Products

FDA has lifted a clinical hold on three CARsgen Therapeutics clinical trials evaluating CT053, CT041, and CT071. The holds were placed 12/2023 due to chemistry, manufacturing and controls questions related to findings from an inspection of the company’s manufacturing site located in Durham, NC, according to the company.

CT041 is described as an autologous CAR T-cell product candidate against the protein Claudin18.2, and it targets the treatment of Claudin18.2 positive solid tumors with a primary focus on gastric/gastroesophageal junction cancer and pancreatic cancer. CT053 is an autologous BCMA CAR T-cell product candidate for treating refractory or relapsed multiple myeloma, according to the company. And, it says, CT071 is an autologous CAR T-cell therapy candidate targeting G protein-coupled receptor Class C group 5 member D for treating relapsed/refractory multiple myeloma or relapsed/refractory primary plasma cell leukemia.