After the inspection, the facility is working to improve quality control practices, according to a Dec. 12 news release.
CAR-T drugs, or chimeric antigen receptor T cell therapies, target cancer cells. The federal agency is currently investigating a potential link between the risk of lymphoma and BCMA-directed and CD19-directed CAR-T cell therapies.
The three CARsgen drugs on a clinical hold are “CT041,” a candidate focusing on the protein Claudin18.2 that targets gastric and gastroesophageal junction cancer and pancreatic cancer; “CT053,” a BCMA candidate for treating refractory and/or relapsed multiple myeloma; and “CT071,” which targets GPRC5D for the treatment of relapsed/refractory multiple myeloma or relapsed/refractory primary plasma cell leukemia.
