FDA lifts clinical holds on CARsgen’s CAR T-cell therapy trials

The FDA has lifted clinical holds on three CAR T-cell therapy trials conducted by CARsgen Therapeutics, the company announced today. 

The affected trials include CT053, a CAR T-cell therapy targeting BCMA for refractory or relapsed multiple myeloma; CT041, which targets Claudin18.2 for treating solid tumors like gastric/gastroesophageal junction cancer and pancreatic cancer; and CT071, aimed at GPRC5D for relapsed or refractory multiple myeloma and primary plasma cell leukemia.

The holds were placed due to concerns related to chemistry, manufacturing, and controls (CMC) following an inspection of the company’s manufacturing facility in Durham, North Carolina last December. 

Now, the trials are set to resume in the United States.