The FDA has lifted its partial clinical hold on Adaptimmune’s trial investigating a T-cell therapy for a connective tissue cancer.
The agency placed the hold to better understand the candidate’s manufacturing process and the company’s plans for patient monitoring among other details related to protocol design. The clinical hold did not pose any safety concerns, the company said.
After Adaptimmune provided the agency with additional information, the FDA cleared the company to enroll patients in the trial. The company intends to start the study by recruiting 15 patients.