FDA slaps clinical hold on Legend Biotech CAR-T trials

Feb. 16, 2022

The U.S. FDA has placed a clinical hold on Legend Biotech Corporation’s clinical trial of an investigational CAR-T drug, Legend announced.

The trial involves Legend's LB1901, an investigational CAR-T therapy that targets cancerous CD4+ T-cells in adults with relapsed or refractory T-cell lymphoma. So far, just one patient has been dosed in the clinical trial. Legend is a subsidiary of Genscript Biotech, a leading biology research service company. Both Legend and Genscript are headquartered in New Jersey.

A press release from Legend provided little information about the details of the clinical hold. The FDA notified the company of the hold via email. The agency is expected to provide an official letter to Legend by March 11. 

The stoppage came after the only patient dosed in clinical trials experienced low CD4+ T-cell counts, according to Legend. CD4+ T-cells are a type of white blood cell responsible for coordinating immune responses. The patient has not experienced any drug-related serious adverse events and is currently being monitored, the company said.

LB1901 received FDA clearance for its investigational new drug application in December 2020. The company announced the start of the clinical trials in September.

Legend is not the only company to have bumps in the road with their investigational CAR-T trials. Allogene’s clinical trials of AlloCAR T were placed on hold by the FDA in October 2021, following a report to the FDA of a chromosomal abnormality detected in the bone marrow of a study patient with stage IV lymphoma. The FDA lifted the clinical hold in Jan. after it was determined that the reported chromosomal abnormality was not caused by Allogene’s gene editing or manufacturing process.