FDA lifts clinical hold on Allogene Therapeutics trials
The U.S. FDA has removed the clinical hold on Allogene Therapeutics trials following an investigation into a chromosomal abnormality. Findings confirmed the issue was unrelated to Cellectis’ gene-editing platform.
The U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on all five of Allogene Therapeutics’ clinical trials as of January 10, 2022. The regulatory agency had halted the trials in October 2021 following the detection of a chromosomal abnormality in a single patient receiving ALLO-501A therapy.
Allogene conducted an extensive investigation, concluding that the anomaly was not caused by Cellectis’ TALEN gene-editing technology or the manufacturing process. The findings confirmed that the abnormality was absent in other manufactured product lots and other treated patients, deeming it to have no clinical significance.
With the hold lifted, Allogene aims to initiate a Phase 2 pivotal clinical trial for ALLO-501A in patients with relapsed or refractory large B-cell lymphoma. The company expects to begin this study by mid-2022, pending further discussions with the FDA.