FDA Lifts Partial Clinical Hold on Innate Pharma’s T-Cell Lymphoma Trial

The FDA has lifted a partial clinical hold on Innate Pharma’s phase 2 clinical trial of lacutamab in patients with advanced T-cell lymphomas.

The agency placed the trial on hold in January due to good manufacturing practice (GMP) deficiencies at a manufacturing facility in Austria. It lifted the hold based on a positive assessment of a new GMP-certified batch manufactured for the trial.

Innate said it is now in discussions with regulatory authorities in Germany, Italy and Spain, where the trial was also temporarily halted.