FDA places Innate Pharma lacutamab study on partial clinical hold

Enrollment has been suspended in a Phase 2 clinical trial, TELLOMAK, evaluating Innate Pharma SA’s (NASDAQ:IPHA) lacutamab (IPH4102) in patients with advanced T-cell lymphomas. The company says it took action after the FDA placed the study on partial clinical hold due to deficiencies at a subcontractor responsible for fill and finish operations.

It is in the process of transferring the fill and finish business to a new contract manufacturing organization. A new GMP-certified batch should be available in H2.

A partial clinical hold suspends enrollment but allows current participants in the study to continue treatment.

https://seekingalpha.com/news/3530620-fda-places-innate-pharma-lacutamab-study-on-partial-clinical-hold