The U.S. Food and Drug Administration has placed Innate Pharma SA's mid-stage Tellomak study for evaluating its blood cancer drug lacutamab on partial clinical hold.
Regulatory authorities found problems with the vials — provided to Innate by its subcontractor — used in the trial, the French biotechnology company said in a Jan. 9 press release.
Lacutamab is aimed at treating advanced T cell lymphoma, a type of cancer that originates in the infection-fighting cells of the immune system.
The FDA ruled that no new patients will be allowed in the trial until it replaces its batch of vials with products that meet Good Manufacturing Practice standards. Innate is allowed to progress the trial with the currently enrolled patients after it obtains their consent to continue with the study.
The U.K.'s Medicines and Healthcare Products Regulatory Agency has not placed the trial on halt. Innate is awaiting the decision of the National Agency for the Safety of Medicines and Health Products in France.
Innate said no safety issues had been connected to lacutamab, also known as IPH4102, which has been well-tolerated so far in the trial.