FDA places partial hold on trials for T-cell lymphomas after patient death
Click Here to Manage Email Alerts
The FDA placed a partial clinical hold on two trials evaluating lacutamab for T-cell lymphomas after a patient died of hemophagocytic lymphohistiocytosis, according to the agent’s manufacturer.
Hemophagocytic lymphohistiocytosis is a rare hematologic disorder characterized by severe hyperinflammation that can result in extensive organ damage.
The hold pauses new patient enrollment for the phase 2 TELLOMAK study, evaluating lacutamab (Innate Pharma) — a humanized, anti-KIR3DL2 antibody — for individuals with Sézary syndrome and mycosis fungoides, the two most common forms of advanced cutaneous T-cell lymphoma.
Enrollment also is paused for a phase 1b study designed to assess lacutamab for treatment of relapsed or refractory peripheral T-cell lymphoma.
“Patient safety is of paramount importance to us, and we are currently undertaking efforts to address the FDA requests, which include incorporation of risk mitigation and management strategies for hemophagocytic lymphohistiocytosis in ongoing lacutamab studies,” Mondher Mahjoubi, MD, CEO of Innate Pharma, said in a company-issued press release. “With all patients recruited into the phase 2 TELLOMAK study, we do not currently anticipate any delay for the TELLOMAK phase 2 final data due shortly.”
Patients already receiving treatment in both studies and deriving clinical benefit can continue therapy after reauthorizing their consent, according to the release.
Click Here to Manage Email Alerts