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
FDA places partial hold on trials for T-cell lymphomas after patient death
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