The U.S. Food & Drug Administration (FDA) has placed a partial clinical hold on the TELLOMAK (NCT03902184) trial which is evaluating the safety and efficacy of lacutamab (IPH4102) in patients with advanced T-cell lymphomas, (TCLs).1 This decision comes after discussions with regulatory authorities about Good Manufacturing Practice (GMP) deficiencies at a subcontractor site which managed the fill and finish operations of the lacutamab vials.
TELLOMAK trial is a phase II, open-label, multi-cohort, multi-center study investigating the safety and clinical activity of lacutamab alone or in combination with chemotherapy. Enrollment of new patients has been suspended until a new GCP-certified batch of lacutamab is available, however, patients currently enrolled on the trial may continue treatment if they re-consent.
Lacutamab is a first-in-class anti-killer cell immunoglobulin-like receptor 3DL2 (KIR3DL2) monoclonal antibody. KIR3DL2 is an inhibitory receptor which is expressed abundantly across cutaneous TCL (CTCL) tumor cells but not normal immune cells. Binding of lacutamab to KIR3DL2 on tumor cells initiates the recruitment of natural killer cells and subsequent immune-mediated depletion of tumor cells.1
Lacutamab has shown promising clinical activity and an acceptable safety profile in a phase I study (NCT02593045) of patients with relapsed/refractory CTCL.2 In August 2014, lacutamab was granted orphan drug status in the European Union and United States for the treatment of CTCL.3 In January 2019, the FDA granted Fast Track designation for lacutamab for the treatment of adults with relapsed or refractory Sézary syndrome (an aggressive form of CTCL).3
For more information on TCL, see the Lymphoma Hub article here.