An open label, multi-cohort, multi-center phase II study evaluating the efficacy and safety of lacutamab (IPH4102) alone or in combination with chemotherapy in patients with advanced t-cell lymphoma
Clinical Trial Name: IPH4102-201 / TELLOMAK study
Clinical Trial Description:
The trial is an open label, multi-cohort and multi-center phase II. It is designed to include a total of 3 cohorts, 1 cohort for Sézary syndrome (SS) patients (Cohort 1) and 2 cohorts for mycosis fungoides (MF) patients (Cohorts 2-3). All patients will be treated with lacutamab (IPH4102) in monotherapy. For MF patients (Cohorts 2 and 3), central testing on the protein KIR3DL2 will be performed to inform on cohort allocation.
The purpose of this study is to evaluate the effectiveness and safety of a new experimental drug named lacutamab. Lacutamab is a monoclonal antibody that targets the protein KIR3DL2 and was shown to deplete the cells that express the receptor. Lacutamab was previously administered in a previous clinical study that included 44 patients, of whom 35 had SS and 8 had MF. It was shown to be safe. Preliminary results suggest that it is associated with encouraging clinical activity in patients with SS. Very few MF patients were previously treated with lacutamab to inform on its effectiveness. This study aims to confirm the clinical activity of lacutamab in SS and inform on its potential efficacy and safety in MF.
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT03902184
Innate Pharma SA
117, avenue de Luminy
13276 Marseille Cedex 09
Dr. Hatem A. AZIM, MD, PhD
Senior Medical Director
Phone: +33 (0)126.96.36.199.30