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.

Purpose

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.

Website: https://clinicaltrials.gov/ct2/show/NCT03902184

Contacts and Locations

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Please refer to this study by its ClinicalTrials.gov identifier: NCT03902184

Study Sponsor

Innate Pharma SA

117, avenue de Luminy

BP 30191

13276 Marseille Cedex 09

FRANCE

Study Director:  

Dr. Hatem A. AZIM, MD, PhD

Senior Medical Director

Phone: +33 (0)4.30.30.30.30

Website: www.innate-pharma.fr