Lacutamab - TELLOMAK Study

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. 


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

Recruiting

Participating Locations:

University of Pittsburgh School of Medicine
Pittsburgh, PA, United States
Principal Investigator
Oleg Akilov, MD
Recruiting
Centre Hospitalier Lyon-Sud
Lyon, France
Principal Investigator
Stephane Dalle, Pr
Recruiting
CHRU de Lille - Hopital Claude Huriez
Lille, France
Principal Investigator
Laurent Mortier, MD
Recruiting
Universitaetsklinikum Halle (Saale)
Halle, Germany
Principal Investigator
Rose Moritz, MD
Recruiting
Washington University School of Medicine
St. Louis, MO, United States
Principal Investigator
Neha Mehta-Shah, MD
Recruiting
Hospital Clinic Barcelona
Barcelona, Spain
Principal Investigator
Andrea Combalia-Escudero, MD
Recruiting
University of Alabama at Birmingham
Birmingham, AL, United States
Principal Investigator
Amitkumar Mehta, MD
Recruiting
Hôpital Charles Nicolle-CHU de Rouen Clinique Dermatologie
Rouen, France
Principal Investigator
Anne-Bénédicte Duvla-Modeste
Recruiting
Dana Farber Cancer Institute
Boston, MA, United States
Principal Investigator
Eric Jacobsen, MD
Recruiting
Dermatology, Ruhr-University Bochum
Bochum, Germany
Principal Investigator
René Stranzenbach, MD
Recruiting
University of California Los Angeles Medical Center
Los Angeles, CA, United States
Principal Investigator
Herbert Eradat, MD
Recruiting
Istituto Dermopatico dell'Immacolata (IDI-IRCCS)
Roma, Italy
Principal Investigator
Alessendro Monopoli, MD
Recruiting
University of South Florida
Tampa, FL, United States
Recruiting
Stanford Cancer Institute
Stanford, CA, United States
Principal Investigator
Youn H Kim, MD
Recruiting
Institut Claudius Regaud Département de Dermatologie
Toulouse, France
Principal Investigator
Serge Boulinguez, MD
Recruiting
CHRU de Tours, Hôpital Trousseau, service Dermatologie
Tours, France
Contact
Laurent Machet
Recruiting
Hôpital Saint-Louis Service de Dermatologie
Paris, France
Principal Investigator
Martine Bagot, Pr
Recruiting
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Principal Investigator
Rafael Botella Estrada, MD
Recruiting
Thomas Jefferson University Hospitals
Philadelphia, PA, United States
Principal Investigator
Pierluigi Porcu, MD
Recruiting
University Hospital Schleswig-Holstein, Campus Kiel
Kiel, Germany
Principal Investigator
Ulrike Wehkamp, MD
Recruiting
Inova Health Care Services
Fairfax, VA, United States
Principal Investigator
Jennifer DeSimone MD
Recruiting
Dartmouth-Hitchcock Medical Center, Lebanon
Lebanon, NH, United States
Principal Investigator
Frederick Lansigan, MD
Recruiting
Istituto di Ematologia Lorenzo e Ariosto Seragnoli
Bologna, Italy
Principal Investigator
Pier Luigi Zinzani, MD
Recruiting
Universal Dermatology
Fairport, NY, United States
Principal Investigator
Brian Poligone, MD
Recruiting
Johannes Wesling Klinikum Minden
Minden, Germany
Principal Investigator
Rudolf Stadler, MD
Recruiting
University of Pennsylvania
Philadelphia, PA, United States
Principal Investigator
Ellen J Kim, MD
Recruiting
Institut Paoli-Calmettes
Marseille, France
Principal Investigator
Jean Marc Schiano de Colella
Recruiting
UT MD Anderson Cancer Center
Houston, TX, United States
Principal Investigator
Auris Huen, MD
Recruiting
CHRU de Montpellier - Hopital Saint Eloi
Montpellier, France
Principal Investigator
Olivier Dereure, MD
Recruiting
CHU de Bordeaux Saint André
Bordeaux, France
Principal Investigator
Marie Beylot-Barry, Pr
Recruiting
Spedali Civili di Brescia
Brescia, Italy
Principal Investigator
Alessendra Tucci, MD
Recruiting
CHU Henri Mondo
Créteil, France
Principal Investigator
Saskia Oro, MD
Recruiting
Universita di Torino
Turin, Italy
Principal Investigator
Paolo Fava, MD
Recruiting
Columbia University Irving Medical Center
New York, NY, United States
Principal Investigator
Larisa Geskin, MD
Recruiting
Hospital Universitario 12 de Octubre
Madrid, Spain
Principal Investigator
Pablo Ortiz-Romero, Pr
Recruiting