IPH4102/Lacutamab Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma

NCT03902184 | Completed Phase 2 DMC FDA Drug

• 3 other identifiers: IPH4102-2012023-507777-18-002018-003969-33
• Study Type: interventional
• Target: 170
• Locations: 8 countries
• Sites: 53

Brief Summary

This is an open label, multi-cohort, and multi-center phase II study, which evaluates the clinical activity and safety of IPH4102 in Sezary Syndrome and Mycosis fungoides as single agent.

Conditions

Lymphoma, T-Cell; Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides/Sezary Syndrome

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Using the Olsen (2011, JCO) criteria (All cohorts)

  From the first dose until study completion, an expected average of 2 years

Secondary Outcomes (10)

• Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) (All cohorts)

  From first dose until study completion, an expected average of 2 years

• Quality of life (QoL) (All cohorts)

  Through study completion, an expected average of 2 years

• pruritus (All cohorts)

  Through study completion, an expected average of 2 years

• ORR using blinded central review (Cohort 1)

  From the first dose until study completion, an expected average of 2 years

• Progression free survival (PFS) (All cohorts)

  From the first dose until study completion, an expected average of 2 years

Study Arms (4)

Cohort 1: Relapsed/refractory Sezary Syndrome

EXPERIMENTAL

IPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.

Biological: IPH4102

Cohort 2: Stage IB-IV Mycosis Fungoides, KIR3DL2 expressing

EXPERIMENTAL

IPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.

Biological: IPH4102

Cohort 3: Stage IB-IV Mycosis Fungoides,KIR3DL2 non-expressing (closed)

EXPERIMENTAL

IPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.

Biological: IPH4102

Cohort All comers: Stage IB-IV Mycosis Fungoides,KIR3DL2 expressing and non-expressing

EXPERIMENTAL

IPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.

Biological: IPH4102

Interventions

IPH4102 BIOLOGICAL

Patients will receive a flat dose of 750mg

Also known as: lacutamab

Cohort 1: Relapsed/refractory Sezary Syndrome; Cohort 2: Stage IB-IV Mycosis Fungoides, KIR3DL2 expressing; Cohort 3: Stage IB-IV Mycosis Fungoides,KIR3DL2 non-expressing (closed); Cohort All comers: Stage IB-IV Mycosis Fungoides,KIR3DL2 expressing and non-expressing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• SS patients (Cohort 1):
• Relapsed and/or refractory stage IVA, IVB SS who have received at least two prior systemic therapies;
• Prior treatment with mogamulizumab;
• Patients should have blood stage B2 at screening based on central evaluation by flow cytometry;
• Feasibility of obtaining at least one skin biopsy at screening;
• MF patients (Cohorts 2 and All comers):
• Relapsed and/or refractory stage IB, IIA, IIB, III, IV MF;
• Only for Cohort 2: KIR3DL2 expression in at least one expressing skin lesion based on central evaluation by IHC;
• Patients should have received at least two prior systemic therapies;
• Feasibility of obtaining at least one skin biopsy at screening;
• Male or Female, at least 18 years of age;
• ECOG performance status ≤2;
• The patient must have a minimum wash-out period of 3 weeks between the last dose of prior systemic therapy and the first dose of IPH4102;
• Patients should have recovered from all non-hematological adverse events related to prior therapy to ≤ grade 1 except for alopecia;
• Adequate baseline laboratory data:

You may not qualify if:

• Patients with evidence of large cell transformation (LCT) based on central histologic evaluation at screening;
• Receipt of live vaccines within 4 weeks prior to treatment;
• Central nervous system (CNS) lymphoma involvement;
• Prior administration of IPH4102;
• Concurrent enrollment in another clinical trial, unless it is an observational (non - interventional) clinical study or the follow-up period of an interventional study;
• Autologous stem cell transplantation less than 3 months prior to enrollment;
• Prior allogenic transplantation;
• Patients who have undergone major surgery ≤ 4 weeks prior to study entry;
• Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection;
• Patients who have Hepatitis B Virus infection determined as HBsAg positive and / or Hepatitis C Virus infection determined as detection of HCV RNA in serum or plasma by a sensitive quantitative molecular method;
• Known or tested positive for human immunodeficiency virus (HIV);
• Patients with a history of other malignancies during the past five years apart from the disease subject of this study. The following are exempt from the five-year limit: non-melanoma skin cancer, lymphomatoid papulosis, resected thyroid cancer, biopsy-proven cervical intraepithelial neoplasia, Ductal carcinoma in situ (DCIS) or cervical carcinoma in situ
• Pregnant or breastfeeding women;
• Known clinically significant cardiovascular disease or condition, including:
• Class III or IV cardiovascular disease according to the New York Heart Association (NYHA) Functional Classification;

Sponsors & Collaborators

• Innate Pharma: lead

Study Sites (53)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California, Los Angeles (UCLA) - Medical Center

Los Angeles, California, 90095, United States

Location

Irvine Medical Center

Orange, California, 92868, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University of South Florida

Tampa, Florida, 33612, United States

Location

Northwestern University The Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Universal Dermatology, PLLC68

Fairport, New York, 14450, United States

Location

Columbia University Department of Dermatology

New York, New York, 10032, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, 15208, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Inova Health Care Services

Fairfax, Virginia, 22031, United States

Location

Universitätsklinik für Dermatologie Medizinische Universität Graz

Graz, A-8036, Austria

Location

Medizinische Universitaet Wien

Vienna, 1090, Austria

Location

Institut Jules Bordet

Brussels, 1070, Belgium

Location

UZ Leuven - campus Gasthuisberg

Leuven, 3000, Belgium

Location

Centre Hospitalier Universitaire (CHU) de Liege

Liège, 4000, Belgium

Location

CHU de Bordeaux Saint André

Bordeaux, 33075, France

Location

CHRU de Tours, Hôpital Trousseau

Chambray-lès-Tours, 37170, France

Location

CHU Henri Mondor

Créteil, 94010, France

Location

CHRU de Lille - Hopital Claude Huriez

Lille, 59037, France

Location

Centre Hospitalier Lyon-Sud

Lyon, 69310, France

Location

Institut Paoli-Calmettes

Marseille, 13009, France

Location

CHRU de Montpellier - Hopital Saint Eloi

Montpellier, 34095, France

Location

Hôpital Saint-Louis

Paris, 75010, France

Location

Hôpital Charles Nicolle-CHU de Rouen Clinique Dermatologie

Rouen, 76031, France

Location

IUCT Oncopôle

Toulouse, 31100, France

Location

Charite - Universitaetsmedizin Berlin

Berlin, 10115, Germany

Location

Ruhr-University Bochum

Bochum, 44791, Germany

Location

Universitätsklinikum Frankfurt

Frankfurt, 60590, Germany

Location

Universitaetsklinikum Halle (Saale)

Halle, 06120, Germany

Location

Universitaetsklinikum Schleswig-Holstein Campus Kiel

Kiel, 24105, Germany

Location

Universitaetsmedizin Mannheim GmbH

Mannheim, 68167, Germany

Location

Johannes Wesling Klinikum Minden

Minden, 32429, Germany

Location

Universitaetsklinikum Muenster

Münster, 48149, Germany

Location

Institute of Hematology "Seràgnoli", Univeristy of Bologna

Bologna, 40138, Italy

Location

ASST degli Spedali Civili di Brescia

Brescia, 25123, Italy

Location

Istituto Dermopatico dell'Immacolata (IDI-IRCCS)

Roma, 00167, Italy

Location

Universita di Torino, Ospedale le Molinette

Turin, 10126, Italy

Location

Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii ul. Smoluchowskiego 17

Gdansk, 80-214, Poland

Location

CET Centrum Medyczne Pratia Poznan ul. Poznanska 14

Skorzewo, 60-185, Poland

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Ukladu Chlonnego

Warsaw, 02-781, Poland

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital Clinic Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Clinico Universitario de Salamanca

Salamanca, 37007, Spain

Location

Consorci Hospital General Universitari de Valencia Servicio de Dermatología

Valencia, 46014, Spain

Location

Hospital Universitari i Politecnic La Fe

Valencia, 46026, Spain

Location

MeSH Terms

Conditions

Lymphoma, T-Cell; Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides; Sezary Syndrome

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2019
• First Posted: April 3, 2019
• Study Start: May 22, 2019
• Primary Completion: January 8, 2026
• Study Completion: January 8, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (6); US (17); IT (4); AU (2); PL (3); DE (8); BE (3); FR (10)