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

NCT ID: NCT03902184

Last Updated: 2024-11-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-22
• Study Completion Date: 2026-01-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1: Relapsed/refractory Sezary Syndrome

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.

Group Type: EXPERIMENTAL

IPH4102

Intervention Type: BIOLOGICAL

Patients will receive a flat dose of 750mg

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

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.

Group Type: EXPERIMENTAL

IPH4102

Intervention Type: BIOLOGICAL

Patients will receive a flat dose of 750mg

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

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.

Group Type: EXPERIMENTAL

IPH4102

Intervention Type: BIOLOGICAL

Patients will receive a flat dose of 750mg

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

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.

Group Type: EXPERIMENTAL

IPH4102

Intervention Type: BIOLOGICAL

Patients will receive a flat dose of 750mg

Interventions

IPH4102

Patients will receive a flat dose of 750mg

Intervention Type: BIOLOGICAL

Other Intervention Names

lacutamab

Eligibility Criteria

Inclusion Criteria

SS patients (Cohort 1):

1. Relapsed and/or refractory stage IVA, IVB SS who have received at least two prior systemic therapies;

2. Prior treatment with mogamulizumab;

3. Patients should have blood stage B2 at screening based on central evaluation by flow cytometry;

4. Feasibility of obtaining at least one skin biopsy at screening;

MF patients (Cohorts 2 and All comers):

5. Relapsed and/or refractory stage IB, IIA, IIB, III, IV MF;

6. Only for Cohort 2: KIR3DL2 expression in at least one expressing skin lesion based on central evaluation by IHC;

7. Patients should have received at least two prior systemic therapies;

8. Feasibility of obtaining at least one skin biopsy at screening;

9. Male or Female, at least 18 years of age;

10. ECOG performance status ≤2;

11. 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;

12. Patients should have recovered from all non-hematological adverse events related to prior therapy to ≤ grade 1 except for alopecia;

13. Adequate baseline laboratory data:

Hematology:

• Hemoglobin >9 g/dL,
• Absolute neutrophil count (ANC) ≥1,500/µL,
• Platelets ≥100,000/µL,

Biochemistry:

• Bilirubin ≤1.5 X upper limit of normal (ULN) or ≤3 X ULN for patients with Gilbert's disease,
• Serum creatinine ≤1.5 X ULN,
• Creatinine clearance ≥30 mL/min, calculated with the Cockcroft & Gault formula,
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5 X ULN;

14. Women of childbearing potential (WOCBP): Premenopausal females who had at least one menstrual cycle in the past 12 months and capable to become pregnant. They must have a negative serum beta-HCG pregnancy test result within seven days from start of treatment;

15. Women of childbearing potential and all men (and their female partners of childbearing potential) who are sexually active must agree to use adequate method of contraception at study entry, during treatment and for at least 9 months (270 days) following the last dose of study drug;

16. Signed informed consent form prior to any protocol-specific procedures

Exclusion Criteria

1. Patients with evidence of large cell transformation (LCT) based on central histologic evaluation at screening;

2. Receipt of live vaccines within 4 weeks prior to treatment;

3. Central nervous system (CNS) lymphoma involvement;

4. Prior administration of IPH4102;

5. Concurrent enrollment in another clinical trial, unless it is an observational (non - interventional) clinical study or the follow-up period of an interventional study;

6. Autologous stem cell transplantation less than 3 months prior to enrollment;

7. Prior allogenic transplantation;

8. Patients who have undergone major surgery ≤ 4 weeks prior to study entry;

9. Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection;

10. 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;

11. Known or tested positive for human immunodeficiency virus (HIV);

12. 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

13. Pregnant or breastfeeding women;

14. Known clinically significant cardiovascular disease or condition, including:

• Class III or IV cardiovascular disease according to the New York Heart Association (NYHA) Functional Classification;
• Any uncontrolled arrhythmia (per the investigator's discretion);
• Uncontrolled hypertension (per the investigator's discretion).

15. Patients with autoimmune disease on systemic immunosuppressive treatment;

16. Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment and/or comply with study protocol;

17. Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innate Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

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

Los Angeles, California, United States

Irvine Medical Center

Orange, California, United States

Stanford University

Stanford, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

University of South Florida

Tampa, Florida, United States

Northwestern University The Feinberg School of Medicine

Chicago, Illinois, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Universal Dermatology, PLLC68

Fairport, New York, United States

Columbia University Department of Dermatology

New York, New York, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

University of Pittsburgh School of Medicine

Pittsburgh, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

Inova Health Care Services

Fairfax, Virginia, United States

Universitätsklinik für Dermatologie Medizinische Universität Graz

Graz, , Austria

Medizinische Universitaet Wien

Vienna, , Austria

Institut Jules Bordet

Brussels, , Belgium

UZ Leuven - campus Gasthuisberg

Leuven, , Belgium

Centre Hospitalier Universitaire (CHU) de Liege

Liège, , Belgium

CHU de Bordeaux Saint André

Bordeaux, , France

CHRU de Tours, Hôpital Trousseau

Chambray-lès-Tours, , France

CHU Henri Mondor

Créteil, , France

CHRU de Lille - Hopital Claude Huriez

Lille, , France

Centre Hospitalier Lyon-Sud

Lyon, , France

Institut Paoli-Calmettes

Marseille, , France

CHRU de Montpellier - Hopital Saint Eloi

Montpellier, , France

Hôpital Saint-Louis

Paris, , France

Hôpital Charles Nicolle-CHU de Rouen Clinique Dermatologie

Rouen, , France

IUCT Oncopôle

Toulouse, , France

Charite - Universitaetsmedizin Berlin

Berlin, , Germany

Ruhr-University Bochum

Bochum, , Germany

Universitätsklinikum Frankfurt

Frankfurt, , Germany

Universitaetsklinikum Halle (Saale)

Halle, , Germany

Universitaetsklinikum Schleswig-Holstein Campus Kiel

Kiel, , Germany

Universitaetsmedizin Mannheim GmbH

Mannheim, , Germany

Johannes Wesling Klinikum Minden

Minden, , Germany

Universitaetsklinikum Muenster

Münster, , Germany

Institute of Hematology "Seràgnoli", Univeristy of Bologna

Bologna, , Italy

ASST degli Spedali Civili di Brescia

Brescia, , Italy

Istituto Dermopatico dell'Immacolata (IDI-IRCCS)

Roma, , Italy

Universita di Torino, Ospedale le Molinette

Turin, , Italy

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

Gdansk, , Poland

CET Centrum Medyczne Pratia Poznan ul. Poznanska 14

Skorzewo, , Poland

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

Warsaw, , Poland

Hospital del Mar

Barcelona, , Spain

Hospital Clinic Barcelona

Barcelona, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Hospital Clinico Universitario de Salamanca

Salamanca, , Spain

Consorci Hospital General Universitari de Valencia Servicio de Dermatología

Valencia, , Spain

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Countries

United States; Austria; Belgium; France; Germany; Italy; Poland; Spain

Other Identifiers

2018-003969-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-507777-18-00

Identifier Type: CTIS

Identifier Source: secondary_id

IPH4102-201

Identifier Type: -

Identifier Source: org_study_id