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

Phase 2

Active, not recruiting

• Conditions: Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Mycosis Fungoides/Sezary Syndrome
• Interventions: Biological: IPH4102

• Registration Number: NCT03902184
• Lead Sponsor: Innate Pharma

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-04-02
• Study First Posted: 2019-04-03
• Study Start: 2019-05-22
• Primary Completion: 2023-10-31
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort All comers: Stage IB-IV Mycosis Fungoides,KIR3DL2 expressing and non-expressing	IPH4102	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.
Cohort 3: Stage IB-IV Mycosis Fungoides,KIR3DL2 non-expressing (closed)	IPH4102	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.
Cohort 1: Relapsed/refractory Sezary Syndrome	IPH4102	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.
Cohort 2: Stage IB-IV Mycosis Fungoides, KIR3DL2 expressing	IPH4102	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.

Primary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	From the first dose until study completion, an expected average of 2 years	Using the Olsen (2011, JCO) criteria (All cohorts)

Secondary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) (All cohorts)	From first dose until study completion, an expected average of 2 years	patients with treatment-related adverse events as assessed by CTCAE v5.0
Overall survival (OS) (All cohorts)	From the first dose until study completion, an expected average of 2 years
Immunogenicity of IPH4102 alone (All cohorts)	From the first dose until study completion, an expected average of 2 years	A serum sample will be collected at the specified time points for evaluation of anti-drug antibodies (ADA).
PK parameters : Maximum Plasma Concentration of IPH4102 alone (All cohorts)	From the first dose until study completion, an expected average of 2 years	Maximum Plasma Concentration (Cmax) (W1, W5)
Duration of Response (DOR)	From the 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	Using the Skindex29 questionnaire to assesse the effects of skin disease on quality of life in three domains: Symptoms, Emotions, and Functioning
pruritus (All cohorts)	Through study completion, an expected average of 2 years	Using Visual Analog Scale (VAS) for prutitus assessment: From 0 = No pruritus to 10 = Pruritus as bad as it could possibly be
ORR using blinded central review (Cohort 1)	From the first dose until study completion, an expected average of 2 years	Using the Olsen (2011, JCO) criteria
Progression free survival (PFS) (All cohorts)	From the first dose until study completion, an expected average of 2 years
PK parameters :Trough Concentration of IPH4102 alone (All cohorts)	From the first dose until study completion, an expected average of 2 years	Trough Concentration (Ctrough) every 8 or 12 weeks

Trial Locations

Locations (53)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of California, Los Angeles (UCLA) - Medical Center; 🇺🇸 Los Angeles, California, United States

Inova Health Care Services; 🇺🇸 Fairfax, Virginia, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, 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

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pittsburgh School of Medicine; 🇺🇸 Pittsburgh, Pennsylvania, United States

Irvine Medical Center; 🇺🇸 Orange, California, United States

Stanford University; 🇺🇸 Stanford, California, United States

Universal Dermatology, PLLC68; 🇺🇸 Fairport, New York, United States

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Columbia University Department of Dermatology; 🇺🇸 New York, New York, United States

Universitätsklinik für Dermatologie Medizinische Universität Graz; 🇦🇹 Graz, Austria

CHU Henri Mondor; 🇫🇷 Créteil, France

Centre Hospitalier Universitaire (CHU) de Liege; 🇧🇪 Liège, Belgium

CHU de Bordeaux Saint André; 🇫🇷 Bordeaux, France

Medizinische Universitaet Wien; 🇦🇹 Wien, Austria

Institut Jules Bordet; 🇧🇪 Brussel, Belgium

UZ Leuven - campus Gasthuisberg; 🇧🇪 Leuven, Belgium

CHRU de Tours, Hôpital Trousseau; 🇫🇷 Chambray-lès-Tours, France

Institut Paoli-Calmettes; 🇫🇷 Marseille, France

CHRU de Lille - Hopital Claude Huriez; 🇫🇷 Lille, France

CHRU de Montpellier - Hopital Saint Eloi; 🇫🇷 Montpellier, France

Hôpital Charles Nicolle-CHU de Rouen Clinique Dermatologie; 🇫🇷 Rouen, France

Hôpital Saint-Louis; 🇫🇷 Paris, France

Centre Hospitalier Lyon-Sud; 🇫🇷 Lyon, France

IUCT Oncopôle; 🇫🇷 Toulouse, France

Charite - Universitaetsmedizin Berlin; 🇩🇪 Berlin, Germany

Ruhr-University Bochum; 🇩🇪 Bochum, Germany

Universitätsklinikum Frankfurt; 🇩🇪 Frankfurt, Germany

Johannes Wesling Klinikum Minden; 🇩🇪 Minden, Germany

Universitaetsklinikum Halle (Saale); 🇩🇪 Halle, Germany

ASST degli Spedali Civili di Brescia; 🇮🇹 Brescia, Italy

Universitaetsmedizin Mannheim GmbH; 🇩🇪 Mannheim,, Germany

Universitaetsklinikum Schleswig-Holstein Campus Kiel; 🇩🇪 Kiel, Germany

Universitaetsklinikum Muenster; 🇩🇪 Muenster, Germany

Institute of Hematology "Seràgnoli", Univeristy of Bologna; 🇮🇹 Bologna, Italy

Istituto Dermopatico dell'Immacolata (IDI-IRCCS); 🇮🇹 Roma, Italy

Universita di Torino, Ospedale le Molinette; 🇮🇹 Turin, Italy

CET Centrum Medyczne Pratia Poznan ul. Poznanska 14; 🇵🇱 Skorzewo, Poland

Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii ul. Smoluchowskiego 17; 🇵🇱 Gdańsk, Poland

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Ukladu Chlonnego; 🇵🇱 Warsaw, Poland

Hospital Clinic Barcelona; 🇪🇸 Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital Clinico Universitario de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Universitari i Politecnic La Fe; 🇪🇸 Valencia, Spain

Consorci Hospital General Universitari de Valencia Servicio de Dermatología; 🇪🇸 Valencia, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States