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

Sponsor
Innate Pharma (Industry)
Overall Status
Recruiting
CT.gov ID
NCT03902184
Collaborator
(none)
166
Enrollment
53
Locations
4
Arms
57.3
Anticipated Duration (Months)
3.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: IPH4102
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
166 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
TELLOMAK: T-cell Lymphoma Anti-KIR3DL2 Therapy. An Open Label, Multicohort, Multi-center Phase II Study Evaluating the Efficacy and Safety of IPH4102/Lacutamab Alone or in Combination With Chemotherapy in Patients With Advanced T-cell Lymphoma
Actual Study Start Date :
May 22, 2019
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Biological: IPH4102
Patients will receive a flat dose of 750mg
Other Names:
  • lacutamab

    		•
    Experimental: 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.

    Biological: IPH4102
    Patients will receive a flat dose of 750mg
    Other Names:
  • lacutamab

    		•
    Experimental: 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.

    Biological: IPH4102
    Patients will receive a flat dose of 750mg
    Other Names:
  • lacutamab

    		•
    Experimental: 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.

    Biological: IPH4102
    Patients will receive a flat dose of 750mg
    Other Names:
  • lacutamab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. 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

    4. 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

    5. Progression free survival (PFS) (All cohorts) [From the first dose until study completion, an expected average of 2 years]

    6. Overall survival (OS) (All cohorts) [From the first dose until study completion, an expected average of 2 years]

    7. 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)

    8. 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

    9. 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).

    10. Duration of Response (DOR) [From the first dose until study completion, an expected average of 2 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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):

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

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

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

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

    Additional inclusion criteria applicable to all cohorts:

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

    2. ECOG performance status ≤2;

    3. 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;

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

    5. 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;

    1. 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;

    2. 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;

    3. 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).

    1. Patients with autoimmune disease on systemic immunosuppressive treatment;

    2. 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;

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham Birmingham Alabama United States 35294
    2 University of California, Los Angeles (UCLA) - Medical Center Los Angeles California United States 90095
    3 Irvine Medical Center Orange California United States 92868
    4 Stanford University Stanford California United States 94305
    5 Moffitt Cancer Center Tampa Florida United States 33612
    6 University of South Florida Tampa Florida United States 33612
    7 Northwestern University The Feinberg School of Medicine Chicago Illinois United States 60611
    8 Dana-Farber Cancer Institute Boston Massachusetts United States 02215
    9 Washington University School of Medicine Saint Louis Missouri United States 63110
    10 Dartmouth Hitchcock Medical Center Lebanon New Hampshire United States 03756
    11 Universal Dermatology, PLLC68 Fairport New York United States 14450
    12 Columbia University Pediatric Neuromuscular Center Columbia UMC New York New York United States 10032
    13 University of Pennsylvania Philadelphia Pennsylvania United States 19104
    14 Thomas Jefferson University Philadelphia Pennsylvania United States 19107
    15 University of Pittsburgh School of Medicine Pittsburgh Pennsylvania United States 15208
    16 MD Anderson Cancer Center Houston Texas United States 77030-4009
    17 Inova Health Care Services Fairfax Virginia United States 22031
    18 Universitätsklinik für Dermatologie Medizinische Universität Graz Graz Austria
    19 Medizinische Universitaet Wien Wien Austria 1090
    20 Institut Jules Bordet Brussel Belgium 1000
    21 UZ Leuven - campus Gasthuisberg Leuven Belgium 3000
    22 Centre Hospitalier Universitaire (CHU) de Liege Liège Belgium 4000
    23 CHU de Bordeaux Saint André Bordeaux France 33075
    24 CHRU de Tours, Hôpital Trousseau Chambray-lès-Tours France 37170
    25 CHU Henri Mondor Créteil France 94010
    26 CHRU de Lille - Hopital Claude Huriez Lille France 59037
    27 Centre Hospitalier Lyon-Sud Lyon France 69310
    28 Institut Paoli-Calmettes Marseille France 13009
    29 CHRU de Montpellier - Hopital Saint Eloi Montpellier France 34095
    30 Hôpital Saint-Louis Paris France 75010
    31 Hôpital Charles Nicolle-CHU de Rouen Clinique Dermatologie Rouen France 76031
    32 IUCT Oncopôle Toulouse France 31100
    33 Charite - Universitaetsmedizin Berlin Berlin Germany 10117
    34 Ruhr-University Bochum Bochum Germany
    35 Universitätsklinikum Frankfurt Frankfurt Germany 60590
    36 Universitaetsklinikum Halle (Saale) Halle Germany 06120
    37 Universitaetsklinikum Schleswig-Holstein Campus Kiel Kiel Germany 24105
    38 Universitaetsmedizin Mannheim GmbH Mannheim, Germany 68167
    39 Johannes Wesling Klinikum Minden Minden Germany 32429
    40 Universitaetsklinikum Muenster Muenster Germany 48149
    41 Institute of Hematology "Seràgnoli", Univeristy of Bologna Bologna Italy 40138
    42 ASST degli Spedali Civili di Brescia Brescia Italy 25123
    43 Istituto Dermopatico dell'Immacolata (IDI-IRCCS) Roma Italy 00167
    44 Universita di Torino, Ospedale le Molinette Turin Italy 10126
    45 Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii ul. Smoluchowskiego 17 Gdańsk Poland
    46 CET Centrum Medyczne Pratia Poznan ul. Poznanska 14 Skorzewo Poland
    47 Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Ukladu Chlonnego Warsaw Poland
    48 Hospital del Mar Barcelona Spain 08003
    49 Hospital Clinic Barcelona Barcelona Spain 08036
    50 Hospital Universitario 12 de Octubre Madrid Spain
    51 Hospital Clinico Universitario de Salamanca Salamanca Spain
    52 Consorci Hospital General Universitari de Valencia Servicio de Dermatología Valencia Spain 46014
    53 Hospital Universitari i Politecnic La Fe Valencia Spain 46026

    Sponsors and Collaborators

    • Innate Pharma

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Innate Pharma
    ClinicalTrials.gov Identifier:
    NCT03902184
    Other Study ID Numbers:
    • IPH4102-201
    • 2018-003969-33
    First Posted:
    Apr 3, 2019
    Last Update Posted:
    Jun 22, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Mycoses
    Lymphoma
    Lymphoma, T-Cell
    Lymphoma, T-Cell, Peripheral
    Mycosis Fungoides
    Sezary Syndrome
    Lymphoma, T-Cell, Cutaneous

    Study Results

    No Results Posted as of Jun 22, 2022