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    Summary
    EudraCT Number:2018-003969-33
    Sponsor's Protocol Code Number:IPH4102-201
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-02-19
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2018-003969-33
    A.3Full title of the trial
    TELLOMAK: T-cell Lymphoma anti-KIR3DL2 therapy. An open label, multi-cohort, multi-center phase II study evaluating the efficacy and safety of IPH4102 alone or in combination with chemotherapy in patients with Advanced T-cell lymphoma.
    TELLOMAK: T-cell Lymphoma anti-KIR3DL2 therapy (Anti-KIR3DL2-Therapie bei T-Zell-Lymphom). Eine unverblindete, multizentrische Phase-II-Studie mit mehreren Kohorten zur Beurteilung der Wirksamtkeit und Sicherheit von IPH4102 allein oder in Kombination mit einer Chemotherapie bei Patienten mit fortgeschrittenem T-Zell-Lymphom
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of IPH4102 alone or in combination with chemotherapy in patients with Advanced T-cell Lymphoma.
    A.4.1Sponsor's protocol code numberIPH4102-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03902184
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInnate Pharma SA
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINNATE PHARMA
    B.5.2Functional name of contact pointMedical Director
    B.5.3 Address:
    B.5.3.1Street Address117, avenue de Luminy - BP30191
    B.5.3.2Town/ cityMarseille Cedex 09
    B.5.3.3Post code13276
    B.5.3.4CountryFrance
    B.5.4Telephone number+330430 30 30 30
    B.5.5Fax number+330430 30 30 10
    B.5.6E-mailinfo@innate-pharma.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
    D.2.5.1Orphan drug designation numberEU/3/14/1322
    D.3 Description of the IMP
    D.3.1Product namelacutamab
    D.3.2Product code IPH4102
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 2187368-16-5
    D.3.9.3Other descriptive nameIPH4102
    D.3.9.4EV Substance CodeSUB176312
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D.3.11.13.1Other medicinal product typeHumanised IgG1 monoclonal antibody
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced T-Cell Lymphomas (TCL), i.e. Cutaneous T Cell Lymphomas (CTCL)
    CTCL subtypes under investigation: relapsed/refractory Sézary Syndrome (SS), stage IB to IV Mycosis Fungoides (MF).
    AngioImmunoblastic T-cell Lymphoma (AITL), Anaplastic Large Cell Lymphoma (ALCL).
    E.1.1.1Medical condition in easily understood language
    Rare types of cancers of the immune system
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10002450
    E.1.2Term Angioimmunoblastic T-cell lymphomas
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10002235
    E.1.2Term Anaplastic large cell lymphomas T- and null-cell types
    E.1.2System Organ Class 100000004851
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10028484
    E.1.2Term Mycoses fungoides
    E.1.2System Organ Class 100000004851
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the clinical activity of IPH4102 (Cohorts 1-3) as a monotherapy in patients with advanced T-cell lymphoma.
    E.2.2Secondary objectives of the trial
    -To evaluate the objective response rate (ORR) of IPH4102 in patients with advanced T-cell lymphoma.
    E.2.3Trial contains a sub-study No
    E.3Principal 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 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;

    - Additional inclusion criteria applicable to all cohorts:
    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.
    E.4Principal 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 the 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 active 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.
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response Rate (ORR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    ORR: until End of treatment (EOT) and during Follow-Up (FU) if applicable as per Protocol.
    E.5.2Secondary end point(s)
    To characterize the safety and tolerability of IPH4102; To assess Quality of life (QoL); To evaluate other clinical activity endpoints: ORR using blinded central review (Cohort 1 only), duration of response (DOR), progression free survival (PFS) and overall survival (OS); To evaluate the pharmacokinetics (PK) and immunogenicity of IPH4102.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Until EOT and during FU if applicable.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA40
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    United States
    Austria
    Belgium
    France
    Germany
    Italy
    Poland
    Spain
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 85
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 85
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    F.4.2.2In the whole clinical trial 170
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-06-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-04
    P. End of Trial
    P.End of Trial StatusOngoing
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