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    Summary
    EudraCT Number:2020-003735-16
    Sponsor's Protocol Code Number:KILT
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-06-08
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2020-003735-16
    A.3Full title of the trial
    A RANDOMIZED NON COMPARATIVE PHASE II STUDY OF LACUTAMAB WITH GEMOX VERSUS GEMOX ALONE IN RELAPSED/REFRACTORY PATIENTS WITH PERIPHERAL T-CELL LYMPHOMA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A STUDY OF LACUTAMAB WITH GEMOX VERSUS GEMOX ALONE IN RELAPSED/REFRACTORY PATIENTS WITH PERIPHERAL T-CELL LYMPHOMA
    A.3.2Name or abbreviated title of the trial where available
    KILT
    A.4.1Sponsor's protocol code numberKILT
    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 SponsorLYSARC
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInnate Pharma
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLYSARC
    B.5.2Functional name of contact pointProject management
    B.5.3 Address:
    B.5.3.1Street AddressCH Lyon Sud
    B.5.3.2Town/ cityPierre Bénite
    B.5.3.3Post code69495
    B.5.3.4CountryFrance
    B.5.6E-mailkilt@lysarc.org
    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 No
    D.2.5.1Orphan drug designation number
    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.3.8INN - Proposed INNLACUTAMAB
    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 No
    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
    Relapsed/refractory PTCL KIR3DL2-positive patients after at least one previous line of systemic based regimen of chemotherapy
    E.1.1.1Medical condition in easily understood language
    Relapsed/refractory patients with peripheral T-cell lymphoma
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10042980
    E.1.2Term T-cell lymphoma refractory
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level PT
    E.1.2Classification code 10042979
    E.1.2Term T-cell lymphoma recurrent
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 median modified progression-free survival (mPFS) of Lacutamab in patients treated with Gemcitabine-oxaliplatin (GemOx) at relapse followed by a Lacutamab maintenance, in relapsed/refractory (R/R) patients with KIR3DL2 positive PTCL-NOS, PTCL-T Follicular Helper (TFH) (including AITL, Follicular T-cell lymphoma, Nodal peripheral T-cell lymphoma with TFH phenotype), ALCL, ATL, HSTL, enteropathy-associated Tcell lymphoma (EATL), monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), NK T-cell lymphoma (NKT) and aggressive NK-cell leukemia (ANKL).
    E.2.2Secondary objectives of the trial
    - To characterize the safety and tolerability of Lacutamab (on both arms)
    - To evaluate overall survival (OS)
    - To evaluated mPFS with PD and relapse evaluated according to Lugano 2014 criteria (PET-based)
    - To evaluate other clinical activity endpoints:
    1. complete response (CR) rate and overall response rate (ORR) according to Lugano 2014 criteria (CTscan)
    2. CR rate and ORR according to Lugano 2014 criteria (PET scan) during induction
    3. response rate assessed by Deauville criteria
    4. duration of response (DOR), calculated as time from first CR or PR according to Lugano 2014 criteria (CT-based) until one of the following events occurs, whichever comes first:
    -To characterize the Pharmacokinetics of lacutamab with GemOx (for experimental arm only)
    - To evaluate the immunogenicity (Anti-Drug Antibodies (ADA)) of lacutamab with GemOx (for experimental
    arm only)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. KIR3DL2-positive with at least 1% of tumour cells positivity, before
    randomization, based on central evaluation by IHC
    2. Patients with histologically documented PTCL:
    o Biopsy-proven treated PTCL defined by the WHO 2016 criteria (the
    biopsy at relapse is recommended but not mandatory):
    ▪ PTCL-NOS
    ▪ PTCL-TFH (AITL, Follicular T-cell lymphoma, Nodal peripheral T-cell
    lymphoma with TFH phenotype)
    ▪ ALCL
    ▪ ATL: acute- or lymphoma-type
    ▪ HSTL
    ▪ EATL
    ▪ MEITL
    ▪ NKT
    ▪ ANKL
    3. For patients with ALCL: previously treated with brentuximab vedotin
    4. Relapsed/refractory PTCL after at least one previous line of systemic
    based regimen of chemotherapy (no mandatory latency after the
    previous treatment)
    5. With a maximum of 2 prior lines of systemic therapies, including
    autologous stem cell transplantation (ASCT is authorized in first and
    second line and is not comptabilized as a unique line, even if associated
    to a systemic therapy)
    6. Bi-dimensionally measurable disease defined by at least one single
    node or tumor lesion ≥ 1.5 cm assessed by CT scan
    7. Signed written screening informed consent prior to KIR3DL2
    screening
    8. Signed written study informed consent prior to randomization
    9. Aged 18 years or more with no upper age limit, at randomization
    10. ECOG performance status 0 to 3 prior to prephase treatment (if
    applicable), and 0 to 2 prior randomization
    11. Minimum life expectancy of 3 months
    12. Females of childbearing potential (FCBP) must agree to use highly
    effective contraceptive method* from C1D1, during the entire study
    period, during dose interruptions, and for 9 months after the last study
    treatments
    13. FCBP must have a negative serum or urinary pregnancy test within 28 days and then within 2 days prior C1D1
    14. Male patients and their partner (FCBP) must agree to use two
    reliable forms of contraception (condom for males and hormonal
    E.4Principal exclusion criteria
    1. Patients with active COVID-19 infection (last positive PCR < 2 weeks before randomization)
    2. Patients taking immunotherapy or chemotherapy, except short-term corticosteroids in monotherapy at a cumulated dose equivalent of prednisone ≤ 1mg/kg/day, during 7 consecutive days, within 3 weeks prior to first administration of study drug (C1D1); or prephase treatment given at investigator's discretion before randomization and for maximum 3 weeks (glucocorticosteroids, vepeside (VP16), cyclophosphamide, vincristine and prednisone (COP))
    3. Previous treatment by Gemcitabine or Oxaliplatin
    4. Use of any experimental anti-cancer drug therapy within 6 weeks before randomization

    5. Contraindication to any drug contained in the study treatment regimen
    6. Previous allogenic hematopoietic cell transplantation
    7. Positive test results for HIV and HCV (Patients who are positive for HCV antibody must be negative for HCV by PCR to be eligible for study participation)
    8. Known active hepatitis B (positive Ag HBs) (if latent HBV (positive anti-HBc), patients have to be treated with Entecavir (Baraclude ®) and HBV PCR should be performed every month to allow antiviral strategy adaptation)
    9. Central nervous system or meningeal involvement by lymphoma
    10. Any of the following laboratory abnormalities prior randomization:
    o Absolute neutrophil count (ANC) < 1 G/L, unless neutropenia is related
    to PTCL
    o Platelet count < 75 G/L, unless thrombopenia is related to PTCL
    o Alkaline Phosphatases > 2.5 x upper limit of normal (ULN)
    o Serum SGOT/AST or SGPT/ALT > 2.5 x ULN
    o Bilirubin > 1.5 x ULN, unless SGOT/AST and SGPT/ALT > 2.5 x ULN or
    bilirubin elevated due to PTCL or hemolysis
    o Calculated creatinine clearance (MDRD or Cockroft) < 40 mL/min
    11. Any significant cardiovascular impairment: New York Heart
    Association (NYHA) Class III or IV cardiac disease, uncontrolled high
    blood pressure, unstable angina, myocardial infarction or stroke within
    the last 6 months from randomization, and cardiac arrhythmia within the
    last 3 months from randomization
    12. Uncontrolled clinically significant intercurrent illness including, but
    not limited to, diabetes, ongoing active infections. Patients receiving
    antibiotics for infections that are under control may be included in the
    study
    13. Concurrent malignancy or prior history of malignancies other than
    lymphoma unless the subject has been free of disease for ≥ 2 years,
    except early stage cutaneous squamous or basal cell carcinoma,
    localized prostate cancer, or cervical intraepithelial neoplasia
    14. Major surgery within 4 weeks before randomization
    15. Pregnant or lactating females
    16. Person deprived of his/her liberty by a judicial or administrative
    decision
    17. Person hospitalized without consent
    18. Adult person under legal protection
    19. Adult person unabled to provide informed consent because of
    intellectual impairment, any serious medical condition, laboratory
    abnormality or psychiatric illness
    20.Extensive radiotherapy (e.g. full pelvis or half spine) within 3 months prior to randomization
    E.5 End points
    E.5.1Primary end point(s)
    median modified progression-free survival (mPFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    6.5 months after the randomization of the last patient or at the latest when median modified PFS has been reached in the experimental arm.
    E.5.2Secondary end point(s)
    - safety and tolerability of Lacutamab
    - overall survival (OS)
    - mPFS to Lugano 2014 criteria (PET-based)
    - complete response (CR) rate
    - overall response rate (ORR) according to Lugano 2014 criteria (CTscan)
    - CR rate and ORR according to Lugano 2014 criteria (PET scan) during induction
    - response rate assessed by Deauville criteria
    - duration of response (DOR)
    - Pharmacokinetics of lacutamab with GemOx
    - immunogenicity (Anti-Drug Antibodies (ADA)) of lacutamab with GemOx
    E.5.2.1Timepoint(s) of evaluation of this end point
    - safety and tolerability of Lacutamab = 28 days after the end of treatment
    - overall survival (OS) = end of study
    - mPFS to Lugano 2014 criteria (PET-based) = 6.5 months after the randomization of the last patient
    - complete response (CR) rate = 3 cycles and end of induction
    - overall response rate (ORR) = 3 cycles and end of induction
    - response rate assessed = 3 cycles and end of induction
    - duration of response (DOR) = end of study
    - Pharmacokinetics and immunogenicity lacutamab with GemOx : C1, C2, C3, C7, C9, C15, end of treatment, M3
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    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 Yes
    E.8.1.1Randomised Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA64
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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
    The end of study will occur when the last patient has been followed-up for survival for at least 6 months after his End of treatment/observation evaluation, has died, has withdrawn his consent, or is lost to follow up (whatever the event that occurs first) or sponsor decision
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 31
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 56
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Subjects will be followed according to the standard of care in the center.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation LYSA
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-14
    P. End of Trial
    P.End of Trial StatusOngoing
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