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    Summary
    EudraCT Number:2019-000911-10
    Sponsor's Protocol Code Number:PHINK_01_2019
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2020-05-28
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2019-000911-10
    A.3Full title of the trial
    A phase I dose-scalation multicentre study to evaluate the safety of a single infusion of alloreactive or IL-15 ex-vivo activated Natural Killer cells after Haploidentical Stem Cell Transplantation in high risk paediatric patients with haematological malignancies (PHINK).
    Ensayo clínico multicéntrico, prospectivo, no aleatorizado, de fase I, con control histórico para determinar la seguridad y eficacia de una única infusión de células NK aloreactivas/estimuladas ex vivo con IL-15 en el día +7 post haploTPH en pacientes pediátricos con hemopatías malignas de alto riesgo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Infusión of NK cells after Transplantation in paediatric patients with leukaemia
    Infusión de células NK en paciente pediátricos transplantados con leucemia.
    A.4.1Sponsor's protocol code numberPHINK_01_2019
    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 SponsorFundacion de investigacion Biomedica Hospital Universitario la Paz (FIBHULP)
    B.1.3.4CountrySpain
    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 supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUCICEC
    B.5.2Functional name of contact pointIrene Garcia
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana, 261
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28046
    B.5.3.4CountrySpain
    B.5.4Telephone number0034912071466
    B.5.5Fax number0034912071466
    B.5.6E-mailirene.ucicec@gmail.com
    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 nameNK Cells stimulated with IL-15
    D.3.2Product code PF-007
    D.3.4Pharmaceutical form Injection
    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 INNNK cells diferenciated adult allogeneic haploidentical ofexpanded periferic blood and activated with IL
    D.3.9.3Other descriptive nameAllogeneic NK CELLS
    D.3.9.4EV Substance CodeSUB96126
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number50000000
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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 typeNK cells from haploidentical donor
    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
    High risk leukaemia paediatric patients who would receive an haploidentical HSCT to be cured
    Leucemia de alto riesgo en pacientes pediatricos que han recibido un trasplante haploidéntico de progenitores hematopoyéticos
    E.1.1.1Medical condition in easily understood language
    High-risk leukemia in pediatric transplant patients.
    Leucemia de alto riesgo en paciente pediatricos trasplantados.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the safety, tolerability and the dose-limiting toxicities (DLT) of a single infusion of alloreactive or IL-15 ex-vivo activated Natural Killer cell after Haploidentical Stem Cell Transplantation. As co-primary objective we monitorize immune reconstitution including NK cell subsets, and NK cell cytotoxicity during the first year after HSCT.
    Objetivo Principal: Determinar toxicidad limitante de dosis (TLD) y la dosis máxima tolerada (DMT) de una única infusión de células NK aloreactivas o de células NK estimuladas ex vivo con IL-15 tras haploTPH en pacientes pediátricos con leucemias de alto riesgo.
    E.2.2Secondary objectives of the trial
    1. To determine the efficacy of post haploTPH NK cell therapy, comparing it with the historical cohort recently reported by the GETH / GETMON.
    2. Compare the clinical evolution of patients with the historical cohort recently reported by the GETH / GETMON.
    3. Monitor immune reconstitution and characterize NK cells in patients, at the phenotypic and functional level, for 1 year after haploTPH.
    1.Determinar la eficacia de la terapia celular NK post haploTPH, comparándola con la cohorte histórica recientemente reportada por el GETH/GETMON.
    2.Comparar la evolución clínica de los pacientes con la cohorte histórica recientemente reportada por el GETH/GETMON.
    3.Monitorizar la reconstitución inmune y caracterizar las células NK en los pacientes, a nivel fenotípico y funcional, durante 1 año tras haploTPH.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Patients of both genders with age ≤ 21 years.
    2. Not having an identical HLA donor (family or not) available in the time necessary for the donation of hematopoietic parents.
    3. Have disposition of a haploidentical donor.
    4. Diagnosis of high-risk hematologic malignancy. This includes:
    i. High-risk of acute lymphoblastic leukemia in first complete remission (CR1);
    ii. acute lymphoblastic leukemia in second complete remission (CR2);
    iii. acute lymphoblastic leukemia in third complete remission (CR3) or later;
    iv. High risk acute myeloid leukemia in CR1;
    v. acute myeloid leukemia in CR2 or later;
    vi. Relapsed acute myeloid leukemia with <25% in bone marrow blasts;
    vii. acute myeloid leukemia related to previous treatments in CR> 12 months;
    viii Primary or secondary myelodysplastic syndrome;
    ix. NK cell leukemia, biphenotypic or undifferentiated in CR1 or later,
    x. Chronic myeloid leukemia (CML) in accelerated phase, in chronic phase with persistent molecular positivity, or with intolerance to tyrosine kinase inhibitors;
    xi. Hodgkin lymphoma in CR2 or later after autologous TPH failure, or unable to mobilize hematopoietic progenitors for autologous TPH;
    xii. Non-Hodgkin lymphoma in CR2 or later after autologous TPH failure, or unable to mobilize hematopoietic progenitors for autologous TPH;
    xiii. Juvenile myelomonocytic leukemia.

    5. Evaluation prior to positive transplantation:
    I. Left ventricular ejection fraction> 40% or shortening fraction ≥ 25%;
    ii) Creatinine clearance (ACr) or glomerular filtration rate (GFR) ≥ 50 ml / min / 1.73 m2;
    iii) Forced vital capacity (FVC) ≥ 50% of the predicted value or pulse-oximetry ≥ 92% if the patient cannot perform lung function tests;
    iv. Karnofsky or Lansky index (probabilities of the patient's age) ≥ 50;
    v. Bilirubin ≤ 3 times the upper limit of normal for age;
    vi. Alanine aminotransferase (ALT) ≤ 5 times the upper limit of normal for age.
    vii. Women who are not breastfeeding.
    viii No bacterial, fungal or viral infections not controlled at the time of inclusion.

    6. Women with childbearing capacity must have a negative serum or urine pregnancy test performed within 14 days prior to inclusion in the trial and must agree to use highly specific contraceptive methods (diaphragms plus spermicide or male preservative plus spermicide , oral contraceptive combined with a second method of contraceptive implant, injectable contraceptive, permanent intrauterine device, sexual abstinence or partner with vasectomy) during their participation in the study and in the 30 days following the last visit of the trial. In the case of patients, men with reproductive capacity can commit to using a suitable barrier method for the duration of the study and up to 6 months later.
    1. Pacientes de ambos sexos con edad ≤ 21 años.
    2. No tener disposición de un donante HLA idéntico (familiar o no) en el tiempo necesario para la donación de progenitores hematopoyéticos.
    3. Tener disposición de un donante haploidéntico.
    4. Diagnóstico de neoplasia hematológica de alto riesgo. Esto incluye:
    i. LLA de alto riesgo en primera remisión completa (RC1);
    ii. LLA en segunda remisión completa (RC2);
    iii. LLA en tercera remisión completa (RC3) o posterior;
    iv. LMA de alto riesgo en RC1;
    v. LMA en RC2 o posterior;
    vi. LMA en recaída con <25% de blastos en médula ósea;
    vii. LMA relacionada con tratamientos previos en RC> 12 meses;
    viii. Síndrome mielodisplásico primario o secundario;


    ix. Leucemia de células NK, bifenotípica o indiferenciada en RC1 o posterior,
    x. Leucemia mieloide crónica (LMC) en fase acelerada, en fase crónica con positividad molecular persistente, o con intolerancia a inhibidores de tirosin quinasa;
    xi. Linfoma de Hodgkin en RC2 o posterior tras fracaso de TPH autólogo, o incapaz de movilizar progenitores hematopoyéticos para un TPH autólogo;
    xii. Linfoma no Hodgkin en RC2 o posterior tras fracaso de TPH autólogo, o incapaz de movilizar progenitores hematopoyéticos para un TPH autólogo;
    xiii. Leucemia juvenil mielomonocítica.

    5. Evaluación previa al trasplante positiva:
    i. Fracción de eyección del ventrículo izquierdo > 40% o fracción de acortamiento ≥ 25%;
    ii. Aclaramiento de creatinina (ACr) o tasa de filtración glomerular (TFG) ≥ 50 ml/min/1,73 m2;
    iii. Capacidad vital forzada (CVF) ≥ 50% del valor predicho o pulso-oximetría ≥ 92% si el paciente no puede realizar las pruebas de función pulmonar;
    iv. Índice Karnofsky o Lansky (dependiendo de la edad del paciente) ≥ 50;
    v. Bilirrubina ≤ 3 veces el límite superior de lo normal para la edad;
    vi. Alanina aminotransferasa (ALT) ≤ 5 veces el límite superior de lo normal para la edad.
    vii. Mujeres que no se encuentren en periodo de lactancia.
    viii. Sin infecciones bacterianas, fúngicas o virales no controladas en el momento de la inclusión.

    6. Las mujeres con capacidad de procrear deben tener una prueba de embarazo negativa en suero o en orina realizada en los 14 días previos a la inclusión en el ensayo y deben acceder a usar métodos anticonceptivos altamente eficaces (diafragmas más espermicida o preservativo masculino más espermicida, anticonceptivo oral combinado con un segundo método de implante anticonceptivo, anticonceptivo inyectable, dispositivo intrauterino permanente, abstinencia sexual o pareja con vasectomía) durante su participación en el estudio y en los 30 días siguientes a la última visita del ensayo. En el caso de pacientes hombres con capacidad reproductiva, deberán comprometerse a utilizar un método de barrera adecuado mientras dure el estudio y hasta 6 meses después
    E.4Principal exclusion criteria
    1.Patients with active infectious process or other serious underlying medical condition.
    2. Patients who, according to the investigator's criteria, have a history of poor therapeutic compliance.
    3. Patients who after a psychosocial evaluation are advised as not suitable for the procedure:
    • Socio-family situation that prevents the correct participation in the study.
    • Patients with emotional or psychological problems secondary to the disease such as post-traumatic stress disorder, phobias, delusions, psychosis, requiring support by specialists.
    • Evaluation of the involvement of family members in the patient's health.
    4. Impossibility of understanding information about the trial.
    5. Having received a research drug during the 30 days prior to the start of therapy or being within 5 half-lives of receiving a research drug, whichever is longer.
    1.Pacientes con proceso infeccioso activo u otro estado médico subyacente grave.
    2. Pacientes que según criterio del investigador tengan antecedentes de mal cumplimiento terapéutico.
    3. Pacientes que tras una evaluación psico-social se aconsejan como no aptos para el procedimiento:
    • Situación socio-familiar que imposibilite la correcta participación en el estudio.
    • Pacientes con problemas emocionales o psicológicos secundarios a la enfermedad como trastorno de estrés postraumático, fobias, delirios, psicosis, con requerimiento de soporte por especialistas.
    • Evaluación de la implicación de los familiares en la salud del paciente.
    4. Imposibilidad de comprender la información sobre el ensayo.
    5. Haber recibido algún fármaco de investigación durante los 30 días previos al inicio de la terapia o encontrarse dentro de las 5 vidas medias de haber recibido un fármaco de investigación, lo que sea más prolongado.
    E.5 End points
    E.5.1Primary end point(s)
    Toxicity. In order to determine the safety, each patient will be monitored for possible adverse effects. For its assessment, CTCAE v5.0 in the NCI will be followed and the proportion of patients presenting toxicity based on grade will be determined. Toxic effects that cannot be classified according to the criteria for the toxicity of said system, will be classified as follows (MedDRA classification):
    -Mild (asymptomatic)
    -Moderate (symptomatic but not significantly interfering with the function)
    -Severe (causes significant function interference)
    -Threatening to life
    Toxicidad. Con el objetivo de determinar la seguridad cada paciente será monitorizado para la detección de posibles efectos adversos. Para su valoración se seguirán los criterios NCI-CTCEA V5.0 y se determinará la proporción de pacientes que presentan toxicidad en función del grado. Los efectos tóxicos que no puedan clasificarse de acuerdo a los criterios para la toxicidad del citado sistema, se clasificarán de la siguiente manera (clasificación MedDRA):
    -Leve (asintomático)
    -Moderado (sintomático pero que no interfiere significativamente con la función)
    -Severo (provoca una interferencia significativa de la función)
    -Amenazante para la vida
    E.5.1.1Timepoint(s) of evaluation of this end point
    36moths
    36meses
    E.5.2Secondary end point(s)
    The efficacy of post haploTPH NK cell therapy will be determined, comparing it with the historical cohort recently reported by GETH / GETMON in the incidence of:
    -Graft failure.
    -Acute / chronic GVHD
    -Viral reactivations (CMV, EBV, HHV-6, adenovirus, BKV).
    -Transplant related mortality (TRM).
    -Relapse of leukemia.
    The clinical evolution of the patients will be compared according to:
    • The dose of infused NK cells.
    • NK KIR match vs KIR mismatch cells.
    • The expansion, chimerism and phenotypic and functional characteristics of the infused NK.
    • The speed and characteristics of post haploTPH immune reconstitution.
    Monitor immune reconstitution by quantifying immunoglobulins at different times, and characterize NK cells in patients, at the phenotypic and functional level, for 1 year after haploTPH.
    Se determinará la eficacia de la terapia celular NK post haploTPH, comparándola con la cohorte histórica recientemente reportada por el GETH/GETMON en la incidencia de:
     Fallo del injerto.
     EICR agudo/crónico.
     Reactivaciones virales (CMV, VEB, HVH-6, adenovirus, BKV).
     Mortalidad relacionada con el trasplante (MRT).
     Recaída de la leucemia.
    Se comparará la evolución clínica de los pacientes en función de:
     La dosis de células NK infundidas.
     Células NK KIR match vs KIR mismatch.
     La expansión, quimerismo y las características fenotípicas y funcionales de las NK infundidas.
     La rapidez y las características de la reconstitución inmune post haploTPH.
    Monitorizar la reconstitución inmune mediante la cuantificación de inmunoglobulinas en diferentes momentos, y caracterizar las células NK en los pacientes, a nivel fenotípico y funcional, durante 1 año tras haploTPH.
    E.5.2.1Timepoint(s) of evaluation of this end point
    36Months
    36Meses
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Dose-scalation
    Escala de dosis
    E.7.2Therapeutic exploratory (Phase II) No
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Doble brazo. El tratamiento se proporcionará según las características del receptor-donante.
    Double arm. The treatment will be provided according the receptor-donor caractheristics.
    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.8.2.4Number 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 concerned10
    E.8.5The trial involves multiple Member States No
    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
    End of Follow up (LVLS)
    Final de seguimiento
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 18
    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) Yes
    F.1.1.3.1Number of subjects for this age range: 18
    F.1.1.4Infants and toddlers (28 days-23 months) Yes
    F.1.1.4.1Number of subjects for this age range: 18
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 18
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 18
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 18
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects under age of 12 years can only be included in the trial with the consent of their legal representative. Children
    Los sujetos menores de 12 años solo pueden ser incluidos en el estudio con el consentimiento de su representante legal. Niños
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state18
    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)
    Expected normal treatment of the disease
    Tratamiento normal esperado de esta enfermedad
    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 Decision2020-09-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-15
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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