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    Summary
    EudraCT Number:2019-000415-87
    Sponsor's Protocol Code Number:208467
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-08-09
    Trial results View 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 number2019-000415-87
    A.3Full title of the trial
    Master Protocol to Assess the Safety and Antitumor Activity of Genetically Engineered NY-ESO-1-Specific (c259) T Cells, alone or in combination with other agents, in HLA-A2+ Participants with NY-ESO-1 and/or LAGE-1a Positive Solid Tumors (IGNYTE-ESO)
    Protocolo maestro para evaluar la seguridad y actividad antitumoral de linfocitos T específicos de NY-ESO-1 (c259) modificados genéticamente, en monoterapia o en combinación con otros fármacos, en participantes con HLA-A2+ que presentan tumores sólidos positivos para NY-ESO-1 y/o LAGE-1a (IGNITE-ESO)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of NY-ESO-1 T-cells (GSK3377794) in synovial sarcoma patients
    Estudio de terapia celular de linfocitos T especifico de NY-ESO-1 (GSK3377794) en pacientes con sarcoma sinovial
    A.3.2Name or abbreviated title of the trial where available
    Assessment of safety & antitumor activity of GSK3377794 in NY-ESO-1+ and/or LAGE-1a+ solid tumors
    A.4.1Sponsor's protocol code number208467
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03967223
    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 SponsorGlaxoSmithKline, S.A.
    B.1.3.4CountrySpain
    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 supportGlaxoSmithKline, S. A.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline
    B.5.2Functional name of contact pointCentro de Información
    B.5.3 Address:
    B.5.3.1Street AddressC/Severo Ochoa, 2 (P.T.M.)
    B.5.3.2Town/ cityTres Cantos (Madrid)n
    B.5.3.3Post code28760
    B.5.3.4CountrySpain
    B.5.4Telephone number+34 902202700
    B.5.5Fax number+34 918070479
    B.5.6E-mailes-ci@gsk.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 Yes
    D.2.5.1Orphan drug designation numberEU/3/16/1694
    D.3 Description of the IMP
    D.3.1Product nameGSK3377794
    D.3.2Product code GSK3377794
    D.3.4Pharmaceutical form Dispersion 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 INNN/A
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeGSK3377794
    D.3.9.3Other descriptive nameNY-ESO-1c259T
    D.3.9.4EV Substance CodeSUB185001
    D.3.10 Strength
    D.3.10.1Concentration unit billion organisms billion organisms
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1 to 8
    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 No
    D.3.11.3.2Gene therapy medical product Yes
    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 Yes
    D.3.11.8Extractive medicinal product Yes
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    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
    Synovial sarcoma
    sarcoma sinovial
    E.1.1.1Medical condition in easily understood language
    Synovial sarcoma
    sarcoma sinovial
    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 PT
    E.1.2Classification code 10042863
    E.1.2Term Synovial sarcoma
    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 efficacy of NY-ESO-1-Specific (c259) T Cells, alone or in combination with other anti-cancer agents, in HLA-A*02:01, HLAA* 02:05 and/or HLA-A*02:06 participants with NY-ESO-1- and/or LAGE-1a positive solid tumors
    Evaluar la eficacia de linfocitos T específicos de NY-ESO-1 (c259), en monoterapia o en combinación con otros fármacos antitumorales, en participantes con HLA-A*02:01, HLA-A*02:05 y/o HLA-A*02:06 que presentan tumores sólidos positivos para NY-ESO-1 y/o LAGE-1a
    E.2.2Secondary objectives of the trial
    - To further evaluate the efficacy of NY-ESO-1 Specific (c259) T Cells alone or in combination with other anti-cancer agents in HLA-A*02:01, HLA-A*02:05 and/or HLA-A*02:06 participants with NY-ESO-1 and/or LAGE-1a positive solid tumors

    - To evaluate the safety and tolerability of NYESO- 1 Specific (c259) T Cells alone or in combination with other anti-cancer agents in HLA-A*02:01, HLA-A*02:05 and/or HLAA* 02:06 participants with NY-ESO-1- and/or LAGE-1a positive solid tumors
    - Evaluar más a fondo la eficacia de linfocitos T específicos de NY-ESO-1 (c259), en monoterapia o en combinación con otros fármacos antitumorales, en participantes con HLA-A*02:01, HLA-A*02:05 y/o HLA-A*02:06 que presentan tumores sólidos positivos para NY-ESO-1 y/o LAGE-1a

    - Evaluar la seguridad y tolerabilidad de linfocitos T específicos de NY-ESO-1 (c259), en monoterapia o en combinación con otros fármacos antitumorales, en participantes con HLA-A*02:01, HLA-A*02:05 y/o HLA-A*02:06 que presentan tumores sólidos positivos para NY-ESO-1 y/o LAGE-1a
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    SUBSTUDY 1: GSK3377794 IN PREVIOUSLY UNTREATED ADVANCED METASTATIC OR UNRESECTABLE SYNOVIAL SARCOMA

    SUBSTUDY 2: PREVIOUSLY TREATED ADVANCED METASTATIC OR UNRESECTABLE NY-ESO-1-POSITIVE SYNOVIAL SARCOMA
    SUBESTUDIO 1: GSK3377794 EN SARCOMA SINOVIAL NO RESECABLE O METASTÁSICO AVANZADO SIN TRATAMIENTO PREVIO

    SUBESTUDIO 2: GSK3377794 EN SARCOMA SINOVIAL POSITIVO PARA NY-ESO-1 NO RESECABLE O METASTÁSICO AVANZADO TRATADO PREVIAMENTE
    E.3Principal inclusion criteria
    - Subject must be ≥10 years of age at the time of signing the informed consent.
    - Subject has a diagnosis of synovial sarcoma confirmed by histology.
    - Subject has advanced (metastatic or unrespectable) synovial sarcoma.
    - In substudy 1, subject with metastatic synovial sarcoma who is newly diagnosed or previously untreated
    - In substudy 2, at the time of treatment, subject has received/completed treatment with anthracycline or anthracycline with ifosfamide for advanced (metastatic or inoperable) disease and progressed.
    - Male or female. Contraception requirements will apply at the time of leukapheresis and treatment.
    - Subject must be positive for HLA-A*02:01, HLA-A*02:05, and/or HLA-A*02:06 alleles by a validated test in a designated central laboratory.
    - Subjects tumor has been pathologically reviewed by a designated central laboratory with confirmed positive NY-ESO-1 expression
    - Performance status: Eastern Cooperative Oncology Group of 0-1.
    - Subject must have adequate organ function and blood cell counts 7 days prior to leukapheresis.
    - Female subjects of childbearing potential must have a negative urine or serum pregnancy test.
    - Subject has measurable disease according to RECIST v1.1.
    - Supportive radiotherapy has not affected >25% of bone marrow.


    For a detailed list of Inclusion Criteria's please refer to the protocol
    - El participante debe tener ≥10 años de edad en el momento de la firma del consentimiento informado.
    - Participantes con un diagnóstico de sarcoma sinovial confirmado por histología.
    - El sujeto padece sarcoma sinovial avanzado (metastásico o no resecable).
    - El subestudio 1, sujetos con sarcoma sinovial no resecable o metastásico sin tratamiento previo de nuevo diagnóstico.
    - En subestudio 2, en el momento del tratamiento, el participante ha recibido/completado el tratamiento con antraciclinas o antraciclinas con ifosfamida para enfermedad avanzada (metastásica o inoperable). y progresaron.
    - Mujeres o hombres. El uso de anticonceptivos será necesario en el momento de la leucoféresis y en el tratamiento.
    - Los participantes deben presentar un resultado positivo para los alelos HLA-A*02:01, HLA-A*02:05 y/o HLA-A*02:06 en pruebas validadas en un laboratorio central designado
    - Un laboratorio central designado ha realizado la revisión patológica del tumor del participante con expresión positiva confirmada de NY-ESO-1.
    - Estado funcional: Eastern Cooperative Oncology Group (ECOG) de 0-1.
    - Los participantes deben presentar una función orgánica y hemogramas adecuados. 7 días antes de la leucoféresis.
    - Las mujeres en edad fértil deben presentar una prueba de embarazo en suero u orina negativa.
    - El participante dispone de enfermedad medible conforme a los criterios RECIST v1.1.
    - La radioterapia de soporte no ha afectado a >25% de la médula ósea.

    Para una lista detallada de los Criterios de Inclusión por favor consulte el Protocolo.
    E.4Principal exclusion criteria
    - In substudy 1, subject has been previously treated for metastatic synovial sarcoma.
    - Central nervous system metastases.
    - Any other prior malignancy that is not in complete remission.
    - Previous treatment with genetically engineered NY-ESO-1-specific T cells.
    - Previous NY-ESO-1 vaccine or NY-ESO-1 targeting antibody.
    - Prior gene therapy using an integrating vector.
    - Previous allogeneic hematopoietic stem cell transplant.
    - Clinically significant systemic illness: serious active infections or significant cardiac, pulmonary, hepatic or other organ dysfunction, that in the judgment of the Investigator would compromise the subject’s ability to tolerate protocol therapy or significantly increase the risk of complications, or, prior or active demyelinating disease.
    - Subject has history of chronic or recurrent (within the last year prior to leukapheresis) severe autoimmune or immune mediated disease requiring steroids or other immunosuppressive treatments.
    - Uncontrolled intercurrent illness
    - Current active liver or biliary disease.
    - Pregnant or breastfeeding females (due to risk to fetus or newborn).
    - Prior/concomitant therapy: any prior treatment-related toxicities must be Common terminology criteria for adverse events <=Grade 1 at the time of initiating study intervention (except for non-clinically significant toxicities).
    - Other standard of care lines of therapy are allowed only if guidelines and washout periods are followed.
    - Subject has active infection as defined in the protocol
    - Subject has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study.
    - Subject had major surgery ≤28 days of first dose of study intervention.

    For a detailed list of Exclusion Criteria's please refer to the Protocol
    - En el subestudio 1, el sujeto ha recibido tratamiento previo para el sarcoma sinovial metastásico.
    - Metástasis en el sistema nervioso central.
    - Cualquier otra neoplasia maligna previa que no se encuentra en remisión completa.
    - Tratamiento previo con linfocitos T específicos de NY-ESO-1 modificados genéticamente.
    - Vacuna frente a NY-ESO-1 previa o anticuerpo dirigido a NY-ESO-1.
    - Terapia génica previa utilizando un vector de integración.
    - Trasplante alogénico de progenitores hematopoyéticos previo.
    - Enfermedad sistémica clínicamente significativa: infecciones activas graves o insuficiencia cardiaca, pulmonar, hepática significativa u otra disfunción orgánica que, a juicio del investigador, puede comprometer la capacidad del participante de tolerar el tratamiento del protocolo o aumentar de manera significativa el riesgo de complicaciones, o, enfermedad desmielinizante previa o activa
    - El participante tiene antecedentes de una enfermedad inmunomediada o autoinmunitaria grave crónica o recurrente (en el último año antes de la leucoféresis) que requiere corticoesteroides u otro tratamiento inmunosupresor.
    - Enfermedad intercurrente no controlada
    - Mujeres embarazadas o en periodo de lactancia (debido al riesgo para el feto o el recién nacido).
    - Tratamiento previo/concomitante: Cualquier toxicidad previa relacionada con el tratamiento debe ser de grado ≤1 en el momento de iniciar el tratamiento del estudio (salvo toxicidades que no son clínicamente significativa).
    - Se permiten otras líneas del tratamiento de referencia solo si se siguen las guías y los periodos de reposo farmacológico.
    - Sujetos con una infección activa tal como se define en el Protocolo
    - Padece un trastorno psiquiátrico o de abuso de sustancias conocido que puede interferir con la cooperación con los requisitos del estudio.
    - El sujeto se ha sometido a cirugía mayor ≤28 días desde la primera dosis del tratamiento del estudio.

    Para una lista detallada de los Criterios de Exclusión por favor consulte el Protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response Rate (ORR) per RECIST v1.1
    Tasa de respuestas global (TRG) según RECIST v1.11
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 5 Years
    Hasta 5 años
    E.5.2Secondary end point(s)
    To further evaluate the efficacy of NY-ESO-1
    - Time to Response (TTR)
    - Duration of Response (DoR)
    - Disease Control Rate (DCR)
    - Progression Free Survival (PFS)
    - Overall Survival (OS)

    To evaluate the safety and tolerability of NYESO-1
    - Adverse events (AEs) including serious adverse events (SAEs)
    - Incidence, severity and duration of the AEs of special interest (AESI; as defined in protocol)
    - Laboratory parameters
    - Replication Competent Lentivirus (RCL)
    - T cell Persistence: Maximum transgene expansion (Cmax), time to Cmax (Tmax), and persistence (area under the time curve from zero to time t
    AUC(0-t)), as data permit
    - Instances of Insertional oncogenesis (IO)
    Para evaluar mas a fondo la eficacia de linfocitos T específicos de NY-ESO-1
    - Tiempo hasta la respuesta (TTR)
    - Duración de la respuesta (DdR)
    - Tasa de control de la enfermedad (TCE)
    - Supervivencia libre de progresión (SLP)
    - Supervivencia global (SG)

    Para evaluar la seguridad y tolerabilidad de linfocitos T específicos de NY-ESO-1
    - Acontecimientos adversos (AA) incluyendo acontecimientos adversos graves (AAG)
    - Incidencia, gravedad y duración de AA de especial interés (AAEI; según la definición del protocolo)
    - Parámetros analíticos
    - Lentivirus competente para replicación (LCR)
    - Persistencia de linfocitos T: expansión transgénica máxima (Cmáx), tiempo hasta Cmáx (Tmáx) y persistencia (área bajo la curva temporal desde 0 hasta el tiempo t, ABC(0-t)), si los datos lo permiten
    - Aparición de oncogénesis por inserción (OI)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 5 Years
    Hasta 5 años
    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 No
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    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
    Canada
    France
    Germany
    Italy
    Netherlands
    Spain
    United Kingdom
    United States
    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
    LSLV
    Última visita del último paciente
    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 months3
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years6
    E.8.9.2In all countries concerned by the trial months3
    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: 2
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 1
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 1
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 22
    F.4.2.2In the whole clinical trial 65
    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)
    In accordance with the FDA and European Medicines Agency (EMA) requirements for gene therapy clinical trials, all participants completing the Interventional Phase of the study will be rolled over to a LTFU protocol (GSK Study 208750) for observation of delayed AEs and survival for 15 years post GSK3377794 infusion.
    De acuerdo a los requerimientos de la FDA y EMA para ensayos clínicos en terapia génica, todos los participantes que completen la fase intervencional del estudio serán incluidos en un protocolo de seguimiento a largo plazo (estudio 208750) para el seguimiento de los Efectos adversos que puedan ocurrir con posterioridad al estudio principal y evaluar supervivencia durante los 15 años siguientes a la infusión de GSK3377794.
    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 Decision2020-02-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-24
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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