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    Summary
    EudraCT Number:2019-000415-87
    Sponsor's Protocol Code Number:208467
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-30
    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 ConcernedNetherlands - Competent Authority
    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)
    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 and myxoid/round cell liposarcoma patients
    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 Research & Development Ltd
    B.1.3.4CountryUnited Kingdom
    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 Research & Development Ltd
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGlaxoSmithKline Research & Development Ltd
    B.5.2Functional name of contact pointGSK Clinical Support Help Desk
    B.5.3 Address:
    B.5.3.1Street Address980 Great West Road
    B.5.3.2Town/ city Brentford, Middlesex
    B.5.3.3Post codeTW8 9GS
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+44 800 783 9733
    B.5.5Fax numberNot Applicable
    B.5.6E-mailGSKClinicalSupportHD@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 number EU/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 code Letetresgene autoleucel (lete-cel; GSK3377794)
    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 15
    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 and Myxoid/Round Cell Liposarcoma (MRCLS)
    E.1.1.1Medical condition in easily understood language
    Synovial sarcoma and Myxoid/Round Cell Liposarcoma (MRCLS)
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10073137
    E.1.2Term Myxoid liposarcoma
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10073139
    E.1.2Term Round cell liposarcoma
    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
    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 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
    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: LETETRESGENE AUTOLEUCEL (LETE-CEL, GSK3377794) IN NY-ESO-1 POSITIVE PREVIOUSLY UNTREATED ADVANCED (METASTATIC OR UNRESECTABLE) SYNOVIAL SARCOMA AND MYXOID/ROUND CELL LIPOSARCOMA

    SUBSTUDY 2: LETETRESGENE AUTOLEUCEL (LETE-CEL, GSK3377794) IN NY-ESO-1 POSITIVE PREVIOUSLY TREATED ADVANCED (METASTATIC OR UNRESECTABLE) SYNOVIAL SARCOMA OR MYXOID/ROUND CELL LIPOSARCOMA
    E.3Principal inclusion criteria
    1. For participants <18 years of age, (or the legal minimum age in the relevant country) their legal guardian must give informed
    consent.Pediatric subjects will be included in age-appropriate discussion in order to obtain assent.
    2.Participant must be ≥10 years of age at the time of signing the informed consent. Participant scheduled to receive clinical drug product supply must also weigh ≥40 kg. For participant scheduled to receive intended commercial drug product supply and weighing <40kg, the Investigator must also consult with the Medical Monitor prior to inclusion.
    3.Participant has a diagnosis of synovial sarcoma or myxoid/ round cell liposarcoma, confirmed by local histopathology with evidence of diseasespecific translocation.
    Note: Evidence of a relevant disease-specific translocation is required at latest prior to leukapheresis (Inclusion 8).
    4. Participant has advanced (metastatic or unresectable) synovial sarcoma or myxoid/round cell liposarcoma. Unresectable refers to a tumor lesion in which clear surgical excision margins cannot be obtained without leading to significant functional compromise.
    5. Male or female. Contraception requirements will apply at the time of leukapheresis and treatment.
    6. A representative tumor tissue specimen (archived or fresh biopsy) with associated pathology report should be available to perform NY-ESO-1 antigen expression analysis, unless a recent NY-ESO-1 expression test result from the same designated central laboratory, following the same procedures, has already been performed under a separate GSKsponsored protocol or under another substudy. For guidance on acceptable specimen material see Tumor Biopsies under Section 5.1 Leukapheresis Eligibility Screening
    -Prior to finalizing participant treatment plan, please note that bridging/standard of care anti-cancer therapy is allowed under Section 7.1.2 conditions but that there are washout requirements prior to leukapheresis and prior to lymphodepletion. Additional considerations should be given to accumulated radiotherapy prior to lymphodepletion.All the Inclusion Criteria from Section 6.1.1 must apply again prior to leukapheresis. In addition, the following criteria must also apply:
    7. Life expectancy ≥24 weeks
    8. Participant has confirmed evidence of a relevant disease-specific translocation per below:
    • For synovial sarcoma, presence of a translocation involving chromosome 18 (SYT gene) and/or chromosome X (SSX1, SSX2 or SSX4 genes);
    • For myxoid/round cell liposarcoma, presence of a translocation involving chromosome 12 (DDIT3 gene) and/or chromosome 16 (FUS gene) and/or chromosome 22 (EWSR1 gene).
    Note: Methods, such as, but not limited to, fluorescence in situ hybridization (FISH) assay or Next Generation Sequencing (NGS) or Immuno HistoChemistry (IHC) using fusion-specific antibody are commonly used to detect translocations.
    9. Participant is either currently being treated with or has completed at least one standard-of-care treatment including anthracycline-containing regimens (e.g., doxorubicin alone, doxorubicin with ifosfamide) for advanced (metastatic or inoperable) disease. Participants who are intolerant to anthracycline may receive ifosfamide alone unless intolerant to or ineligible to receive ifosfamide. Participants who received anthracycline-based therapy in the neoadjuvant/adjuvant setting and progressed will be eligible.
    10.Participant 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 lab prior to leukapheresis. NOTE: If a participant was previously tested for HLA type under a different GSK-sponsored protocol, testing of HLA type for 208467 may not be required dependent on the test platform(s) used and whether they meet the 208467 protocol requirements [see Section 6.3 of the Core Protocol]).
    11.Participant's tumor has been pathologically reviewed by a designated central laboratory with confirmed positive NY-ESO-1 expression defined as ≥30% of cells that are 2+ or 3+ by immunohistochemistry.
    NOTE: If a participant was previously tested for NY-ESO-1 expression under a different GSK-sponsored protocol, testing of NY-ESO-1 expression for 208467 may not be required dependent on the test platform(s) used and whether they meet the 208467 protocol requirements [see Section 6.3 of the Core Protocol]).
    12. Left ventricular ejection fraction ≥45% with no evidence of clinically significant pericardial effusion.
    13. Performance status: for participants <16 years of age, Lansky >60, or for participants ≥16 and <18 years of age, Karnofsky >60, or for participants ≥18 years of age, Eastern Cooperative Oncology Group (ECOG) of 0-1.
    14.Participant must have adequate organ function and blood cell counts, within 7 days prior to the day of leukapheresis procedure , as indicated by the protocol. For a detailed list of Inclusion Criteria's please refer to the protocol Page No. 173-178
    E.4Principal exclusion criteria
    1.Participant has been previously treated for advanced (metastatic or unresectable) synovial sarcoma or myxoid/round cell liposarcoma.
    2. Central nervous system metastases.
    3. Any other prior malignancy that is not in complete remission. Exceptions include:
    a. completely resected non-melanoma skin cancer, or successfully treated in situ carcinoma (e.g. melanoma in situ, basal cell carcinoma, prostate cancer in-situ, periosteal osteosarcoma)
    b. previous malignancies that have been definitively treated, and have been in remission for 5 years may be enrolled upon consultation with sponsor Medical Monitor or designee
    4. Previous treatment with genetically engineered NY-ESO-1-specific T cells.
    5. Previous NY-ESO-1 vaccine or NY-ESO-1 targeting antibody.
    6. Prior gene therapy using an integrating vector.
    7. Previous allogeneic hematopoietic stem cell transplant.
    8. 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. Leukapheresis Eligibility Screening: Participants are not eligible for leukapharesis if any of the Exclusion criteria from section 6.2.1 apply.
    Please note in particular that mandatory washout period restrictions must be respected (Table 5) before starting leukapheresis. In addition, participants are not eligible for leukapharesis if any of the following criteria apply:
    9.Participant has history of chronic or recurrent (within the last year prior to leukapheresis) severe autoimmune or immune mediated disease (e.g. Crohn's disease, systemic lupus) requiring steroids or other immunosuppressive treatments.
    10. Uncontrolled intercurrent illness including, but not limited to:
    a. Ongoing or active infection (including, but not limited to systemic fungal infection)
    b. Clinically significant cardiac disease defined by congestive heart failure New York Heart Association (NYHA) Class 3 /Class 4
    c. Uncontrolled clinically significant arrhythmia
    d. Acute coronary syndrome (angina or myocardial infarction) in last 6 months
    e. Interstitial lung disease (participants with existing pneumonitis as a result of radiation are not excluded; however, participants cannot be oxygen dependent)
    11. Current active liver or biliary disease.
    12. QTc >480 msec
    13. Participant has a history of allergic reactions attributed to compounds of similar chemical or biologic composition to
    cyclophosphamide, fludarabine, other agents used in the study.
    14. Pregnant or breastfeeding females (due to risk to fetus or newborn).
    15. 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.
    16. Investigational treatment within 30 days or 5 half-lives (whichever is shorter) prior to leukapheresis. Investigational vaccines (other than NY-ESO-1 vaccines that are not allowed) must follow the washout period Investigator in agreement with the Sponsor's Medical Monitor
    17. Participant has active infection with HIV, HBV, HCV, EBV, CMV, syphilis, or HTLV as defined in the protocol
    18. has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the study. Please note that mandatory washout period restrictions must be respected (Table 5) before starting lymphodepletion. In addition to confirming Treatment fitness per Section 6.2.3.1, participants cannot proceed with lymphodepletion or treatment if any of the following criteria apply
    19. Participant has received cytotoxic therapy within 3 weeks prior to lymphodepleting chemotherapy.
    20. Systemic corticosteroids or any other immunosuppressive therapy within 2 weeks prior to lymphodepleting chemotherapy.
    21. Participant has received ≥50 Gy to a significant volume of the pelvis, long bones or spine, or a cumulative dose of radiation that, in the Investigator's opinion would predispose patients to prolonged cytopenia after lymphodepletion.
    22. All of the participant's measurable lesions have been irradiated within 3 months prior to lymphodepletion. An irradiated measurable lesion with unequivocal progression following irradiation may be considered a target lesion regardless of time from last radiotherapy dose.
    23.Participant has received live vaccine within 4 weeks prior to lymphodepletion or intends to receive live vaccine during the 3 month period following administration of lete-cel.

    For a detailed list of Exclusion Criteria's please refer to the Protocol Page N. 178-182.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response Rate (ORR) per RECIST v1.1 (assessed by investigator for Substudy 1 and assessed by independant review committee for Substudy 2)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 5 Years
    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) for Substudy 2



    To evaluate the safety and tolerability of NYESO-1
    - Frequency and severity of Adverse events (AEs), serious adverse events (SAEs) and AEs of special interest (AESI; as defined in protocol).
    -Laboratory parameters
    -Replication Competent Lentivirus (RCL)
    - Instances of Insertional oncogenesis (IO)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 5 Years
    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 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 Yes
    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 EEA13
    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
    United States
    France
    Netherlands
    Spain
    Germany
    Italy
    United Kingdom
    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
    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: 3
    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: 6
    F.1.2Adults (18-64 years) No
    F.1.2.1Number of subjects for this age range: 65
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 9
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 37
    F.4.2.2In the whole clinical trial 97
    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.
    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 Decision2019-07-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-23
    P. End of Trial
    P.End of Trial StatusOngoing
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