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    Summary
    EudraCT Number:2012-005327-33
    Sponsor's Protocol Code Number:CFTSp060
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2013-07-01
    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 ConcernedUK - MHRA
    A.2EudraCT number2012-005327-33
    A.3Full title of the trial
    A Phase II Trial to Assess the Activity of NY-ESO-1 Targeted T Cells in Advanced Oesophagogastric Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II clinical trial to assess the activity of NY-ESO- 1 targeted T cells in advanced oesophago-gastric cancer
    A.3.2Name or abbreviated title of the trial where available
    Phase II Trial of NY-ESO-1 Targeted T Cells in Oesophagogastric Cancer
    A.4.1Sponsor's protocol code numberCFTSp060
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT01795976
    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 SponsorThe Christie NHS Foundation Trust
    B.1.3.4CountryUnited Kingdom
    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 supportFP7
    B.4.2CountryEuropean Union
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationThe Christie NHS Foundation Trust
    B.5.2Functional name of contact pointIan Emerson
    B.5.3 Address:
    B.5.3.1Street Address550 Wilmslow Road
    B.5.3.2Town/ cityManchester
    B.5.3.3Post codeM20 4BX
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01619187443
    B.5.6E-mailian.emerson@christie.nhs.uk
    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 nameNYESO T cells
    D.3.2Product code NYESO-1 T cells
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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 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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced Oesophago-gastric Cancer
    E.1.1.1Medical condition in easily understood language
    Generally, advanced gastro-oesophageal cancer means the cancer has spread from where it first started in the food pipe or stomach to other parts of the body.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    E.1.2Level LLT
    E.1.2Classification code 10056267
    E.1.2Term Gastroesophageal cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Is using the patient's own engineered cells as a therapy effective in treating oesophago-gastric cancer (as an example of a common epithelial malignancy) where there is a clear need for more effective therapies?
    Primary objective: To evaluate the response rate in Oesophagogastric cancer patients who are NYESO-1 and HLA-A2 positive to adoptive cell therapy targeted to NYESO-1
    E.2.2Secondary objectives of the trial
    1. Evaluating if this treatment is feasible, and if it is tolerated by the patient.
    2. Evaluation of the duration of remission of the cancer.
    3. Assessment of the time from when the treatment was given to time of death
    4. Evaluation of blood samples to assess specific tumour marker responses.
    5. Evaluation of the cancer response rate by a new unvalidated assessment method - Immune Response Criteria
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pre-screening:
    • Patients must be HLA-A0201 positive on pre-screen blood test
    • If confirmed HLA-A0201 positive, subjects tumour sample must stain positive by immunohistochemistry for NY-ESO-1 and/or LAGE (either diagnostic or more recent biopsy is acceptable. Subject may require additional biopsy if insufficient tumour material available form diagnostic sample).
    Main Study:
    • Patients must have histologically confirmed oesophagogastric cancer and have received prior chemotherapy.
    • Confirmed evidence of measurable metastatic disease (by RECISTv1.1)
    • Patients may have had any previous systemic therapies provided they are otherwise fit for treatment
    • Age equal to or greater than 18 years
    • World Health Organisation (WHO) performance status of 0 or 1
    • Life expectancy >3months
    • LVEF > 50% as measured by ECHO or MUGA
    • Haematological and biochemical indices:
    (i) Haemoglobin (Hb) ≥ 80 g/L
    (ii) Neutrophils ≥ 1.0 x 109/L
    (iii) Platelets (Plts) ≥ 100 x 109/L
    • Any of the following abnormal baseline liver function tests:
    (i) serum bilirubin 1.5 x ULN
    (ii) alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 5 x ULN and/or Serum creatinine ≤ 150 μmol/L or creatinine clearance > 50 ml/min.
    These measurements must be performed prior to leukaphereses and again prior to commencing preconditioning chemotherapy.
    • The chemotherapy to be used in this trial is non-myeloablative, but where there is concern about a patient’s bone marrow reserves, for example due to multiple previous lines of myelosuppressive chemotherapy a backup stem cell harvest should also be obtained.
    • Female patients of child-bearing potential must have a negative serum or urine pregnancy test prior to treatment and agree to use appropriate medically approved contraceptive precautions for four weeks prior to entering the trial, during the trial, and for six months afterwards.
    • Male patients must agree to use barrier method contraception during the treatment and for six months afterwards.
    • Full written informed consent
    E.4Principal exclusion criteria
    • Those receiving radiotherapy, biological therapy, endocrine therapy, immunotherapy, systemic steroids, or chemotherapy during the previous four weeks (six weeks for nitrosoureas and Mitomycin-C) prior to treatment or during the course of the treatment.
    • All toxic manifestations of previous treatment must have resolved. Exceptions to this are alopecia or certain Grade 1 toxicities, which an investigator considers should not exclude the patient.
    • Participation in any other clinical trial within the previous 30 days or during the course of this treatment.
    • Previous allogeneic transplant.
    • Clinically significant cardiac disease. Examples would include unstable coronary artery disease, myocardial infarction within 6 months or Class III or IV AHA criteria for heart disease
    • Patients who are high medical risks because of non-malignant systemic disease, including those with, uncontrolled cardiac or respiratory disease, or other serious medical or psychiatric disorders which in the lead clinicians opinion would not make the patient a good candidate for adoptive T-cell therapy
    • Concurrent systemic infections (CTCAE Grade 3 or more) within the 28 days prior to treatment.
    • Prior history of malignancies at other sites, with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin.
    • Patients known or found to be serologically positive for Hepatitis B, C, HIV or HTLV.
    • History of systemic autoimmune disease which could be life-threatening if reactivation occurred (for example hypothyroidism would be permissible, prior rheumatoid arthritis or SLE would not).
    • Evidence of CNS involvement.
    • Patients who are likely to require systemic steroids or other immunosuppressive therapy.
    • Pregnant and lactating women.
    • Radiotherapy to >25% skeleton.
    E.5 End points
    E.5.1Primary end point(s)
    Response rate by RECIST (Response Evaluation Criteria In Solid Tumors)criteria in oesophagogastric cancer patients who are NY-ESO-1 and HLA-A2 positive to adoptive cell therapy targeted to NY-ESO-1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    CT scans to assess RECIST response will be conducted pre-treatment for baseline assessment, and then post-treatment at 6 weeks, 12 weeks, 24 weeks, and 12 weekly thereafter until progression is confirmed.
    E.5.2Secondary end point(s)
    - Evaluation of feasibility and tolerability of adoptive cell therapy targeted to NY-ESO-1 in Oesophagogastric cancer patients who are NY-ESO-1 positive and HLA-A2 positive.
    - Evaluation of the duration of remission
    - Assessment of overall survival
    - Evaluation of response rate by Immune Response Criteria
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Feasibility will be assessed at the end of the study by the proportion of patients who received full therapy. Tolerability of therapy will be assessed by Common Toxicity Criteria for Adverse Events v4.0 throughout study duration, until patient progresses.
    - Progression free survival will be assessed throughout study, as patients followed up until progression. Overall figure will be calculated at recruitment of 15 patients, and then at completion of study.
    - Overall survival will be assessed at recruitment of 15 patients, and then at completion of study.
    - Response rate by Immune Response Criteria will be assessed pre-treatment for baseline assessment, and then post-treatment at 6 weeks, 12 weeks, 24 weeks, and 12 weekly thereafter until progression is confirmed.
    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 Yes
    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 No
    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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days1
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 28
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 28
    F.4.2.2In the whole clinical trial 28
    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)
    Not applicable. THe NY-ESO-1 cells are given once only. The patient will receive followup and assesment as per standard of care once the research has finished.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-03-26
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2017-11-30
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