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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2015-000402-19
    Sponsor's Protocol Code Number:TCB-101-001
    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:2015-05-20
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-000402-19
    A.3Full title of the trial
    An Adaptive Study of the Safety, Tolerability and Efficacy of Autologous γδ T Lymphocyte Therapy (ImmuniCell®) in Patients with Advanced Cancers which are Refractory to Current Treatment or who have Indolent Disease for which Immunotherapy may be Beneficial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical trial to study the safety and efficacy of ImmuniCell®: using a person's own immune cells to treat cancers.
    A.3.2Name or abbreviated title of the trial where available
    Autologous Gamma Delta T Cell Therapy (ImmuniCell®) in Advanced Cancer
    A.4.1Sponsor's protocol code numberTCB-101-001
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN26113637
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02459067
    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 SponsorTC BioPharm 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 supportCommercial funding from Sponsor
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTC BioPharm
    B.5.2Functional name of contact pointVP Clinical
    B.5.3 Address:
    B.5.3.1Street AddressMaxim 1, 2 Parklands Way
    B.5.3.2Town/ cityHolytown
    B.5.3.3Post codeML1 4WQ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number01414337557
    B.5.6E-mailt.zaremba@tcbiopharm.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 nameImmuniCell®
    D.3.2Product code TCB-101
    D.3.4Pharmaceutical form 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 INNγδ T lymphocytes
    D.3.9.2Current sponsor codeTCB-101
    D.3.9.3Other descriptive nameImmuniCell®
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1 x 10^9 cells to 10 x 10^9 cells
    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 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, malignant melanoma, non-small cell lung cancer and renal cell carcinoma.
    E.1.1.1Medical condition in easily understood language
    Advanced skin, lung and kidney cancer.
    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 10025650
    E.1.2Term Malignant melanoma
    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 10067946
    E.1.2Term Renal cell carcinoma
    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 10061873
    E.1.2Term Non-small cell lung cancer
    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
    The trial is an accelerated design in three stages, each stage having a different principal objective:

    Stage 1: The first stage of the study aims to identify a safe dose of ImmuniCell® to use in Stage 2 of the study.

    Stage 2: The principal objective of this stage of the study is to identify one or more tumour types which respond to treatment with ImmuniCell® according to pre-set rules and to look at the safety of ImmuniCell® treatment. Subjects with either skin cancer (malignant melanoma), lung cancer (non-small cell lung cancer) or kidney cancer (renal cell carcinoma) will participate in the study.

    Stage 3: This stage of the study will confirm, in a larger number of subjects, that ImmuniCell® is effective and safe in the cancer which had the highest response to treatment in the second stage of the study. This stage will be subject to a protocol amendment.
    E.2.2Secondary objectives of the trial
    The secondary objectives of the study are:

    To study the efficacy of ImmuniCell® treatment.

    To determine if ImmuniCell® treatment stimulates the immune system to mount an immune response with the potential to reduce the size of tumours.

    To try to identify a blood chemical which may give an indication that ImmuniCell® treatment is working (a biological response marker). This marker could be used in the future to judge if the treatment is working before scans are done to look for tumour reductions.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female patients aged ≥18 years
    2. Performance status ECOG 0 or 1 (Appendix 1)
    3. Subjects with histological or cytological confirmation of advanced malignant melanoma, renal cell carcinoma or NSCLC which are refractory to current standard treatments or who have indolent disease for which immunotherapy may be beneficial
    4. Measurable disease according to the irRC criteria
    5. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted <2 weeks prior to Cycle 1:
    a. Creatinine ≤ 1.5 x upper limit of normal (ULN) OR a calculated creatinine clearance ≥ 50 ml/min
    b. Total bilirubin ≤ 1.5 x ULN
    c. Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 x ULN or ≤ 5 x ULN with liver metastases
    d. Absolute lymphocyte count ≥1.0 x 109/L
    e. Absolute Neutrophil Count (ANC) ≥1.5 x 109/L
    f. Platelets ≥100 x 109/L
    g. Haemoglobin ≥ 10 g/dL
    6. Life expectancy of at least 3 months
    7. Adequate increase in starting γδ T cell number to final γδ T cell number in the proliferation assay
    8. Able to give informed, written consent
    9. For female patients and female partners of male patients: must be surgically sterile, postmenopausal, or compliant with two forms of contraception (one of which must be a barrier method) during and for 6 months after the treatment period; female patients must have a negative urine pregnancy test at screening and must not be breast-feeding.
    E.4Principal exclusion criteria
    1. Other primary cancers apart from non-melanoma skin cancers, carcinoma – in situ of the cervix, or a prior cancer treated with curative intent more than 2 years ago without any evidence or recurrent disease
    2. Uncontrolled systemic infection
    3. Systemic steroid therapy or other immune-suppressants (except in cases where the patient is receiving treatment with replacement doses for adrenal insufficiency)
    4. Treatment with bisphosphonates, for instance zoledronate, in the previous 3 months or throughout the trial
    5. New York Heart Association (NYHA) functional class ≥3 (Appendix 4) or myocardial infarction within 6 months
    6. Clinically significant uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation not requiring therapy
    7. Ulcerative Colitis / Inflammatory bowel disease, Addison’s disease
    8. Pregnancy or lactation prior to or during the trial. A urine pregnancy test will be carried out at screening
    9. Taking any other IMP or participation in another interventional clinical trial in the previous 30 days
    10. Less than 4 weeks since systemic anti-cancer therapy (tyrosine kinase inhibitors, chemotherapy, immunotherapy, hormonal therapy, radiotherapy) and more than 6 weeks since mitomycin C and nitrosureas
    11. Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the trial or evaluation of the trial results
    12. Any other condition considered by a trial physician to be inappropriate for inclusion to the study such as contraindications to leukapheresis (contraindications to heparin which are: recent cerebral haemorrhage; peptic ulcer; recent surgery to eye or nervous system; hypersensitivity to heparin; past history of Type II heparin induced thrombocytopenia; past history of significant spontaneous haemorrhage; known haemophilia or other bleeding disorder)
    13. Serological evidence of active infection with HIV, hepatitis B/C, HTLV and syphilis.
    E.5 End points
    E.5.1Primary end point(s)
    Stage 1

    • Proportion of patients with drug-related > grade 3 toxicity (except for nausea, vomiting or grade 3 diarrhoea without maximal supportive therapy; anaemia, alopecia, or asymptomatic grade 3 laboratory findings that last for < 7 days)
    • Number, type and severity of toxicities and their relationship to treatment


    Stage 2

    Tumour response (immediate or delayed CR, PR, SD or PD) by irRC

    Number, type and severity of toxicities and their relationship to treatment

    Stage 3

    To be decided on evaluation of Stage 2 by DRC. A protocol amendment will be submitted to Ethics and Competent Authority for consideration prior to commencement
    E.5.1.1Timepoint(s) of evaluation of this end point
    Stage 1

    During the active treatment:

    Weeks 0, 2, 4, 6, 8 and 10 after baseline

    or by notification by the participants at any time during treatment.

    Stage 2

    Tumour response will be evaluated at:

    6, 12, 18, 24 36 and 48 weeks after baseline.

    Adverse events and safety blood assessments will be done at each visit.

    Stage 3

    The timepoints for evaluations will be determined after Stage 2 when the study design can be formulated.
    E.5.2Secondary end point(s)
    Stage 1

    • Changes markers of immune response (such as IFN-γ, IL-2 and TNF-α) before the first and subsequent ImmuniCell® infusions
    • Changes in peripheral T lymphocyte counts before the first and subsequent ImmuniCell® infusions (optional)


    Stage 2

    • Efficacy of ImmuniCell®
    • Demonstrate the immune effect resulting from ImmuniCell® treatment
    • Persistence of γδ T cells in the peripheral blood (optional)

    Stage 3

    The secondary outcome measures for this stage of the study will be decided on completion of Stage 2.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Stage 2

    Tumour response, PFS and overall survival will be evaluated at:

    6, 12, 18, 24 36 and 48 weeks after baseline.

    Adverse events and safety blood assessments will be done at each visit.

    Immune response and microRNA analyses will be done at:

    Baseline, then 2, 4, 6, 8, 10 and 12 weeks after baseline.

    Stage 3

    The timepoints for evaluations will be determined after Stage 2 when the study design can be formulated.
    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 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) Yes
    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) 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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    Last Visit of the Last Subject (LVLS)
    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 months4
    E.8.9.1In the Member State concerned days14
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days2
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 26
    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 state54
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 54
    F.4.2.2In the whole clinical trial 54
    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)
    On completion of the study, the participants will return to the routine care of the direct cancer team. At this point, it is not anticipated that further treatment with ImmuniCell® will be available.
    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 Decision2015-08-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-11-27
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