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    Summary
    EudraCT Number:2012-005498-29
    Sponsor's Protocol Code Number:2.28
    National Competent Authority:Slovenia - JAZMP
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2013-03-01
    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 ConcernedSlovenia - JAZMP
    A.2EudraCT number2012-005498-29
    A.3Full title of the trial
    Preparation and application of autologous immunohybridoma cells for the treatment of prostate cancer
    Priprava in uporaba avtolognih imunohibridomov za zdravljenje karcinoma prostate
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunotherapy for the treatment of prostate cancer
    Imunoterapija za zdravljenje karcinoma prostate
    A.4.1Sponsor's protocol code number2.28
    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 SponsorCelica, Biomedical Center, d.o.o.
    B.1.3.4CountrySlovenia
    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 supportCelica, Biomedical Center, d.o.o.
    B.4.2CountrySlovenia
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelica, Biomedical Center, d.o.o.
    B.5.2Functional name of contact pointCelica, Biomedical Center, d.o.o.
    B.5.3 Address:
    B.5.3.1Street AddressTehnološki park 24
    B.5.3.2Town/ cityLjubljana
    B.5.3.3Post code1000
    B.5.3.4CountrySlovenia
    B.5.4Telephone number386(0)1544 36 04
    B.5.5Fax number386(0)1544 36 05
    B.5.6E-mailrobert.zorec@celica.si
    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 nameHybriCure
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Yes
    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) Yes
    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
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Prostate cancer
    Karcinom prostate
    E.1.1.1Medical condition in easily understood language
    Prostate cancer
    Rak prostate
    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 assess safety, practicability, tolerability and non-toxicity of the treatment with autologous immunohybridoma cells and the effect on the quality of live of the patients with prostate cancer
    Oceniti varnost, izvedljivost, tolerabilnost in ne-toksičnost zdravljenja z avtolognimi imunohibridomi ter vpliv na kvaliteto življenja pacientov s karcinomom prostate
    E.2.2Secondary objectives of the trial
    To asses the type and the extend of the clinical outcome of the treatment with autologous immunohybridoma cells and to evaluate the effect on the overall survival of the patient with prostate cancer
    Oceniti vrsto in obseg kliničnih odzivov na zdravljenje z avtolognimi imunohibridomi ter vpliv na celokupno preživetje bolnika z rakom prostate
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically proven prostate cancer in a progressive stage of disease despite castrate levels of testosterone
    • Men of 18 years of age or older, who have signed an informed consent to participate in the trial
    • Life expectancy at least 12 months (ECOG performance status 0-1)
    • Positive DTH response on historical antigens
    • Laboratory values as outlined in the protocol
    • Histološko dokazan karcinom prostate v progresivnem stanju bolezni kljub kastracijskim vrednostim testosterona
    • Moški stari 18 let in več, ki so podpisali pisni pristanek na sodelovanje v klinični raziskavi
    • Pričakovano preživetje najmanj 12 mesecev (bolnik mora imeti ECOG telesno zmogljivost 0-1)
    • Pozitivni DTH odziv na standardne historične antigene
    • Laboratorijske vrednosti kot je navedeno v protokolu
    E.4Principal exclusion criteria
    • Active metastasis in the central nervous system
    • Active infectious diseases that would require antibiotic or antivirus therapy
    • Patients suffering from severe pain that would require chronic opioid analgesic therapy
    • Patients who are HIV+, HBV+, or HCV+
    • Serious intercurrent medically uncontrolled illness
    • Intercurrent secondary malignant neoplasm
    • Clinically significant vasculitis or other autoimmune disease
    • Alcohol addiction or addiction to other drugs
    • Psychiatric disorders that could affect the study
    • Patients that received immunomodulatory therapy within 30 days prior to the initiation of the study
    • Previous radiation therapy for prostate cancer
    • Previous radical operative treatment of prostate
    • Previous severe radiation therapy for lymph nodes
    • Hydroxyurea treatment within 45 days prior to the initiation of the study
    • Signs of toxicity of the previous therapies
    • Patients treated with more than one chemotherapy cycle
    • The last chemotherapy treatment less than 4 weeks prior to the initiation of the study
    • Previous autologous or alogenic anti-tumor vaccine
    • Intercurrent immune therapy or chemotherapy
    • Corticosteroid treatment or other treatments of adrenal insufficiency within 2 weeks prior to the initiation of the study (hormonal therapy for the maintenance of the castrate levels of testosterone is allowed)
    • Aktivne metastaze v centralnem živčnem sistemu
    • Aktivne infekcijske bolezni, ki bi zahtevale antibiotično ali protivirusno terapijo
    • Bolniki s hudimi bolečinami, ki bi zahtevale kronično opioidno analgezijo
    • Bolniki okuženi s HIV, HBV ali HCV
    • Vzporedna hujša medicinsko neobvladljiva bolezen
    • Vzporedno sekundarno maligno obolenje
    • Vaskulitis ali druga avtoimuna obolenja
    • Alkoholna odvisnost ali odvisnosti od drugih drog
    • Psihiatrične bolezni, ki bi lahko vplivale na študijo
    • Pacienti, ki so prejeli imunomodulatorno terapijo znotraj 30 dni od začetka študije
    • Predhodna radioterapija prostate
    • Predhodna radikalna operativna terapija postate
    • Predhodno obsežno obsevanja bezgavk
    • Uporaba hidroksiuree v zadnjih 45 dneh od začetka študije
    • Znaki toksičnosti predhodne terapije
    • Pacient zdravljen z več kot enim kemoterapevtskim ciklom
    • Zadnja kemoterapija pred manj kot 4 tedni pred pričetkom študije
    • Predhodna avtologna ali alogena protitumorska vakcinacija
    • Vzporedno prejemanje imunske terapije ali kemoterapije
    • Terapija s kortikosteroidi ali drugimi preparati za zdravljenje adrenalne insuficience v zadnjih 2 tednih pred pričetkom študije (hormonska terapija za vzdrževanje kastracijske vrednosti testosterone je dovoljena)
    E.5 End points
    E.5.1Primary end point(s)
    To assess safety, practicability, tolerability and non-toxicity of the treatment with autologous immunohybridoma cells and the effect on the quality of live of the patients with prostate cancer
    Oceniti varnost, izvedljivost, prenosljivost in ne-toksičnost zdravljenja z avtolognimi imunohibridomi ter vpliv na kvaliteto življenja pacientov s karcinomom prostate
    E.5.1.1Timepoint(s) of evaluation of this end point
    6 months from the initiation of the study for each patient
    6 mesecev od začetka študije za vsakega pacienta
    E.5.2Secondary end point(s)
    To determine if cellular immunity is induced by consecutive vaccinations with autologous immunohybridoma cells in prostate cancer patients.

    To determine if vaccination with autologous immunohybridoma cells results in clinically measurable disease responses.
    Ugotoviti, ali zaporedne vakcinacije z imunohibridomi povzročijo celični imunski odziv pri bolnikih s karcinomom prostate.

    Ugotoviti, ali zaporedne vakcinacije z imunohibridomi povzročijo klinično zaznavne odzive.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 year from the initiation of the study for each patient
    1 leto od začetka študije za vsakega pacienta
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    LVLS
    Zadnji obisk zadnjega pacienta
    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 No
    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) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 2
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 18
    F.2 Gender
    F.2.1Female No
    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 state20
    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)
    None
    Nobenih
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Blood Transfusion Centre of Slovenia
    G.4.3.4Network Country Slovenia
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2013-03-21
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-04-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-11-08
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