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    EudraCT Number:2019-001263-70
    Sponsor's Protocol Code Number:IIBSP-CAR-2019-30
    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
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2019-001263-70
    A.3Full title of the trial
    Immunotherapy with differential, adult, autologous, peripheral blood cells, expanded and transduced (genetically modified) using a lentiviral vector to express a chimeric receptor with anti-CD30 specificity associated with costimulatory sequences 4-1-BB and CD3z in patients with Classical Hodgkin's lymphoma and non-Hodgkin's lymphoma T with CD30 expression
    Inmunoterapia con linfocitos T diferenciados, adultos, autólogos, de sangre periférica, expandidos y transducidos (modificados genéticamente) mediante un vector lentiviral para que expresen un receptor quimérico con especificidad anti-CD30 asociado a secuencias coestimuladoras 4-1-BB y CD3z en pacientes con linfoma de Hodgkin clásico y linfoma no-hodgkin T con expresión CD30
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Immunotherapy with differentiated T lymphocytes genetically modified in patients with classic Hodgkin's lymphoma and non-Hodgkin's lymphoma T with CD30 expression
    Inmunoterapia con linfocitos T diferenciados modificados genéticamente en pacientes con linfoma de Hodgkin clásico y linfoma no-hodgkin T con expresión CD30
    A.4.1Sponsor's protocol code numberIIBSP-CAR-2019-30
    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 SponsorInstitut de Recerca H. de la Santa Creu i Sant Pau
    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 supportInstitut de Recerca H. de la Santa Creu i Sant Pau
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca H. de la Santa Creu i Sant Pau
    B.5.2Functional name of contact pointUICEC Sant Pau
    B.5.3 Address:
    B.5.3.1Street AddressSant Quintí 77-79
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08041
    B.5.4Telephone number+34935537636
    B.5.5Fax number+34935537864
    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.3.2Product code Linfocitos HSP-CAR30
    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 INNLinfocitos HSP-CAR30
    D.3.9.2Current sponsor codeLinfocitos HSP-CAR30
    D.3.9.3Other descriptive nameAUTOLOGOUS T-LYMPHOCYTES
    D.3.9.4EV Substance CodeSUB96123
    D.3.10 Strength
    D.3.10.1Concentration unit Munit million units
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number3 to 10
    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. cell therapy medicinal product No
    D. therapy medical product Yes
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 Yes
    D. medicinal product typeAutologous T cells genetically modified ex vivo using a lentiviral vector encoding an anti-CD30 chimeric antigen receptor (CAR)
    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
    Classic Hodgkin lymphoma and T-cell lymphoma with CD30 expression
    Linfoma de Hodgkin clásico y linfoma T con expresión CD30
    E.1.1.1Medical condition in easily understood language
    Classic Hodgkin lymphoma and T-cell lymphoma with CD30 expression
    Linfoma de Hodgkin clásico y linfoma T con expresión CD30
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    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 evaluate the safety and toxicity of the administration of autologous, mature, ex vivo expanded and genetically modified T lymphocytes with a chimeric antigen-specific receptor (CAR) directed against the CD30 antigen.
    Evaluar la seguridad y toxicidad de la administración de linfocitos T autólogos, maduros, expandidos ex vivo y modificados genéticamente con un receptor quimérico antígeno-específico (CAR) dirigido frente al antígeno CD30.
    E.2.2Secondary objectives of the trial
    - Analyze the implant and persistence of T-CAR30 cells.
    - Analyze the rate of complete answers at 3 months of the procedure, using PET-CT.
    - Analyze the impact of the procedure on 1-year progression-free survival.
    - Analizar el implante y persistencia de las células T-CAR30.
    - Analizar la tasa de respuestas completas a los 3 meses del procedimiento, mediante PET-TC.
    - Analizar el impacto del procedimiento en la supervivencia libre de progresión a 1 año.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with classic Hodgkin's disease:
    - Age between 18-70 years inclusive.
    - Patients in relapse after an autologous hemopoietic stem cell transplant and who have previously received brentuximab and anti-PDL1 antibodies in some of the rescue treatments, without reaching RC.
    - Patients who are primarily refractory (after the 1st line of treatment) and who do not reach RC after rescue treatments that include brentuximab and anti-PDL1 antibodies.

    Patients with anaplastic large cell lymphoma T (ALK + and ALK -) and peripheral T lymphoma (NOS and angioimmunoblastic):
    - Expression of CD30 (determined by immunohistochemistry) in> 90% of tumor cells for peripheral T-lymphoma.
    - Age between 18-70 years inclusive.
    - Patients in relapse after an autologous hemopoietic stem cell transplant.
    - Patients who are primarily refractory (after the 1st line of treatment that includes anthracycline) who do not achieve CR after rescue chemotherapy (ESHAP, ICE, DHAP, Gemex, or brentuximab vedotin).
    Pacientes con enfermedad de Hodgkin clásico:
    - Edad entre 18-70 años inclusive.
    - Pacientes en recidiva tras un trasplante autólogo de progenitores hemopoyéticos y que hayan recibido previamente brentuximab y anticuerpos anti-PDL1 en alguno de los tratamientos de rescate, sin alcanzar RC.
    - Pacientes primariamente refractarios (tras 1ª línea de tratamiento) y que no alcancen RC tras tratamientos de rescate que incluyan brentuximab y anticuerpos anti-PDL1.

    Pacientes con linfoma T anaplásico de célula grande (ALK + y ALK -) y linfoma T periférico (NOS y angioinmunoblástico):
    - Expresión de CD30 (determinado por inmunohistoquímica) en > 90% de las células tumorales para el linfoma T periférico.
    - Edad entre 18-70 años inclusive.
    - Pacientes en recidiva tras un trasplante autólogo de progenitores hemopoyéticos.
    - Pacientes primariamente refractarios (tras 1ª línea de tratamiento que incluya antraciclina) que no alcancen una RC tras quimioterapia de rescate (tipo ESHAP, ICE, DHAP, Gemex, o brentuximab vedotina).
    E.4Principal exclusion criteria
    - General condition determined according to the ECOG scale: 2-4
    - Previous allogeneic hemopoietic transplant
    - Active infection by HBV or HCV.
    - HIV infection.
    - Bacterial, fungal or viral active infection.
    - Active infiltration of the CNS by lymphoma. Previous infiltration by lymphoma is not exclusive if there is evidence of absence of disease in the CNS prior to treatment.
    - Abnormal renal and hepatic functions, with a creatinine and / or bilirubin figure 2 and 3 times higher than the normal limit value, respectively, except when the alterations are attributable to the lymphoma (only in case of hepatic alliteration).
    - Patients with decreased ejection fraction (less than 45%), symptomatic heart failure, or both.
    - Presence of cirrhosis or active hepatitis due to HBV or HCV virus.
    - Patients with concomitant severe neurological or psychiatric disease.
    - Presence of active autoimmune or rheumatological disease that requires systemic treatment with any immunosuppressant (including prednisone at any dose).
    - Pneumopathy of any kind that conditions a DLC <50%
    - Major surgery in the 6 weeks prior to the start of inclusion.
    - Any concomitant antineoplastic treatment.
    - Pregnancy.
    - Estado general determinado según escala ECOG: 2-4
    - Trasplante hemopoyético alogénico previo
    - Infección activa por VHB ó VHC.
    - Infección por VIH.
    - Infección bacteriana, fúngica o vírica activa.
    - Infiltración activa del SNC por linfoma. La infiltración previa por linfoma no es excluyente si existe demostración de ausencia de enfermedad en el SNC previa al tratamiento.
    - Funciones renal y hepática anormales, con cifra de creatinina y/o bilirrubina 2 y 3 veces superior al valor límite normal, respectivamente, excepto cuando las alteraciones sean atribuibles al linfoma (solo en caso de la aliteración hepática).
    - Pacientes con fracción de eyección disminuida (inferior al 45%), insuficiencia cardiaca sintomática, o ambas.
    - Presencia de cirrosis o hepatitis activa por virus VHB o VHC.
    - Pacientes con enfermedad neurológica o psiquiátrica grave concomitante.
    - Presencia de enfermedad autoinmune ó reumatológica activa que requiera tratamiento sistémico con cualquier inmunosupresor (incluido prednisona a cualquier dosis).
    - Neumopatía de cualquier tipo que condiciones una DLC < 50%
    - Cirugía mayor en las 6 semanas previas al inicio de la inclusión.
    - Cualquier tratamiento antineoplásico concomitante.
    - Pacientes embarazadas.
    E.5 End points
    E.5.1Primary end point(s)
    -Dose-limiting dose
    -Toxicidad limitante de dosis
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time to event
    Hasta que ocurra
    E.5.2Secondary end point(s)
    -Implant and persistence of HSP-CAR30 cells.
    -Free progression survival.
    -Global survival
    -Implante y persistencia de células HSP-CAR30.
    -Supervivencia libre de progresión.
    -Supervivencia global
    E.5.2.1Timepoint(s) of evaluation of this end point
    Time to event
    Hasta que ocurra
    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) Yes
    E.7.1.1First administration to humans Yes
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. 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 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
    Ultima visita del último paciente incluido
    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 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: 25
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state30
    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)
    Expected normal treatment of the condition
    Tratamiento habitual de la patología
    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 Decision2020-03-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-09
    P. End of Trial
    P.End of Trial StatusOngoing
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