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    Summary
    EudraCT Number:2021-002333-42
    Sponsor's Protocol Code Number:OC-01-21001
    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:2022-07-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2021-002333-42
    A.3Full title of the trial
    Safety and efficacy of hCD1a-CAR T (OC-1) therapy, in patients with relapsed/refractory (R/R) T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LL)
    Seguridad y eficacia de la terapia hCD1a-CAR T (OC-1), en pacientes con leucemia/linfoma linfoblástico agudo de células T (T-ALL/LL) en recaída/refractario (R/R)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Safety and Efficacy of OC-1 Cell Therapy in Patients With Relapsed or Refractory T-Cell Acute Lymphoblastic Leukemia or Lymphoma
    Seguridad y eficacia de la terapia de células OC-1 en pacientes con leucemia o linfoma linfoblástico agudo de células T en recaída o refractario
    A.3.2Name or abbreviated title of the trial where available
    CARxALL
    CARxALL
    A.4.1Sponsor's protocol code numberOC-01-21001
    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 SponsorOneChain Immunotherapeutics
    B.1.3.4CountrySpain
    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 supportOneChain Immunotherapeutics
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOneChain Immunotherapeutics
    B.5.2Functional name of contact pointResearch Project Management
    B.5.3 Address:
    B.5.3.1Street Addressc/ Muntaner 383, 3º2ª
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08021
    B.5.3.4CountrySpain
    B.5.6E-mailwilmar@onechaintx.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 numberEU/3/21/2535
    D.3 Description of the IMP
    D.3.1Product nameOC-1
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravascular use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOC-1
    D.3.9.2Current sponsor codeOC-1
    D.3.9.3Other descriptive nameAutologous T cells ex vivo modified with a lentiviral vector encoding a chimeric antigen receptor specific for CD1a
    D.3.9.4EV Substance CodeSUB222192
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number0.5 to 5
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Children older than 2 years or adults, male and female, with refractory or relapsed T-cell acute lymphoblastic leukaemia/lymphoblastic lymphoma (T-ALL/LL).
    Niños mayores de 2 años o adultos, hombres y mujeres, con leucemia linfoblástica aguda de células T/linfoma linfoblástico (T-ALL/LL) refractario o recidivante.
    E.1.1.1Medical condition in easily understood language
    Lymphoblastic leukaemia / Lymphoblastic lymphoma
    Leucemia linfoblástica aguda / Linfoma linfoblástico
    E.1.1.2Therapeutic area Diseases [C] - Blood and lymphatic diseases [C15]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10036546
    E.1.2Term Precursor T-lymphoblastic lymphoma/leukaemia recurrent
    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 assess the safety of OC-1 in patients with primary relapsed/refractory CD1a-positive T-ALL/LL.
    Evaluar la seguridad de OC-1 en pacientes con T-ALL/LL CD1a-positivo primario recidivante/refractario.
    E.2.2Secondary objectives of the trial
    Other key objectives are to assess the preliminary efficacy and persistence of the product:
    - To describe the response to OC-1.
    - To describe the duration of the response after the administration of OC-1.
    - To describe the overall survival after the administration of OC-1.
    - To describe the persistence of OC-1 cells in peripheral blood after administration.
    Otros objetivos clave son evaluar la eficacia preliminar y la persistencia del producto:
    - Describir la respuesta a OC-1.
    - Describir la duración de la respuesta tras la administración de OC-1.
    - Describir la supervivencia global tras la administración de OC-1.
    - Describir la persistencia de las células OC-1 en sangre periférica tras su administración.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Children older than 2 years or adults, male and female in both groups.

    2.Patients CD1a positive antigen blast expression ≥20%, either immunophenotypically (flow cytometry) or histologically confirmed.

    3.R/R CD1a-positive T-ALL/LL patients, including morphologic or MRD-detectable (≥1x10-4) bone marrow and/or extramedullary relapses after 2 therapy lines:
    ­-Relapse after allogeneic haematopoietic stem cell transplantation (allo-HSCT)
    ­-Primary refractoriness, defined as either morphologic persistence or detectable MRD (≥1x10-4) after two standard therapy lines, making the patient not candidate for allo-HSCT.
    ­-Refractory first relapse.
    ­-Second or further relapse.

    4.Patient without reproductive capacity or else, commitment to the use of a highly effective method of contraception during the study.
    1.Niños mayores de 2 años o adultos, hombres y mujeres en ambos grupos.

    2.Pacientes con expresión blástica del antígeno CD1a ≥20 %, ya sea inmunofenotípicamente (citometría de flujo) o confirmada histológicamente.

    3.Pacientes R/R CD1a positivos para T-ALL/LL, incluidas recaídas extramedulares y/o de médula ósea morfológicas o detectables por EMR (≥1x10-4) después de 2 líneas de terapia:
    -Recaída tras trasplante alogénico de progenitores hematopoyéticos (alo-TPH)
    -La refractariedad primaria, definida como persistencia morfológica o MRD detectable (≥1x10-4) después de dos líneas de terapia estándar, hace que el paciente no sea candidato para alo-HSCT.
    -Primera recaída refractaria.
    -Segunda o más recaídas.

    4.Paciente sin capacidad reproductiva o bien, compromiso con el uso de un método anticonceptivo de alta eficacia durante el estudio.
    E.4Principal exclusion criteria
    1.Limiting organ dysfunction, such as uncontrolled cardiac (e.g., depressed left ventricular ejection fraction (LVEF), <45%), pulmonary, liver, renal or CNS dysfunction.

    2.Allo-HSCT within a time frame <3 months, or requiring continued immunosuppressive treatment for graft versus host disease (GvHD).

    3.Uncontrolled epilepsy or underlying central nervous system (CNS) severe disease.

    4.Active bacterial, fungal or viral infection not controlled by adequate treatment.

    5.Known HIV, active hepatitis B (HBV), or hepatitis C virus (HCV) infection.

    6.Women who are pregnant (urine/blood pregnancy test positive) or lactating.

    7.Severe illness or medical condition, which would not permit the patient to be managed according to the protocol.

    8.Suffering from a serious autoimmune disease or immunodeficiency disease.

    9.The patient participated in other experimental drug clinical trial within 6 weeks prior to enrollment.

    10.Other non-controlled concomitant neoplasms.
    1.Disfunción orgánica limitante, como disfunción cardíaca no controlada (p. ej., fracción de eyección del ventrículo izquierdo (FEVI) deprimida, <45 %), disfunción pulmonar, hepática, renal o del SNC.

    2.Alo-HSCT dentro de un marco de tiempo <3 meses, o que requiere tratamiento inmunosupresor continuo para la enfermedad de injerto contra huésped (GvHD).

    3.Epilepsia no controlada o enfermedad grave subyacente del sistema nervioso central (SNC).

    4.Infección bacteriana, fúngica o vírica activa no controlada
    con un tratamiento adecuado.

    5.Infección conocida por el VIH, la hepatitis B activa (VHB) o el virus de la hepatitis C (VHC).

    6.Mujeres embarazadas (prueba de embarazo en orina/sangre positiva) o lactantes.

    7.Enfermedad o condición médica grave, que no permitiría manejar al paciente de acuerdo con el protocolo.

    8.Padecer una enfermedad autoinmune grave o una enfermedad de inmunodeficiencia.

    9.El paciente participó en otro ensayo clínico de fármaco
    experimental dentro de las 6 semanas anteriores a la
    inscripción.

    10.Otras neoplasias concomitantes no controladas.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the infusion of OC-1 safety on the basis of the following parameters:
    •Number of adverse events grade III-IV using Common Toxicity Criteria for Adverse Events (CTCAE) version 5.
    •Incidence of severe Cytokine release syndrome (CRS) ≥ grade III and Immune effector cell-associated neurotoxicity syndrome (ICANS) ≥ grade II
    •Proportion of patients with non-relapse, treatment-related mortality (NRM)
    •Number of adverse events of special interest (AESI).
    •Assessment of the immunological homeostasis, through the description of lymphocytes subpopulations at each study timepoint.
    •Incidence of severe (≥3) treatment-related dermatological events.
    •Number of patients developing dose limiting toxicity (DLT).
    Evaluar la seguridad de la infusión de OC-1 en base a los siguientes parámetros:
    •Número de eventos adversos grado III-IV utilizando los Criterios de Toxicidad Común para Eventos Adversos (CTCAE) versión 5.
    •Incidencia de síndrome de liberación de citoquinas (CRS) grave ≥ grado III y síndrome de neurotoxicidad asociado a células efectoras inmunitarias (ICANS) ≥ grado II
    •Proporción de pacientes sin recaída, mortalidad relacionada con el tratamiento (NRM)
    •Número de eventos adversos de especial interés (AESI).
    •Evaluación de la homeostasis inmunológica, mediante la descripción de las subpoblaciones de linfocitos en cada momento del estudio.
    •Incidencia de eventos dermatológicos graves (≥3) relacionados con el tratamiento.
    •Número de pacientes que desarrollaron toxicidad limitante de la dosis (DLT).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study
    A lo largo del estudio
    E.5.2Secondary end point(s)
    •Remission rate: Percentage of patients presenting complete response (CR) or incomplete count recovery (CRi) at any point after treatment.
    •Duration of remission: The duration of the remission will be assessed from the first documented date of remission status until progression (in days)
    •Minimal residual disease (MRD) response by flow cytometry: blast count among patients presenting bone marrow complete response (sensitivity 10-4).
    •Progression-free survival: time since the first infusion to the documented loss of response. In patients not presenting a CR or CRi progression free survival will be zero.
    •Overall survival time since first infusion to date of death.
    •Persistence of OC-1, as determined by flow cytometry and quantitative analysis by qPCR.
    •Tasa de remisión: Porcentaje de pacientes que presentan respuesta completa (RC) o recuperación incompleta del conteo (RCi) en cualquier momento después del tratamiento.
    •Duración de la remisión: La duración de la remisión se evaluará desde la primera fecha documentada del estado de remisión hasta la progresión (en días)
    •Respuesta de la enfermedad residual mínima (MRD) por citometría de flujo: recuento de blastos entre los pacientes que presentan una respuesta completa de la médula ósea (sensibilidad 10-4).
    •Supervivencia libre de progresión: tiempo desde la primera infusión hasta la pérdida de respuesta documentada. En pacientes que no presenten RC o RCi la supervivencia libre de progresión será nula.
    •Tiempo de supervivencia global desde la primera infusión hasta la fecha de la muerte.
    •Persistencia de OC-1, determinada por citometría de flujo y análisis cuantitativo por qPCR.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the study
    A lo largo del estudio
    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) Yes
    E.7.1.1First administration to humans Yes
    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) No
    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.8.2.4Number of treatment arms in the trial0
    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 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 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
    Última visita último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    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 Yes
    F.1.1Number of subjects for this age range: 12
    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: 6
    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) Yes
    F.1.2.1Number of subjects for this age range: 6
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 6
    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 state24
    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 esperado de la enfermedad
    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 Decision2022-11-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-09-30
    P. End of Trial
    P.End of Trial StatusOngoing
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