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    Summary
    EudraCT Number:2019-001937-16
    Sponsor's Protocol Code Number:AUTO1-AL1
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2019-11-22
    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 number2019-001937-16
    A.3Full title of the trial
    An Open-Label, Multi-Centre, Phase Ib/II Study Evaluating The Safety and Efficacy Of AUTO1, A CAR T Cell Treatment Targeting CD19, In Adult Patients With Relapsed Or Refractory B Cell Acute Lymphoblastic Leukaemia.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study to evaluate AUTO1 in adults with Acute Lymphoblastic Leukaemia who have previously been treated and subsequently progressed.
    A.4.1Sponsor's protocol code numberAUTO1-AL1
    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 SponsorAutolus Limited
    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 supportAutolus Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAutolus Limited
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street AddressForest House, 58 Wood Lane
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeW12 7RZ
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+1240801 3849
    B.5.6E-mailclinicaltrials@autolus.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 nameAUTO1
    D.3.2Product code AUTO1
    D.3.4Pharmaceutical form Dispersion for 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 INNn/a
    D.3.9.1CAS number n/a
    D.3.9.2Current sponsor codeAUTO1
    D.3.9.3Other descriptive nameAutologous enriched T-cells transduced with a lentiviral vector to express anti-CD19 chimeric antigen receptor
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number10 to 410
    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 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) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms Yes
    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
    Relapsed or refractory B cell acute lymphoblastic leukaemia
    E.1.1.1Medical condition in easily understood language
    Acute lymphoblastic leukaemia. A form of cancer of the white blood cells.
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10000844
    E.1.2Term Acute lymphoblastic leukaemia
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Phase Ib - To evaluate the safety of AUTO1.

    Phase II - To evaluate the clinical efficacy of AUTO1.
    E.2.2Secondary objectives of the trial
    Phase Ib:
    - To evaluate the feasibility of manufacturing and administering AUTO1.
    - To evaluate the clinical efficacy of AUTO1
    - To evaluate the expansion and persistence of AUTO1

    Phase II
    - To evaluate the clinical efficacy of AUTO1
    - To assess the safety and tolerability of AUTO1
    - To evaluate the feasibility of manufacturing and administering AUTO1.
    - To evaluate the expansion and persistence of AUTO1
    - To evaluate the duration of B-cell aplasia
    - To evaluate Patient Reported Outcome and Quality of life assessment
    - To evaluate health care resource utilisation for the management of AUTO1 related toxicity.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age 18 or older.
    2. Eastern cooperative oncology group (ECOG) performance status of 0 or 1.
    3. Relapsed or refractory B-precursor ALL
    4. Patients with Philadelphia chromosome positive ALL (Ph+ ALL) are eligible if they are intolerant to or have failed 2 lines of any tyrosine kinase inhibitor (TKI) or 1 line of second-generation TKI, or if TKI therapy is contraindicated.
    5. Documentation of CD19 expression on leukaemic blasts
    6. Phase Ib:
    Primary Cohort IA: Presence of ≥5% blasts in BM at screening.
    Exploratory Cohort IB: MRD-positive defined as ≥10^-4 and <5% blasts in the BM at screening.
    Phase II:
    Primary Cohort IIA: Presence of ≥5% blasts in BM at screening.
    Exploratory Cohort IIB: MRD-positive defined as ≥10^-4 and <5% blasts in the BM at screening or isolated EM disease with the exception of CNS disease at screening.
    7. Adequate renal, hepatic, pulmonary, and cardiac function.
    E.4Principal exclusion criteria
    1. Phase Ib (Cohort IA and Cohort IB) and Phase II Cohort IIA only: ALL with isolated EM disease.
    2. Diagnosis of Burkitt's leukaemia/lymphoma according to World Health Organization (WHO) classification or chronic myelogenous leukaemia lymphoid blast crisis.
    3. History or presence of clinically relevant CNS pathology.
    4. Presence of CNS-3 disease or CNS-2 disease with neurological changes.
    5. Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management.
    6. Active or latent Hepatitis B virus or active Hepatitis C virus
    7. Human Immunodeficiency Virus (HIV), HTLV-1, HTLV-2, syphilis positive test
    9. Prior CD19 targeted therapy other than blinatumomab. Patients who have experienced Grade 3 or higher neurotoxicity following blinatumomab.
    E.5 End points
    E.5.1Primary end point(s)
    Phase Ib: Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after AUTO1 infusion.

    Phase II: Overall response rate (ORR) defined as proportion of patients achieving complete response [CR] or complete response with incomplete recovery of counts [CRi].
    E.5.1.1Timepoint(s) of evaluation of this end point
    Up to 4 years
    E.5.2Secondary end point(s)
    Phase Ib:
    - Proportion of enrolled patients for whom an AUTO1 product can be manufactured and administered as per protocol.
    - Overall response rate (ORR) defined as proportion of patients achieving complete response [CR] or complete response with incomplete recovery of counts [CRi].
    - Proportion of patients achieving MRD-negative CR
    - Detection of CAR T cells measured in the peripheral blood and bone marrow (BM).

    Phase II:
    - Duration of response (DoR).
    - Relapse Free Survival (RFS).
    - Event Free Survival (EFS).
    - Progression free survival (PFS).
    - Overall Survival (OS).
    - Proportion of patients achieving MRD-negative CR.
    - Incidence of CD19 negative relapse
    - Frequency and severity of adverse events (AEs) and serious adverse events (SAEs).
    - Incidence and duration of severe hypogammaglobulinaemia.
    - Proportion of enrolled patients for whom an AUTO1 product can be manufactured and administered.
    - Detection of CAR T cells measured in the peripheral blood and BM.
    - Depletion of circulating B cells.
    - Changes over time in quality of life scores.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Up to 4 years
    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 Yes
    E.6.7Pharmacodynamic Yes
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    To evaluate further safety.
    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.8.2.4Number of treatment arms in the trial1
    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 concerned7
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA10
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Spain
    United Kingdom
    United States
    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 is expected to be 24 months after the last patient has received AUTO1 infusion.
    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 months3
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days21
    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: 130
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 55
    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 state41
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 56
    F.4.2.2In the whole clinical trial 185
    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)
    Patients will be eligible to be followed up for up to 15 years post AUTO1 infusion on a separate long-term follow-up protocol (AUTO-LT1). Otherwise, they would be treated at their physician's discretion according to local standard of care.
    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 Decision2020-01-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-02-17
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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