Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2021-004287-98
    Sponsor's Protocol Code Number:TCD17197
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2022-01-27
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2021-004287-98
    A.3Full title of the trial
    An open-label, first-in-human, dose-escalation/expansion study of SAR443579 administered as single agent by intravenous infusion in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high risk-myelodysplasia (HR-MDS)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    First-in-human study of SAR443579 infusion in male and female participants of at least 12 years of age with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high risk-myelodysplasia (HR-MDS)
    A.4.1Sponsor's protocol code numberTCD17197
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05086315
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1266-7399
    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 SponsorSanofi-Aventis Recherche & Developpement
    B.1.3.4CountryFrance
    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 supportSanofi-Aventis Recherche & Developpement
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSanofi B.V.
    B.5.2Functional name of contact pointTeam Manager
    B.5.3 Address:
    B.5.3.1Street AddressPaasheuvelweg 25
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 BP
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031202454000
    B.5.5Fax number0031202453952
    B.5.6E-mailstartup.nl@sanofi.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.3.2Product code SAR443579
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfusion (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNNA
    D.3.9.2Current sponsor codeSAR443579
    D.3.9.4EV Substance CodeSUB237071
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    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 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 Yes
    D.3.11.13.1Other medicinal product typeSAR443579 is a humanized IgG1 monoclonal antibody
    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 acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high risk-myelodysplasia (HR-MDS)
    E.1.1.1Medical condition in easily understood language
    Relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high risk-myelodysplasia (HR-MDS)
    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 PT
    E.1.2Classification code 10003917
    E.1.2Term B-cell type acute leukaemia
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10081513
    E.1.2Term Acute myeloid leukaemia refractory
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10028533
    E.1.2Term Myelodysplastic syndrome
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Dose Escalation Part: To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) of SAR443579 administered as a single agent in patients with relapsed or refractory acute myeloid leukemia (R/R AML), high risk-myelodysplastic syndrome (HR-MDS), or B-cell acute lymphoblastic leukemia (B-ALL)

    Dose Expansion Part: To assess the anti-leukemic activity of SAR443579 administered as of single agent at the confirmed recommended Phase 2 dose (RP2D) in patients with R/R AML
    E.2.2Secondary objectives of the trial
    To select the preliminary RP2D (pRP2D) (Escalation Part) and confirm RP2D (Expansion Part)

    To characterize the overall safety and tolerability profile of SAR443579 (Escalation and Expansion Parts)

    To characterize the PK profile of SAR443579 when administered as a single agent (Escalation and Expansion Parts)

    To evaluate the potential immunogenicity of SAR443579 (Escalation and Expansion Parts)

    To assess preliminary evidence of hematologic response (Escalation Part)

    To assess alternative CR rate (Expansion Part)

    To assess overall complete remission rate (Expansion Part)

    To assess duration of Response (DoR) (Expansion Part)

    To assess duration of event-free survival (EFS) (Expansion Part)

    To assess survival rate (Expansion Part)

    To assess the rate of hematopoietic stem cell transplantation (HSCT) (Expansion Phase)

    To assess time to treatment failure (TTF) for participants who did no experience complete remission
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Participant must be ≥12 years old at the time the trial participant or legal guardian signs the informed consent form.
    For participants of the Escalation Part only:
    - Confirmed diagnosis of primary or secondary AML [any subtype except acute promyelocytic leukemia (APL)] according to World Health Organization (WHO) classification. Patients with AML must meet one of the following criteria, a), b) or c) and are limited to those with no available (or are ineligible) therapy with known clinical benefit.
    a) Primary Induction Failure (PIF) AML, defined as disease refractory to one of the following, i or ii.
    i) An intensive induction attempt, per institution. Induction attempts include high-dose and/or standard-dose cytarabine ± an anthracyclines/anthracenedione ± an anti-metabolite, with or without growth factor or targeted therapy containing regimens.
    Examples include but are not limited to:
    -- One cycle of high dose cytarabine (HiDAC) containing regimen
    -- One cycle of liposomal cytarabine and daunorubicin
    -- Two cycles of standard dose cytarabine containing regimen
    ii) For adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy; PIF is defined as AML refractory to one of the following less intensive regimens, 1 or 2:
    1. 4 cycles of hypomethylating agents (HMA) or
    2. 2 cycles HMA + venetoclax
    b) Early relapse (ER) AML, defined as AML in relapse with CR duration < 6 months from most recent treatment
    c) Leukemia in first or higher relapse
    - Confirmed diagnosis of cluster of differentiation 123 (CD123) + HR-MDS, with a Revised International Prognostic Scoring System (IPSS-R) risk category of intermediate or higher and are limited to those with no available (or are ineligible) therapy with known clinical benefit.
    -- Not eligible for induction therapy and having completed ≥2 cycles of any of the following: hypomethylating agent (eg, 5 azacitidine or decitabine) and/or venetoclax, chemotherapy, or targeted agents.
    -- Not eligible for autologous stem cell transplant (ASCT) and having completed ≥1 course of induction therapy.
    - Confirmed diagnosis of CD123 + B-ALL without extramedullary lesions that have no available (or are ineligible) therapy with known clinical benefit.
    For Participants in the Expansion Part Only:
    - For participants in Cohort A: Participants meeting inclusion criteria for AML patients that have been primary refractory (PIF) to prior induction treatment or who have had ER occurring 6 months or less after an initial remission on prior induction treatment.
    - For participants in Cohort B: Participants meeting inclusion criteria for AML patients that have had late relapse (LR), occurring more than 6 months after an initial remission on prior induction treatment.
    - Body weight >40 kg.
    E.4Principal exclusion criteria
    - Eastern Cooperative Oncology Group (ECOG) performance status >2 (≥18 years-old). Karnovsky Scale (16-17 years-old) <50% or Lansky Scale (<16 years-old) <50%.
    - Ongoing or recent (within 5 years) evidence of significant autoimmune
    disease that requires or required treatment with systemic
    immunosuppressive treatments, which may suggest a risk for immunerelated
    adverse events. The following are not exclusionary: vitiligo,
    childhood asthma that has resolved, residual hypothyroidism that
    required only hormone replacement or psoriasis that does not require
    systemic treatment.
    - History of an invasive malignancy that requires active therapy
    (adjuvant hormonal therapy is allowed) other than the one treated in
    this study, with the exception of resected/ablated basal or squamouscell
    carcinoma of the skin or carcinoma in situ of the cervix, or other
    local tumors considered cured by local treatment.
    - Evidence of active central nervous system leukemia at the time of enrollment as evidenced by cytology or pathology.
    - Known acquired immunodeficiency syndrome (AIDS-related illnesses)
    or human immunodeficiency virus (HIV) disease requiring antiretroviral
    treatment, or having active hepatitis B or C infection, or severe acute
    respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.
    - Prior treatment with an anti-CD123-directed agent.
    - Prior HSCT with relapse beyond 3 months or prior CAR-T therapy in BALL
    with relapse beyond 2 months may be included only if off
    immunosuppression for a minimum of 4 weeks and no evidence of GVHD.
    - Receiving at the time of first investigational medicinal product (IMP) administration corticosteroid as a concomitant medication with corticosteroid dose > 10 mg/day of oral prednisone or equivalent.
    - AML or HR-MDS participants with prior treatment with cellular therapy,
    eg, chimeric antigen receptor T cell (CAR-T) or chimeric antigen receptor
    NK cell (CAR-NK). Prior CAR-T therapy is allowed for participants with BALL.
    - Concurrent treatment with other investigational drugs.
    - Radiotherapy, even if palliative in intent, may not be given during the study.
    - Prophylactic use of hematopoietic growth factors (eg, granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), erythropoietin) during the DLT observation period in the Dose Escalation Part only.
    - Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
    - Pregnant and breast-feeding women.
    - History of solid organ transplant, including corneal transplant.
    - Average QTc (using the Fridericia correction calculation) >470 millisecond (msec) at screening.
    E.5 End points
    E.5.1Primary end point(s)
    1 - Incidence of dose-limiting toxicity (DLT) (Escalation Part)
    2 - Proportion of participants who have a CR (Complete Remission) + CRi (Complete Remission with Incomplete Hematological Recovery) (Expansion Part)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1 - Day 1 to Day 28
    2 - Up to 6 months
    E.5.2Secondary end point(s)
    1 - Recommended Phase 2 dose (RP2D)
    2 - Number of participants with treatment-emergent adverse events (TEAEs) (Escalation and Expansion Parts)
    3 - Cmax: Maximum observed concentration
    4 - AUC0-T: Area under the concentration versus time curve calculated using the trapezoidal method during a dosing interval (T)
    5 - Incidence of anti-drug antibody (ADA) (Escalation and Expansion Parts)
    6 - Anti-leukemic activity as define by International Working Group (IWG) for AML (modified) and MDS, or NCCN for B-ALL (Escalation Part)
    7 - Proportion of participants with CR + CRh (complete remission with partial hematological recovery) (Expansion Part)
    8 - Rate of CR + CRh + CRi + MLFS (morphological leukemia-free state) (Expansion Part)
    9 - Time interval from first documented evidence of CR until progressive disease (PD) as per modified IWG or death due to any cause, whichever comes first (Expansion Part)
    10 - Time interval from date of first SAR443579 administration to induction failure, relapse or death due to any cause, whichever comes first (Expansion Part)
    11 - Proportion of survivors from the first SAR443579 administration to death from any cause (Expansion Part)
    12 - Rate of HSCT through SAR443579 treatment but before subsequent therapy (Expansion Part)
    13 - Time from first SAR443579 administration to discontinuation for any reason excluding remission, ie, disease progression, treatment toxicity, patient preference or death (Expansion Part)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 11 - Up to 12 months
    2, 5, 9, 10, 12, 13 - Up to 30 months
    3, 4 - Day 1 to end of trial (maximum up to 30 months)
    6, 7, 8 - Up to 6 months
    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 Yes
    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) 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA7
    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
    Australia
    United States
    France
    Netherlands
    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
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 10
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 10
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 36
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 57
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 29
    F.4.2.2In the whole clinical trial 103
    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
    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 Decision2022-01-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-03-16
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sat May 04 19:55:16 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA