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    Summary
    EudraCT Number:2022-002440-40
    Sponsor's Protocol Code Number:TX200-KT03
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-12-20
    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 ConcernedGermany - PEI
    A.2EudraCT number2022-002440-40
    A.3Full title of the trial
    Long-Term Follow-Up of Patients who have received an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (CAR- Treg therapy, TX200-TR101) in a prior clinical study.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Long-Term Follow-Up of Patients who have received an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (CAR- Treg therapy, TX200-TR101) in a prior clinical study.
    A.3.2Name or abbreviated title of the trial where available
    Long-Term Follow-Up of TX200-TR101 (STEADFAST Long Term)
    A.4.1Sponsor's protocol code numberTX200-KT03
    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 SponsorSangamo Therapeutics France SAS
    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 supportSangamo Therapeutics France SAS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSangamo Therapeutics France SAS
    B.5.2Functional name of contact pointTX200-KT03 Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressLes Cardoulines HT1, Allée de la Nertière
    B.5.3.2Town/ cityValbonne
    B.5.3.3Post code06560
    B.5.3.4CountryFrance
    B.5.6E-mailsmb-tx200-kt03@sangamo.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/3/22/2647 EMA/0D/0000078610
    D.3 Description of the IMP
    D.3.1Product nameAutologous HLA-A2 Chimeric Antigen Receptor T regulatory cells
    D.3.2Product code TX200-TR101
    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 INNNot yet assigned
    D.3.9.2Current sponsor codeTX200-TR101
    D.3.9.3Other descriptive nameAutologous naive regulatory T cells transduced with a lentiviral vector encoding for a chimeric antigen receptor to recognise the HLA-A*02 antigen
    D.3.9.4EV Substance CodeSUB201165
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25E+06
    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) 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 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
    Prevention of immune mediated allograft rejection in patients with end-stage renal disease (ESRD) who are tissue typed as HLA-A*02 negative
    and have received a kidney transplant from an HLA-A*02 positive living donor.
    E.1.1.1Medical condition in easily understood language
    Prevention of kidney graft rejection in patients who have received a kidney transplant due to chronic renal insufficiency.
    E.1.1.2Therapeutic area Body processes [G] - Immune system processes [G12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10050436
    E.1.2Term Prophylaxis against renal transplant rejection
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    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 long-term safety and tolerability of TX200-TR101 up to 15 years post-TX200-TR101 infusion/baseline.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of TX200-TR101 on long-term graft-related outcomes up to 15 years post-TX200-TR101 infusion/baseline.

    To evaluate the effect of TX200-TR101 on long-term safety outcomes up to 15 years post-TX200-TR101 infusion/baseline.

    To evaluate the composite efficacy profile of TX200-TR101 up to 15 years post-TX200-TR101 infusion/baseline.

    To evaluate quality of life over time up to 15 years post-TX200-TR101 infusion/baseline.

    To evaluate the long-term persistence of CAR-Tregs and impact in the periphery up to 15 years post-TX200-TR101 infusion/baseline (if available).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subjects who enrolled in the Phase I/IIa study TX200-KT02, received a transplanted kidney and have either completed or withdrawn from that study.
    2. Willing and able to provide written informed consent (IC) in accordance with local regulations and governing Independent Ethics Committee (IEC)/Institutional Review Board (IRB) requirements prior to any procedure or evaluation performed specifically for the sole purpose of the study.
    E.4Principal exclusion criteria
    1. Subjects/persons committed to an institution following an administrative or judicial order.
    E.5 End points
    E.5.1Primary end point(s)
    From the day of TX200-TR101 infusion through to 15 years post-TX200-TR101 infusion/baseline:

    • Overall survival
    • Incidence and grade of Serious Adverse Events (SAEs).
    E.5.1.1Timepoint(s) of evaluation of this end point
    From the day of TX200-TR101 infusion through to 15 years post-TX200-TR101 infusion/baseline
    E.5.2Secondary end point(s)
    • Incidence of immune-mediated rejection in terms of BCAR episodes according to the Banff criteria (including type, severity and timing)
    • Incidence of graft loss due to rejection
    • Incidence and severity of chronic graft dysfunction, as measured by eGFR
    • Incidence and (semi-quantitative) intensity of de novo donor-specific anti-HLA antibodies (DSA).

    • Number of in-patient days in hospital
    • Incidence of any Adverse Events (AEs)considered related to TX200-TR101 according to the investigator
    • Incidence of Adverse Events of Special Interest (AESI), including:
    o Infections requiring medical intervention, where severity is Grade 2 or greater. Any infection that is suspected or confirmed
    opportunistic in nature; new-onset diabetes mellitus (NODM), new or aggravation of hypertension, new malignancies, or new (up-to 8 years post-infusion) dyslipidaemia requiring medical intervention
    • Change in immunosuppression regimen to include:
    o Target levels in blood for each immunosuppressant.
    o Number and name of drugs given to achieve intended level of immunosuppression.
    o Any incidence of rescue medication given to avoid potential imminent rejection episode.
    • Incidence of anti-drug antibodies against HLA-A2 CAR-Tregs.

    o Death, or;
    o Incidence of immune-mediated rejection in terms of BCAR episodes according to the Banff criteria (including type, severity and timing), or;
    o Incidence of graft loss due to rejection, or;
    o Incidence and severity of chronic graft dysfunction, as measured by eGFR

    Absolute value and change from baseline in SF-36v2®

    Levels (absolute values) and changes from baseline (i.e. Pre- TX200-TR101 infusion/baseline) in biomarkers in blood relating to the presence of HLA-A2 CAR-Tregs
    E.5.2.1Timepoint(s) of evaluation of this end point
    From the day of TX200-TR101 infusion through to 15 years post-TX200-TR101 infusion/baseline
    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 No
    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 No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 Yes
    E.8.1.7.1Other trial design description
    Long-Term Follow-Up study
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA5
    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
    United Kingdom
    Belgium
    Germany
    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 years17
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days1
    E.8.9.2In all countries concerned by the trial years17
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days1
    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: 10
    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 state5
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 15
    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 Decision2023-02-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-03-31
    P. End of Trial
    P.End of Trial StatusOngoing
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