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    Summary
    EudraCT Number:2019-001730-34
    Sponsor's Protocol Code Number:TX200-KT02
    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:2019-09-17
    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 number2019-001730-34
    A.3Full title of the trial
    A Multicentre, Open-Label, Single Ascending Dose, Dose-Ranging, Phase I/IIa Study to Evaluate the Safety and Tolerability of an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (TX200-TR101) in Living Donor Renal Transplant Recipients
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase I/IIa Study to Evaluate the Safety and Tolerability of an Autologous Antigen-Specific Chimeric Antigen Receptor T Regulatory Cell Therapy (TX200-TR101) in Living Donor Renal Transplant Recipients
    A.4.1Sponsor's protocol code numberTX200-KT02
    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-KT02 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-mailclinicaltrials@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 No
    D.2.5.1Orphan drug designation number
    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-DS
    D.3.9.3Other descriptive nameAutologous HLA-A2 CAR T regulatory cells
    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 Yes
    D.3.11.3.5.1CAT classification and reference numberGene therapy medicinal product, EMA/399634/2020
    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 100000004865
    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 short-term safety and tolerability of TX200-TR101 from the day of TX200-TR101 infusion within 28 days post TX200-TR101 infusion.
    E.2.2Secondary objectives of the trial
    • To evaluate the effect of TX200-TR101 on acute graft-related outcomes from the day of TX200-TR101 infusion through to Week 84 in terms of biopsy-confirmed acute rejection (BCAR).
    • To evaluate the effect of TX200-TR101 on long-term safety outcomes from the day of TX200-TR101 infusion through to Week 84 in terms of treatment emergent adverse events(TEAEs).
    • To evaluate the reduction of immunosuppression over time through to Week 84.
    • To evaluate TX200-TR101 localisation in the graft at Week 16.
    • To evaluate the effect of TX200-TR101 on chronic graft-related outcomes from the day of TX200-TR101 infusion through to Week 84.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The following inclusion criteria must be met for all transplant recipients (i.e., recipients to be administered TX200-TR101 and control recipients):
    Inclusion Criteria (All Transplant Recipients)
    1. 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.
    2. Male or female aged between 18 and 70 (inclusive) years.
    3. Have diagnosis of ESRD and currently waiting for a new kidney from an identified live donor.
    4. Subjects who will be single organ recipients (kidney).
    5. Women who are of childbearing potential must have a negative serum pregnancy test at screening and before transplantation.
    6. Able and willing to use a highly effective method of contraception from the signing of the informed consent through the last study visit, for male and female subjects with reproductive potential.

    Additional Inclusion Criteria (Transplant Recipients to be Administered TX200-TR101 Only)
    The following additional criteria must be met for transplant recipients to be administered TX200- TR101:
    1. HLA-A*02 negative typing (the kidney graft needs to be HLA A*02 positive).
    2. HLA-A*69 negative typing.
    3. Adequate venous access for leukapheresis, and no other contraindications for leukapheresis.

    Additional Inclusion Criteria (Transplant Donors for Transplant Recipients to be Administered TX200- TR101 Only)
    The following additional inclusion criterion must be met for transplant donors for transplant recipients to be administered TX200-TR101:
    1. HLA-A*02 positive typing.

    E.4Principal exclusion criteria
    Exclusion Criteria (All Transplant Recipients)
    1.HLA identical to the prospective organ donor.
    2.Subjects with prior organ transplant.
    3.Positive flow cytometric crossmatch using donor lymphocytes and recipient serum.
    4.Subjects with panel-reactive antibody (PRA) >20% within 6 months prior to enrolment.
    5. Subjects with current or recent (within 6 months) donor-specific antibodies.
    6. Subjects with underlying renal disease with a high risk of disease reoccurrence in the transplanted kidney including primary focal segmental glomerulosclerosis, types I or II membranoproliferative glomerulonephritis, C3 glomerulopathy, or haemolytic-uraemic syndrome (HUS), including atypical HUS.
    7. Concomitant clinically active local or systemic infection.
    8. Clinical evidence of significant unstable or uncontrolled acute or chronic diseases (i.e., cardiovascular, pulmonary, haematologic, gastrointestinal, hepatic, neurological, malignancy or infectious diseases) or laboratory abnormality (except ESRD) which, in the opinion of the investigator, could confound the results of the study or put the subject at undue risk.
    E.5 End points
    E.5.1Primary end point(s)
    Incidence and grade of TEAEs, including serious adverse events (SAEs) throughout 28 days post TX200-TR101 infusion.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The timepoint of evaluation of the primary endpoint is given in the section above ( E.5.1)
    E.5.2Secondary end point(s)
    From the day of TX200-TR101 infusion through to Week 84 unless otherwise specified below:
    •Incidence of BCAR according to the Banff criteria.
    •Time to first BCAR episode.
    •Type and severity of any BCAR episodes according to the Banff criteria.
    •Incidence and grade of TEAEs, including SAEs.
    •Incidence of opportunistic infections, specifically BK virus (BKV), Epstein-Barr virus (EBV) and cytomegalovirus (CMV) reactivation
    •Incidence of neoplasia.
    •Proportion of subjects who are receiving tacrolimus monotherapy at Week 84.
    •Cumulative dose of immunosuppression, including but not limited to mycophenolic acid (MPA)/mycophenolate mofetil (MMF) and tacrolimus through to Week 84.
    •Presence of CD4 RNA transcript positive cells that are also positive for HLA-A2 CAR RNA transcripts in the renal transplant biopsy at Week 16.
    •Incidence and severity of chronic graft dysfunction, as measured by estimated glomerular filtration rate (eGFR).
    •Incidence and severity of chronic graft dysfunction, as measured by the Banff criteria for chronic rejection including the Banff lesion score inflammation in area of interstitial fibrosis and tubular atrophy (i-IFTA).
    •Incidence of graft loss due to rejection.
    •Incidence and (semi-quantitative) intensity of de novo DSA.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The timepoint of evaluation of each secondary endpoint is given in the section above (E.5.2).
    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) 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 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
    LVLS (Last visit of the last subject)
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 30
    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)
    Upon completion of this study, Transplant recipients, including control subjects, will be asked if they will participate in an additional, optional long-term follow-up study (within a separate protocol) after Week 84.
    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 Decision2019-11-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-03-24
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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