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    Summary
    EudraCT Number:2016-004808-60
    Sponsor's Protocol Code Number:HD-CAR-1/V03
    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:2017-07-25
    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 number2016-004808-60
    A.3Full title of the trial
    Treatment of patients with relapsed or refractory CD19+ lymphoid disease with T lymphocytes transduced by RV-SFG.CD19.CD28.4-1BBzeta retroviral vector - A unicenter Phase I /II clinical trial
    Behandlung von Patienten mit RV-SFG.CD19.CD28.4 retroviralem Vektor transduzierten T-Lymphozyten bei rezidivierenden oder refraktären CD19+ Leukämien und Lymphomen. Eine monozentrische Studie (Phase I/II)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment of patients with CD19+ hematologic disease with T lymphocytes transduced retrovirally with a third generation CAR
    Behandlung von Patienten mit CD19+ Leukämien und Lymphomen mit retroviral transduzierten T-Lymphozyten (CAR T-Zellen der dritten Generation).
    A.3.2Name or abbreviated title of the trial where available
    3G-CART therapy for CD19+ lymphoid disease
    A.4.1Sponsor's protocol code numberHD-CAR-1/V03
    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 SponsorUniversity Hospital Heidelberg
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportUniversity Hospital Heidelberg
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Heidelberg
    B.5.2Functional name of contact pointProf. Dr. Michael Schmitt
    B.5.3 Address:
    B.5.3.1Street AddressIm Neuenheimer Feld 410
    B.5.3.2Town/ cityHeidelberg
    B.5.3.3Post code69120
    B.5.3.4CountryGermany
    B.5.4Telephone number+49622156-6614
    B.5.5Fax number+49622156-5740
    B.5.6E-mailMichael.Schmitt@med.uni-heidelberg.de
    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 nameCD19.CAR T cells
    D.3.4Pharmaceutical form 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 INN3G. CD19 CAR T Cells
    D.3.9.2Current sponsor codeHD-CAR-1
    D.3.9.3Other descriptive name3G. CD19 CAR T Cells
    D.3.9.4EV Substance CodeSUB182373
    D.3.10 Strength
    D.3.10.1Concentration unit m2 square meter
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number1000000 to 20000000
    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 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
    Relapsed and/or refractory CD19+ leukemia and lymphoma
    Rezidivierte und/oder refraktäre CD19+ Leukämien und Lymphome
    E.1.1.1Medical condition in easily understood language
    Malignant hematopoietic diseases resistant to Treatment or relapsed after Treatment.
    Bösartige Erkrankungen des blutbildenden Systems, welche schwer oder nicht auf herkömmliche Therapien ansprechen.
    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 20.0
    E.1.2Level LLT
    E.1.2Classification code 10063625
    E.1.2Term Acute lymphoblastic leukemia recurrent
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10029595
    E.1.2Term Non-Hodgkin's lymphoma NOS refractory
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary
    Safety:
    - Assessment of toxicities according to the Common Terminology Criteria for Adverse Events (CTCAE v4.03)
    - Assessment of frequency and grade of cytokine release syndrome (CRS) and/or neurotoxicity
    - Assessment of dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD)

    Feasibility:
    - Yield of sufficient nucleated cells (NC) by leukapheresis
    - Successful transduction (≥ 15%) of CD3+ T cells (TCs)
    - Yield of the respective dose of transduced TCs
    E.2.2Secondary objectives of the trial
    Secondary
    - Evaluation of survival and function of chimeric antigen receptor (CAR) TCs directed against CD19 (CD19.CAR TC) in vivo
    - Characterization of in vivo cellular pharmakokinetics
    - Correlation of clinical response and number of circulating gene modified cells
    - Reduction of disease burden with CD19.CAR TC transfusions
    - Anti-tumor efficacy of CD19.CAR TCs in patients with CD19+ lymphoid disease (overall response rate (ORR), complete response (CR), partial response (PR)) at day 90 (EOS) after CD19.CAR TC transfusion)
    - Time to response (at least PR) after the CD19.CAR TC transfusion
    - Duration of overall response (DOR) after the CD19.CAR TC transfusion
    - Progression-free survival (PFS) after the CD19.CAR TC transfusion
    - Overall survival (OS) after the CD19.CAR TC transfusion
    - Correlation of B-cell depletion in vivo and response to CD19.CAR TC treatment
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Stratum 1-2 (Adults):
    Inclusion Criteria:
    - Confirmed CD19+ ALL, CLL, DLBCL, FL or MCL in patients ≥ 18 years
    - ALL: Confirmed CD19+ ALL (Philadelphia (Ph) + and Ph-) by cytology and flow cytometry (FACS) AND
    - Relapsed or refractory disease (incl. “molecular relapse” with min. residual disease (MRD) levels > 10-3 at two occasions > 2 weeks apart) with confirmed CD19-expression on malign. cells
    - Any relapse after allogeneic stem cell transplantation (alloSCT) (≥ 6 months from alloSCT at time of CAR TC infusion) OR
    - Any relapse failing to achieve an MRD level of < 10-3 after ≥ 2 lines of treatment OR
    - Primary refractory as defined by not achieving a CR after ≥ 2 lines of treatment
    - CLL/NHL: Confirmed CD19+ CLL/NHL (incl. CLL, DLBCL, FL or MCL):
    - CLL in need of treatment with:
    (1) Early relapse (within 2 years) after end of chemoimmunotherapy or chemoimmunotherapy refractoriness plus failure or intolerance of both BTK and BCL2 inhibitors OR
    (2) Relapse after alloSCT, ineligible for or refractory to standard interventions (donor lymphocyte infusions (DLI), CD20 antibodies, chemoimmunotherapy)
    - DLBCL with:
    (1) Refractoriness to a 2nd or later line of chemoimmunotherapy OR
    (2) Relapse after autoSCT plus ineligibility for alloSCT (incl. refractoriness to one line of salvage chemoimmunotherapy) OR
    (3) Relapse after alloSCT
    - FL in need of treatment with:
    (1) Relapse <2 years after chemoimmunotherapy AND ineligibility for or failure of autoSCT AND ineligibility for or failure of idelalisib OR
    (2) Relapse after alloSCT, ineligible for or refractory to standard interventions (donor lymphocyte infusions, CD20 antibodies, chemoimmunotherapy)
    - MCL with:
    (1) Relapse after standard first-line therapy AND ineligibility for or failure to BTKi salvage therapy OR
    (2) Relapse after alloSCT AND ineligibility for or failure to BTKi salvage therapy
    - Measurable disease/MRD at time of enrollment
    - Life expectancy ≥ 12 weeks
    - ECOG performance status ≤ 2 at the time of screening
    - Adequate organ function:
    - Renal function defined as: serum creatinine of ≤ 2 x ULN or eGFR ≥ 30 mL/min/1.73 m2
    - Liver function defined as:
    - ALT ≤ 5 times the ULN for the respective age
    - Bilirubin ≤ 2.0 mg/dl with the exception of patients with hyperbilirubinemia explained by Gilbert–Meulengracht syndrome (may be included if total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) or extrahepatic disease (e.g. chronic hemolytic anemia)
    - min. level of pulmonary reserve defined as ≤ grade 1 dyspnea and pulse oxygenation > 90% on room air
    - Hemodynamic stability and LVEF ≥ 40% as confirmed by echocardiogram
    - Abs. neutrophil count (ANC) ≥ 500/mm3
    - Abs. lymphocyte count (ALC) ≥ 100/mm3
    - Women of child-bearing potential (defined as all women physiolog. capable of becoming pregnant) and all male participants must agree to use highly effective methods of contraception for one year following CD19.CAR TC therapy
    - Written informed consent must be obtained prior to any screening procedures

    Stratum 3 (Children and Adolescents with ALL):
    Inclusion Criteria:
    - Age of > 3 years until < 18 years at the time of screening
    - CD19+ ALL (Ph+ and Ph-) confirmed by cytology and flow cytometry (FACS) AND
    - Relapsed or refractory disease (incl. “molecular relapse” with PCR-MRD > 10-3 at two occasions > 2 weeks apart) with confirmed CD19-expression on malign. cells
    - Any relapse after alloSCT (≥ 6 months from alloSCT at time of CAR TC infusion) OR
    - Any relapse failing to achieve an MRD level of < 10-3 after ≥ 2 lines of treatment OR
    - Primary refractory as defined by not achieving a CR after ≥ 2 lines of treatment
    - Measurable disease/MRD at time of enrollment
    - Life expectancy ≥ 12 weeks
    - ECOG performance status ≤ 2 (age ≥ 16 years) or Lansky performance status ≥ 50 (age < 16 years) at time of screening
    - Adequate organ function:
    - Renal function defined as serum creatinine-clearance ≥ 30 mL/min/1.73 m2
    - Liver function defined as:
    - ALT ≤ 5 times the ULN for the respective age
    - Bilirubin ≤ 2.0 mg/dl with the exception of patients with hyperbilirubinemia explained by Gilbert–Meulengracht syndrome or extrahepatic disease (e.g. chronic hemolytic anemia)
    - min. level of pulmonary reserve defined as ≤ grade 1 dyspnea and pulse oxygenation > 90% on room air
    - Hemodynamic stability and LVEF ≥ 40% or shortening fraction > 29% as confirmed by echocardiogram
    - Abs. neutrophil count (ANC) ≥ 500/mm3
    - Abs. lymphocyte count (ALC) ≥ 100/mm3
    - Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) and postpubertal male participants must agree to use highly effective methods of contraception for one year following CD19.CAR TC therapy
    - Ability to understand the nature of the trial and the trial related procedures
    - Written informed consent of the study patient and the legal representative must be obtained prior to any screening procedures
    E.4Principal exclusion criteria
    Exclusion Criteria
    Stratum 1-2 (Adults):
    - The following medications are excluded:
    - Immunosuppressive medication with the exception of ≤ 30 mg prednisolone/d or equivalent at the time of CAR TC transfusion
    - Bridging/maintenance therapy including chemo- and immunotherapy must be stopped ≥ 2 weeks prior to leukapheresis, but can be continued between leukapheresis and lymphodepletion
    - Intrathecal chemotherapy is possible at any time, but not during lymphodepletion until 14 days after CD19.CAR TC transfusion
    - Any donor lymphocyte infusions (DLI) must be completed > 6 weeks prior to CD19.CAR TC infusion
    - Florid/acute or chronic Graft-versus-Host disease (GvHD)
    - Uncontrolled active hepatitis B or C
    - HIV-positivity
    - Uncontrolled acute life-threatening bacterial, viral or fungal infection
    - Severe concomitant disease (e.g. uncontrolled arterial hypertension, heart failure NYHA III-IV, uncontrolled diabetes mellitus, uncontrolled hyperlipidemia)
    - Unstable angina and/or myocardial infarction within 3 months prior to screening
    - Any previous or concurrent malignancy.
    - The following exceptions do not constitute exclusion criteria:
    - Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to study entry)
    - In situ carcinoma of the cervix or breast, treated curatively without evidence of recurrence ≥ 3 years prior to the study
    - CLL or FL transformed into an aggressive B cell lymphoma
    - A primary malignancy which is in complete remission for ≥ 5 years
    - Pregnant or nursing (lactating) women
    - Intolerance to the excipients of the cell product
    - Active CNS involvement in ALL patient at the time of screening is not an exclusion criterion, but patients with CNS 3 status at clinical screening (d-14) are not eligible for CD19.CAR TC transfusion
    - Participation in another clinical trial at the time of screening

    Exclusion Criteria
    Stratum 3 (Children and Adolescents with ALL):
    - The following medications are excluded:
    - immunosuppressive medication with the exception of < 0.5 mg/d*kg BW prednisolone-equivalent at the time of CD19.CAR TC transfusion
    - Bridging/Maintenance therapy including chemo- and immunotherapy must be stopped ≥ 2 weeks prior to leukapheresis, but can be continued between leukapheresis and lymphodepletion.
    - Intrathecal chemotherapy is possible at any time, but not during lymphodepletion until 14 days after CD19.CAR TC transfusion
    - Any donor lymphocyte infusions (DLI) must be completed > 6 weeks prior to CD19.CAR TC infusion
    - Florid/acute or chronic Graft-versus-Host disease (GvHD)
    - Uncontrolled active hepatitis B or C
    - HIV-positivity
    - Uncontrolled acute life-threatening bacterial, viral or fungal infection
    - Severe concomitant disease (e.g. any life-limiting genetic disorder). Patients with Down Syndrome will not be excluded.
    - Any previous or concurrent malignancy.
    - The following exceptions do not constitute exclusion criteria:
    - Lymphoblastic lymphoma transformed into a CD19+ acute lymphoblastic leukemia
    - A primary malignancy which is in complete remission for ≥ 5 years
    - Pregnant or nursing (lactating) women
    - Intolerance to the excipients of the cell product
    - Active CNS involvement at the time of screening is not an exclusion criterion, but patients with CNS 3 status at clinical screening (d-14) are not eligible for CD19.CAR TC transfusion
    - Participation in another clinical trial at the time of screening
    E.5 End points
    E.5.1Primary end point(s)
    Primary
    Safety:
    - Assessment of toxicities according to the Common Terminology Criteria for Adverse Events (CTCAE v4.03)
    - Assessment of frequency and grade of cytokine release syndrome (CRS) and/or neurotoxicity
    - Assessment of dose-limiting toxicity (DLT) and maximum-tolerated dose (MTD)

    Feasibility:
    - Yield of sufficient nucleated cells (NC) by leukapheresis
    - Successful transduction (≥ 15%) of CD3+ T cells (TCs)
    - Yield of the respective dose of transduced TCs


    E.5.1.1Timepoint(s) of evaluation of this end point
    - End of Trial: d+28
    +/- 3d (after CAR T-Cell Administration)

    - End of Study: d+90
    +/- 3d (after CAR T-Cell Administration)

    E.5.2Secondary end point(s)
    Secondary
    - Evaluation of survival and function of chimeric antigen receptor (CAR) TCs directed against CD19 (CD19.CAR TC) in vivo
    - Characterization of in vivo cellular pharmakokinetics
    - Correlation of clinical response and number of circulating gene modified cells
    - Reduction of disease burden with CD19.CAR TC transfusions
    - Anti-tumor efficacy of CD19.CAR TCs in patients with CD19+ lymphoid disease (overall response rate (ORR), complete response (CR), partial response (PR)) at day 90 (EOS) after CD19.CAR TC transfusion)
    - Time to response (at least PR) after the CD19.CAR TC transfusion
    - Duration of overall response (DOR) after the CD19.CAR TC transfusion
    - Progression-free survival (PFS) after the CD19.CAR TC transfusion
    - Overall survival (OS) after the CD19.CAR TC transfusion
    - Correlation of B-cell depletion in vivo and response to CD19.CAR TC treatment

    E.5.2.1Timepoint(s) of evaluation of this end point
    - End of Trial: d+28
    +/- 3d (after CAR T-Cell Administration)

    - End of Study: d+90
    +/- 3d (after CAR T-Cell Administration)
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    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 No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase I/II: safety and feasibiltiy
    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 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
    End of trial (EOT) is set on day 28+/-3 days after CAR TC application. 2 further visits will follow until end of study (EOS) is achieved on day +90+/-days. EOS is LVLS.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    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: 16
    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: 8
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 8
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 32
    F.1.3Elderly (>=65 years) No
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    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 state48
    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)
    Planned treatment after study end
    The investigator will continue to observe all patients (also withdrawals) for intolerable AEs/ SAEs until the findings have been clarified or became stable.
    Patients enrolled in this study will be seen on a regular basis at least once a year at the study institution and evaluated for a total of 15 years for adults and pediatric patients, respectively. Monitoring will Focus particularly on any occurrence of secondary malignancies or autoimmune diseases.
    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 Decision2018-04-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-27
    P. End of Trial
    P.End of Trial StatusOngoing
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