<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03789617</url>
  </required_header>
  <id_info>
    <org_study_id>EBViNT</org_study_id>
    <nct_id>NCT03789617</nct_id>
  </id_info>
  <brief_title>A Multi-center, Single-arm, Open, Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of EBViNT Cell (EBV Specific Autologous CD8+ T Cell) in Patients With Treatment Failed Epstein Barr Virus (EBV)-Positive Malignancies</brief_title>
  <official_title>A Multi-center, Single-arm, Open, Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of EBViNT Cell (EBV Specific Autologous CD8+ T Cell) in Patients With Treatment Failed Epstein Barr Virus (EBV)-Positive Malignancies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eutilex</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eutilex</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study is a multi-center, single-arm, open, phase I/IIa clinical trial to evaluate&#xD;
      the efficacy and safety of EBViNT Cell when administered to patients with Epstein-Barr (EBV)&#xD;
      positive malignancies The present study investigates with 5 parts; Part1-phase I: IP single&#xD;
      therapy on ENKL and solid tumors Part2-phase I: IP + lymphodepletion on solid tumors Part&#xD;
      3&amp;5- Phase IIa: IP single therapy on each ENKL and solid tumors Part 4- Phase IIa: IP +&#xD;
      lymphodepletion on solid tumors&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study is a multi-center, single-arm, open, phase I/IIa clinical trial to evaluate&#xD;
      the efficacy and safety of EBViNT Cell when administered to patients with Epstein-Barr (EBV)&#xD;
      positive tumors&#xD;
&#xD;
      After proving the safety through Part 1 and part 2, the efficacy and safety would be studied&#xD;
      through part 3~5.&#xD;
&#xD;
        -  If CTCAE grade 3 or higher adverse drug events (ADR) do not occur in the three subjects:&#xD;
           Begin enrollment for phase IIa&#xD;
&#xD;
        -  If a CTCAE grade 3 or higher ADR occurs in one of the three subjects: Enroll three more&#xD;
           subjects (up to six subjects in total) and assess whether any CTCAE grade 3 or higher&#xD;
           ADR occurs&#xD;
&#xD;
             -  If a CTCAE grade 3 or higher ADR does not occur in the three additional subjects&#xD;
                (1/6): Begin enrollment for phase IIa&#xD;
&#xD;
             -  If a CTCAE grade 3 or higher ADR occurs in at least one of the three additional&#xD;
                subjects (more than 2/6): Begin enrollment for phase IIa at 7.0x10^8 cells, the&#xD;
                maximum dose from phase I&#xD;
&#xD;
        -  If a CTCAE grade 3 or higher ADR occurs in two of the three subjects: Begin enrollment&#xD;
           for phase IIa at 7.0x10^8 cells, the maximum dose from phase I&#xD;
&#xD;
      Subjects participating in the present study will undergo 1) an EBV epitope screening test&#xD;
      followed by 2) an eligibility assessment for clinical trial enrollment.&#xD;
&#xD;
      Subjects who are administered with the investigational product will be monitored until&#xD;
      progressive disease (PD) is confirmed or for 24 weeks (main observation period of 4 weeks +&#xD;
      monitoring for 20 weeks) to evaluate the product's safety and efficacy, and will undergo&#xD;
      immunological assessment.&#xD;
&#xD;
      Radiological tests for tumor assessment will be conducted at the enrollment visit, 4 weeks, 8&#xD;
      weeks, 16 weeks, and 24 weeks and assessed by the Independent Radiology Review Committee&#xD;
      (IRRC) using the Lugano criteria. To eliminate pseudo-progression, progressive disease (PD)&#xD;
      will be determined by considering immunological tests, a quantitative EBV DNA assay, and&#xD;
      intermediate response (IR) under LYRIC. Biopsies may be performed to achieve this.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 14, 2018</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2022</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Confirmed objective response rate (confirmed ORR) [assessed by IRRC]</measure>
    <time_frame>up to 6 month from LPI</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DoR) [assessed by IRRC and investigator]</measure>
    <time_frame>up to 6 month from LPI</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR) [assessed by IRRC and investigator]</measure>
    <time_frame>up to 6 month from LPI</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective response rate (ORR) [assessed by investigator]</measure>
    <time_frame>up to 6 month from LPI</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete response rate (CR rate) [assessed by IRRC and investigator]</measure>
    <time_frame>up to 6 month from LPI</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Partial response rate (PR rate) [assessed by IRRC and investigator]</measure>
    <time_frame>up to 6 month from LPI</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Partial response duration (PR duration) [assessed by IRRC and investigator]</measure>
    <time_frame>up to 6 month from LPI</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>up to 6 month from LPI</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>up to 6 month from LPI</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Immunological assessment</measure>
    <time_frame>up to 6 month</time_frame>
    <description>Plasma cytokine analysis (IL-1b, IL-2, IL-4, IL-6, IL-8, IL-10, TNF, IFN-γ, IL-17a) EBV LMP2a-specific cytokine production (IL-1b, IL-2, IL-4, IL-6, IL-8, IL-10, TNF, IFN-γ, IL-17a) Phenotypical analysis of CD8 T cells</description>
  </other_outcome>
  <other_outcome>
    <measure>Quantitative EBV DNA assay</measure>
    <time_frame>up to 6 month</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">72</enrollment>
  <condition>EBV Associated Extranodal NK/T-cell Lymphoma</condition>
  <condition>EBV-Associated GastricCarcinoma or Esophageal AdenoCarcinoma</condition>
  <arm_group>
    <arm_group_label>EBViNT Cell</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>EBViNT Cell</intervention_name>
    <description>Dosage: 1 bag containing 1.4x10^9 cells/100mL&#xD;
Administration: Inject intravenously over 30 minutes&#xD;
Dosing schedule: Single dose</description>
    <arm_group_label>EBViNT Cell</arm_group_label>
    <other_name>Eutil autologous blood-derived T lymphocytes</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria (Visit 1)&#xD;
&#xD;
          1. At least 19 years of age&#xD;
&#xD;
          2. Patients with lymphomas or solid tumors who have been found to be positive for EBV&#xD;
             encoded RNA (EBER) by in situ hybridization (ISH) (previous test results may be used&#xD;
             as evidence if available)&#xD;
&#xD;
               1. Part 1: Histologically or cytologically confirmed lymphoma or solid tumor&#xD;
&#xD;
               2. Part 2: Histologically or cytologically confirmed solid tumor&#xD;
&#xD;
               3. Part 3: Patients who have been diagnosed with histologically confirmed extranodal&#xD;
                  NK/T-cell lymphoma (ENKL) according to WHO classification&#xD;
&#xD;
               4. Parts 4 and 5: Patients with histologically confirmed gastric cancer or&#xD;
                  esophageal adenocarcinoma&#xD;
&#xD;
          3. Patients who have given written consent to voluntarily participate in the epitope&#xD;
             screening&#xD;
&#xD;
        Exclusion Criteria (Visit 1)&#xD;
&#xD;
          1. Patients with aggressive NK cell leukemia&#xD;
&#xD;
          2. Patients with hemophagocytic lymphohistiocytosis (HLH)&#xD;
&#xD;
          3. Persons who have previously received a solid organ transplant&#xD;
&#xD;
          4. Persons who have been diagnosed with a malignant tumor other than the target disease&#xD;
             in the past 5 years (treated basal cell carcinoma, squamous epithelial cell carcinoma,&#xD;
             and non-invasive cervical cancer do not necessitate exclusion)&#xD;
&#xD;
          5. Patients in whom a tuberculosis infection was confirmed in the 1 year prior to&#xD;
             screening for the present study (However, patients who have been determined to be&#xD;
             cured after treatment may be enrolled.)&#xD;
&#xD;
          6. Patients who test positive for anti-HIV antibodies&#xD;
&#xD;
          7. Patients deemed unsuitable to participate in the clinical trial by an investigator&#xD;
             based on active infection (HBV, HCV) test results&#xD;
&#xD;
        Enrollment Criteria (Visit 2)&#xD;
&#xD;
          1. Persons who have been found to be capable of production in the epitope screening test&#xD;
&#xD;
          2. Patients who have failed standard treatment or conventional chemotherapy and who meet&#xD;
             any one of the following&#xD;
&#xD;
               1. Patients who have relapsed/progressed after 1 or more chemotherapies, and for&#xD;
                  whom standard treatment does not exist or cannot be performed&#xD;
&#xD;
               2. Intolerable patients for whom anticancer treatment cannot be performed or a&#xD;
                  minimum of one full cycle cannot be completed in a first-line chemotherapy&#xD;
&#xD;
               3. Patients who are refractory to first-line chemotherapy&#xD;
&#xD;
          3. Persons with evaluable lesions&#xD;
&#xD;
               1. Lymphoma: Persons with at least 1 lesion with long axis &gt; 15 mm or 18FDG-PET-CT&#xD;
                  avid&#xD;
&#xD;
               2. Solid tumor: Persons with at least 1 measurable lesion based on RECIST 1.1&#xD;
&#xD;
          4. Persons with appropriate liver, renal, and bone marrow function (two retests are&#xD;
             permitted for borderline results, and corrections such as transfusion are permitted)&#xD;
&#xD;
        Exclusion criteria (Visit 2)&#xD;
&#xD;
          1. Where central nervous system (CNS) lymphoma or uncontrolled CNS metastasis is present&#xD;
             (patients with brain metastasis that has been treated and is stable [stable for at&#xD;
             least 30 days based on radiology records] may be enrolled)&#xD;
&#xD;
          2. Persons who have received surgery, radiotherapy, or chemotherapy in the 3 weeks prior&#xD;
             to the investigational product administration&#xD;
&#xD;
          3. Persons who have been administered any other investigational product in the 3 weeks&#xD;
             prior to the investigational product administration&#xD;
&#xD;
          4. Persons who have not recovered from the toxicity of any previous treatment to Grade 1&#xD;
             or lower based on NCI CTCAE v5.0 (however, clinically insignificant toxicities such as&#xD;
             alopecia are excluded)&#xD;
&#xD;
          5. Patients who have received immunosuppressants, including steroids, in the 10 days&#xD;
             prior to blood collection (Visit 2) for production of the study drug (however, local&#xD;
             steroids and steroids for inhalers are permitted, and steroid equivalent to 20 mg/day&#xD;
             of prednisolone may be administered at the investigator's discretion)&#xD;
&#xD;
          6. Patients with the following (but not limited to) clinically significant cardiovascular&#xD;
             comorbidities as determined by the investigator&#xD;
&#xD;
             : Uncontrolled hypertension (i.e., systolic pressure &gt; 180 mmHg and/or diastolic&#xD;
             pressure &gt; 100 mm/Hg), unstable angina, pulmonary embolism, cerebrovascular disease,&#xD;
             valvular disease, congestive heart failure (NYHA severity classification Grade III or&#xD;
             IV), or myocardial infarction or serious cardiac arrhythmia within the 24 weeks prior&#xD;
             to the enrollment visit&#xD;
&#xD;
          7. Patients with findings of autoimmune or inflammatory disease, whose abnormal results&#xD;
             from an autoimmune response test have been deemed clinically significant by an&#xD;
             investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hyeon Seok Eom, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Cancer Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Won Seog Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ho Jin Shin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pusan National University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Min-hee Ryu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Cente</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Won Sik Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Inje University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Minsuk Kwon, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ajou Univ. Hosp.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hyo song Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Severance Hosp</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jeeyun Lee, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Samsung Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sehee Hwang</last_name>
    <phone>+82-2-2071-3310</phone>
    <email>hsh0820@eutilex.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Gangnam-gu</state>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Won Seog Kim, Dr</last_name>
      <phone>82221487390</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Goyang-si</city>
        <state>Gyeonggi-do</state>
        <zip>10408</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hyeon Seok Eom, Dr</last_name>
      <phone>82319201165</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Inje Univ. Hosp</name>
      <address>
        <city>Pusan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Won Sik Lee, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pusan national Univ. Hosp.</name>
      <address>
        <city>Pusan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ho Jin Shin, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jeeyun Lee, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Seoul Asan Medical center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Min-hee Ryu, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Severance hosp.</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Hyo Song Kim, MD, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Ajou Univ Hosp.</name>
      <address>
        <city>Suwon</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Minsuk Kwon, MD, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <link>
    <url>http://www.eutilex.com/en/</url>
    <description>Web address</description>
  </link>
  <reference>
    <citation>Eom HS, Choi BK, Lee Y, Lee H, Yun T, Kim YH, Lee JJ, Kwon BS. Phase I Clinical Trial of 4-1BB-based Adoptive T-Cell Therapy for Epstein-Barr Virus (EBV)-positive Tumors. J Immunother. 2016 Apr;39(3):140-8. doi: 10.1097/CJI.0000000000000113.</citation>
    <PMID>26938947</PMID>
  </reference>
  <reference>
    <citation>Choi BK, Lee SC, Lee MJ, Kim YH, Kim YW, Ryu KW, Lee JH, Shin SM, Lee SH, Suzuki S, Oh HS, Kim CH, Lee DG, Hwang SH, Yu EM, Lee IO, Kwon BS. 4-1BB-based isolation and expansion of CD8+ T cells specific for self-tumor and non-self-tumor antigens for adoptive T-cell therapy. J Immunother. 2014 May;37(4):225-36. doi: 10.1097/CJI.0000000000000027.</citation>
    <PMID>24714356</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>December 27, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>July 7, 2022</last_update_submitted>
  <last_update_submitted_qc>July 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Cytotoxic T cell</keyword>
  <keyword>Lymphoma</keyword>
  <keyword>Immuno-oncology</keyword>
  <keyword>ENKL</keyword>
  <keyword>EBViNT</keyword>
  <keyword>Gastric cancer</keyword>
  <keyword>solid tumor</keyword>
  <keyword>Esophageal AdenoCarcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epstein-Barr Virus Infections</mesh_term>
    <mesh_term>Adenocarcinoma</mesh_term>
    <mesh_term>Lymphoma, Extranodal NK-T-Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03789617
org study id: EBViNT
nct id: NCT03789617
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The present study is a multi-center, single-arm, open, phase I/IIa clinical trial to evaluate
      the efficacy and safety of EBViNT Cell when administered to patients with Epstein-Barr (EBV)
      positive malignancies The present study investigates with 5 parts; Part1-phase I: IP single
      therapy on ENKL and solid tumors Part2-phase I: IP + lymphodepletion on solid tumors Part
      3&5- Phase IIa: IP single therapy on each ENKL and solid tumors Part 4- Phase IIa: IP +
      lymphodepletion on solid tumors
The present study is a multi-center, single-arm, open, phase I/IIa clinical trial to evaluate
      the efficacy and safety of EBViNT Cell when administered to patients with Epstein-Barr (EBV)
      positive tumors

      After proving the safety through Part 1 and part 2, the efficacy and safety would be studied
      through part 3~5.

        -  If CTCAE grade 3 or higher adverse drug events (ADR) do not occur in the three subjects:
           Begin enrollment for phase IIa

        -  If a CTCAE grade 3 or higher ADR occurs in one of the three subjects: Enroll three more
           subjects (up to six subjects in total) and assess whether any CTCAE grade 3 or higher
           ADR occurs

             -  If a CTCAE grade 3 or higher ADR does not occur in the three additional subjects
                (1/6): Begin enrollment for phase IIa

             -  If a CTCAE grade 3 or higher ADR occurs in at least one of the three additional
                subjects (more than 2/6): Begin enrollment for phase IIa at 7.0x10^8 cells, the
                maximum dose from phase I

        -  If a CTCAE grade 3 or higher ADR occurs in two of the three subjects: Begin enrollment
           for phase IIa at 7.0x10^8 cells, the maximum dose from phase I

      Subjects participating in the present study will undergo 1) an EBV epitope screening test
      followed by 2) an eligibility assessment for clinical trial enrollment.

      Subjects who are administered with the investigational product will be monitored until
      progressive disease (PD) is confirmed or for 24 weeks (main observation period of 4 weeks +
      monitoring for 20 weeks) to evaluate the product's safety and efficacy, and will undergo
      immunological assessment.

      Radiological tests for tumor assessment will be conducted at the enrollment visit, 4 weeks, 8
      weeks, 16 weeks, and 24 weeks and assessed by the Independent Radiology Review Committee
      (IRRC) using the Lugano criteria. To eliminate pseudo-progression, progressive disease (PD)
      will be determined by considering immunological tests, a quantitative EBV DNA assay, and
      intermediate response (IR) under LYRIC. Biopsies may be performed to achieve this.
allocation: N/A
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Confirmed objective response rate (confirmed ORR) [assessed by IRRC]
time frame: up to 6 month from LPI
measure: Duration of response (DoR) [assessed by IRRC and investigator]
time frame: up to 6 month from LPI
measure: Disease control rate (DCR) [assessed by IRRC and investigator]
time frame: up to 6 month from LPI
measure: Objective response rate (ORR) [assessed by investigator]
time frame: up to 6 month from LPI
measure: Complete response rate (CR rate) [assessed by IRRC and investigator]
time frame: up to 6 month from LPI
measure: Partial response rate (PR rate) [assessed by IRRC and investigator]
time frame: up to 6 month from LPI
measure: Partial response duration (PR duration) [assessed by IRRC and investigator]
time frame: up to 6 month from LPI
measure: Progression-free survival (PFS)
time frame: up to 6 month from LPI
measure: Overall survival (OS)
time frame: up to 6 month from LPI
measure: Immunological assessment
time frame: up to 6 month
description: Plasma cytokine analysis (IL-1b, IL-2, IL-4, IL-6, IL-8, IL-10, TNF, IFN-γ, IL-17a) EBV LMP2a-specific cytokine production (IL-1b, IL-2, IL-4, IL-6, IL-8, IL-10, TNF, IFN-γ, IL-17a) Phenotypical analysis of CD8 T cells
measure: Quantitative EBV DNA assay
time frame: up to 6 month
arm group label: EBViNT Cell
arm group type: Experimental
intervention type: Biological
intervention name: EBViNT Cell
description: Dosage: 1 bag containing 1.4x10^9 cells/100mL
Administration: Inject intravenously over 30 minutes
Dosing schedule: Single dose
arm group label: EBViNT Cell
other name: Eutil autologous blood-derived T lymphocytes
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Hyeon Seok Eom, MD
role: Principal Investigator
affiliation: National Cancer Center
last name: Won Seog Kim, MD
role: Principal Investigator
affiliation: Samsung Medical Center
last name: Ho Jin Shin, MD
role: Principal Investigator
affiliation: Pusan National University Hospital
last name: Min-hee Ryu, MD
role: Principal Investigator
affiliation: Asan Medical Cente
last name: Won Sik Lee, MD
role: Principal Investigator
affiliation: Inje University
last name: Minsuk Kwon, MD
role: Principal Investigator
affiliation: Ajou Univ. Hosp.
last name: Hyo song Kim, MD
role: Principal Investigator
affiliation: Severance Hosp
last name: Jeeyun Lee, MD
role: Principal Investigator
affiliation: Samsung Medical Center
last name: Sehee Hwang
phone: +82-2-2071-3310
email: hsh0820@eutilex.com
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status: Not yet recruiting
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country: Korea, Republic of
url: http://www.eutilex.com/en/
description: Web address
citation: Eom HS, Choi BK, Lee Y, Lee H, Yun T, Kim YH, Lee JJ, Kwon BS. Phase I Clinical Trial of 4-1BB-based Adoptive T-Cell Therapy for Epstein-Barr Virus (EBV)-positive Tumors. J Immunother. 2016 Apr;39(3):140-8. doi: 10.1097/CJI.0000000000000113.
PMID: 26938947
citation: Choi BK, Lee SC, Lee MJ, Kim YH, Kim YW, Ryu KW, Lee JH, Shin SM, Lee SH, Suzuki S, Oh HS, Kim CH, Lee DG, Hwang SH, Yu EM, Lee IO, Kwon BS. 4-1BB-based isolation and expansion of CD8+ T cells specific for self-tumor and non-self-tumor antigens for adoptive T-cell therapy. J Immunother. 2014 May;37(4):225-36. doi: 10.1097/CJI.0000000000000027.
PMID: 24714356
responsible party type: Sponsor
mesh term: Epstein-Barr Virus Infections
mesh term: Adenocarcinoma
mesh term: Lymphoma, Extranodal NK-T-Cell
sharing ipd: No