Clinical Trials /

VT-EBV-N for Treatment of Severe in EBV Positive Extranodal NK/T Cell Lymphoma Patients

NCT03671850

Description:

The study aims to evaluate the efficacy and safety of VT-EBV-N (EBV-CTL) administration in ENKL patients after complete remission (CR). This is to prove the effect of VT-EBV-N (EBV-CTL) in prevention of ENKL relapse compared to placebo, by checking the primary endpoint of DFS rate (disease free survival, no relapse or death after randomization) at 2 years (103 weeks) for the last subject enrolled. 50% of the subjects will be administered VT-EBV-N (EBV-CTL), while the remaining subjects will be administered a placebo.

Related Conditions:
  • Nasal Type Extranodal NK/T-Cell Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: VT-EBV-N for Treatment of Severe in EBV Positive Extranodal NK/T Cell Lymphoma Patients
  • Official Title: A Phase 2 Study to Evaluate the Efficacy and Safety of Postremission Therapy Using VT-EBV-N in EBV Positive Extranodal NK/T Cell Lymphoma Patients

Clinical Trial IDs

  • ORG STUDY ID: VT-EBV-201
  • NCT ID: NCT03671850

Conditions

  • Extranodal NK/T-cell Lymphoma

Interventions

DrugSynonymsArms
VT-EBV-NVT-EBV-N

Purpose

The study aims to evaluate the efficacy and safety of VT-EBV-N (EBV-CTL) administration in ENKL patients after complete remission (CR). This is to prove the effect of VT-EBV-N (EBV-CTL) in prevention of ENKL relapse compared to placebo, by checking the primary endpoint of DFS rate (disease free survival, no relapse or death after randomization) at 2 years (103 weeks) for the last subject enrolled. 50% of the subjects will be administered VT-EBV-N (EBV-CTL), while the remaining subjects will be administered a placebo.

Detailed Description

      NK/T-cell lymphoma is a malignant tumor originating in NK cells and T lymphocytes. ENKL is
      associated with Epstein-Barr virus (EBV) infection and typically occurs in the nasal area,
      being termed ENKL, nasal type.EBV is a common virus in the herpes family. EBV infection in
      patients with lowered immunity such as those with Acquired Immune Deficiency Syndrome or
      those taking immunosuppressants after bone marrow transplant may induce lymphoproliferative
      diseases or cancer.

      VT-EBV-N (EBV-CTL) is a cytotoxicity T lymphocyte (CTL) targeting EBV expressed tumor cells
      indicated for ENKL. Antigen-presenting cells derived from the patient's own blood is used to
      activate T-cells in a test tube to recognize EBV, which are then expanded in vitro and
      infused into the patient's body. Targeted immunotherapy using EBV-CTL is a safe form of
      treatment that can improve long-term disease-free survival rates by boosting antitumor
      immunity without affecting other tissues apart from tumor cells.
    

Trial Arms

NameTypeDescriptionInterventions
VT-EBV-NExperimentalEpstein-barr virus human cytotoxic T lymphocytes (EBV-CTL)
  • VT-EBV-N
PlaceboPlacebo ComparatorPeripheral blood mononuclear cell, PBMC

    Eligibility Criteria

            Inclusion Criteria:
    
              1. EBV positive extranodal NK/T cell lymphoma (ENKL) patients pathologically confirmed
                 according to WHO classification at first diagnosis
    
              2. Patients whose complete remission (CR) has been confirmed within 6 months before
                 screening and maintained, presenting high risk of relapse due to one or more of the
                 following 1) Patients who are EBV detectable at initial diagnosis, with one or more of
                 the following high risk factors 60 years of age or older, Ann Arbor stage II ~ IV,
                 non-nasal type disease, local invasiveness (defined with T3 or T4), elevated LDH (>
                 upper limit of normal)) 2) Patients confirmed to have EBV DNAemia (> 2000 copies/ml)
                 during or after treatment 3) Patients who achieved remission from secondary or greater
                 remission induction therapy after the failure of primary remission induction, or
                 achieved remission after relapse
    
              3. 19 years and above to 75 years and below
    
              4. Patients with ECOG performance criteria score of 0 to 2
    
              5. Patients with acceptable hematopoietic function (ANC ≥ 1.5 x 109 /L, PLT ≥ 100 x 109
                 /L, Hb ≥ 9 g/dL)
    
              6. Patients with acceptable liver function (total bilirubin < 2 x upper limit of normal,
                 AST/ALT < 3 x upper limit of normal)
    
              7. Patients with renal function of eGFR > 50 or better
    
              8. Patients with life expectancy of 6 or longer
    
              9. Patients who have agreed to use two different types of birth control during the study
                 period (Females of childbearing age or within 2 years after menopause have to show
                 negative results in urine pregnancy test) (E.g., dual contraception using oral
                 contraceptives, contraceptive implant, contraceptive injection, or contraceptive patch
                 combined with intrauterine device, spermicide foam or gel, contraceptive film, vaginal
                 diaphragm, cervical cap, condom, etc.)
    
             10. Patients who have voluntarily given written consent to participate in this study
    
            Exclusion Criteria:
    
              1. Other pathological classifications of nasal cavity lymphoma than ENKL at initial
                 diagnosis
    
              2. Patients with ENKL that has invaded the central nervous system
    
              3. Patients in PR, SD or PD state, not complete remission (CR)
    
              4. Patients who cannot generate EBV-CTL
    
              5. Patients who have received allogeneic stem cell transplantations
    
              6. Patients with severe or uncontrolled medical disorders(diabetes exceeding HbA1C9%,
                 severe hypertension exceeding 180/110 mmHg, heart failure of NYHA class Ⅲ or Ⅳ,
                 myocardial infarction diagnosed within 6 months prior to screening)
    
              7. Patients with apparent infection (HIV infection, chronic hepatitis B, chronic
                 hepatitis C, active tuberculosis, etc.)
    
              8. Patients with malignant tumors or previous history of malignant tumors except
                 completely recovered non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma
    
              9. Patients currently receiving treatment for ENKL such as chemotherapy, hormone therapy,
                 or immunotherapy
    
             10. Patients with hypersensitivity to the investigational product or pretreatment
                 products, including cryoprotectants
          
    Maximum Eligible Age:75 Years
    Minimum Eligible Age:19 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:No relapse or death due to any reason after randomization
    Time Frame:Randomization (8 weeks before administration) ~ 116 weeks after treatment period
    Safety Issue:
    Description:

    Secondary Outcome Measures

    Measure:No death after randomization
    Time Frame:Randomization (8 weeks before administration) ~ 116 weeks after treatment period
    Safety Issue:
    Description:
    Measure:No relapse or death due to any reason after randomization
    Time Frame:Randomization (116 weeks after treatment period) ~
    Safety Issue:
    Description:

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:ViGenCell Inc.

    Last Updated