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Status unknownNCT03671850Updated Apr 29, 2022

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

A Phase 2 interventional study of VT-EBV-N and Placebo in Extranodal NK/T-cell Lymphoma, sponsored by ViGenCell Inc.. Status unknown at 8 sites in Korea, Republic of. Open to participants aged 19 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-04-29.

Sponsored by ViGenCell Inc. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
19 Years to 75 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's planned enrollment of 48 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

ViGenCell Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    VT-EBV-N

    Epstein-barr virus human cytotoxic T lymphocytes (EBV-CTL)

    Biological: VT-EBV-N

  • Placebo comparator
    Placebo

    Peripheral blood mononuclear cell, PBMC

    Other: Placebo

Interventions

  • BiologicalVT-EBV-N

    Epstein-barr virus human cytotoxic T lymphocytes (EBV-CTL)

  • OtherPlacebo

    Peripheral blood mononuclear cell, PBMC

06

What researchers measure

Primary outcomes

  1. No relapse or death due to any reason after randomization

    Time frame: Randomization (8 weeks before administration) ~ 116 weeks after treatment period

Secondary outcomes

  1. No death after randomization

    Time frame: Randomization (8 weeks before administration) ~ 116 weeks after treatment period

  2. No relapse or death due to any reason after randomization

    Time frame: Randomization (116 weeks after treatment period) ~

07

Study locations

8 of 8 sites recruiting
  • Inje University Busan Paik Hospital
    Busan, 47392, Korea, Republic of
    • Won-Sik Lee, M.D., Ph.D · Contact
    Recruiting
  • Keimyung University Daegu Dongsan Hospital
    Daegu, 41931, Korea, Republic of
    • YoungRok Do, M.D., Ph.D · Contact
    Recruiting
  • Hallym Univ. Medical Center
    Gyeonggi-do, 14068, Korea, Republic of
    • Hyo Jung Kim, M.D., Ph.D · Contact
    Recruiting
  • Chonnam National University Hwasun Hospital
    Hwasun, 58128, Korea, Republic of
    • Deok-Hwan Yang, M.D., Ph.D · Contact
    Recruiting
  • Seoul National University Hospital
    Seoul, 03080, Korea, Republic of
    • Inho Kim, M.D., Ph.D · Contact
    Recruiting
  • Severance Hospital
    Seoul, 03722, Korea, Republic of
    • Jinseok Kim, M.D., Ph.D · Contact
    Recruiting
  • Konkuk University Medical Center
    Seoul, 05030, Korea, Republic of
    • Sung-Yong Kim, M.D., Ph.D · Contact
    Recruiting
  • Seoul St.Mary's Hospital
    Seoul, KS013, Korea, Republic of
    • Seok-Goo Cho, M.D., Ph.D) · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03671850
Lead sponsor
ViGenCell Inc.
Responsible party
Sponsor
First posted
Sep 14, 2018
Start date
Apr 9, 2019
Primary completion
Dec 4, 2023 (estimated)
Completion
Jun 3, 2024 (estimated)
Last update
Apr 29, 2022

Study contacts

Dae-Hee Sohn
Contact
goriest@vigencell.com
82-70-4348-7527
Hyun-Jung Sohn
Contact
sohnhj@vigencell.com
82-70-4348-7527
Seok-Goo Cho
principal investigator · The Catholic University of Korea

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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