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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VT-EBV-N | Experimental | Epstein-barr virus human cytotoxic T lymphocytes (EBV-CTL) |
|
| Placebo | Placebo Comparator | Peripheral blood mononuclear cell, PBMC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VT-EBV-N | Biological | Epstein-barr virus human cytotoxic T lymphocytes (EBV-CTL) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| No relapse or death due to any reason after randomization | Randomization (8 weeks before administration) ~ 116 weeks after treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| No death after randomization | Randomization (8 weeks before administration) ~ 116 weeks after treatment period | |
| No relapse or death due to any reason after randomization | Randomization (116 weeks after treatment period) ~ |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dae-Hee Sohn | Contact | 82-70-4348-7527 | goriest@vigencell.com | |
| Hyun-Jung Sohn | Contact | 82-70-4348-7527 | sohnhj@vigencell.com |
| Name | Affiliation | Role |
|---|---|---|
| Seok-Goo Cho | The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inje University Busan Paik Hospital | Recruiting | Busan | 47392 | South Korea |
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| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
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| Placebo |
| Other |
Peripheral blood mononuclear cell, PBMC |
|
| Keimyung University Daegu Dongsan Hospital | Recruiting | Daegu | 41931 | South Korea |
|
| Hallym Univ. Medical Center | Recruiting | Gyeonggi-do | 14068 | South Korea |
|
| Chonnam National University Hwasun Hospital | Recruiting | Hwasun | 58128 | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
|
| Severance Hospital | Recruiting | Seoul | 03722 | South Korea |
|
| Konkuk University Medical Center | Recruiting | Seoul | 05030 | South Korea |
|
| Seoul St.Mary's Hospital | Recruiting | Seoul | KS013 | South Korea |
|
| D009369 |
| Neoplasms |