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 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.
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 →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.
Exclusion Criteria:
Epstein-barr virus human cytotoxic T lymphocytes (EBV-CTL)
Biological: VT-EBV-N
Peripheral blood mononuclear cell, PBMC
Other: Placebo
Epstein-barr virus human cytotoxic T lymphocytes (EBV-CTL)
Peripheral blood mononuclear cell, PBMC
No relapse or death due to any reason after randomization
Time frame: Randomization (8 weeks before administration) ~ 116 weeks after treatment period
No death after randomization
Time frame: Randomization (8 weeks before administration) ~ 116 weeks after treatment period
No relapse or death due to any reason after randomization
Time frame: Randomization (116 weeks after treatment period) ~
Plan to share: No
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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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ViGenCell Inc.