VT-EBV-N for Treatment of Severe in EBV Positive Extranodal NK/T Cell Lymphoma Patients
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.
Timeline
- Start
- 2019-04-09
- Primary completion
- 2023-12-04
- Completion
- 2024-06-03
Outcome
Met primary endpoint
release “바이젠셀, VT-EBV-N 임상2상 통계적 유의성 확보 - 1차평가지표 2년 무질병생존(DFS)에서 투여군과 대조군의 유의미한 차이 확인” vigencell.com ↗
release “‘VT-EBV-N’은 NK/T세포림프종 대상 무작위배정·이중맹검 임상 2상에서 유의미한 치료 효과를 확인하며 기술력을 입증했다.” vigencell.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VT-EBV-N | Cell therapy | — | — |