Clinical Trials Logo
  1. Home
  2. Extranodal NK/T-cell Lymphoma
  3. NCT03671850

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

Extranodal NK/T-cell Lymphoma Clinical Trial

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 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03671850
Study type Interventional
Source ViGenCell Inc.
Contact Dae-Hee Sohn
Phone 82-70-4348-7527
Email goriest@vigencell.com
Status Recruiting
Phase Phase 2
Start date April 9, 2019
Completion date June 3, 2024
View Details
See also
  Status Clinical Trial Phase
Active, not recruiting NCT04526834 - Phase 1 Study of Autologous CD30.CAR-T in Relapsed or Refractory CD30 Positive Non-Hodgkin Lymphoma Phase 1
Recruiting NCT05377827 - Dose-Escalation and Dose-Expansion Study to Evaluate the Safety and Tolerability of Anti-CD7 Allogeneic CAR T-Cells (WU-CART-007) in Patients With CD7+ Hematologic Malignancies Phase 1
Recruiting NCT04917250 - GPED for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma Phase 2
Not yet recruiting NCT04337593 - Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL Phase 2
Active, not recruiting NCT04414163 - A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T Cell Lymphoma, Nasal Type Phase 2
Not yet recruiting NCT05700448 - Study of Sugemalimab (or Placebo) Plus PGemOx Regimen in Participants With Extranodal NK/T-Cell Lymphoma Phase 3
Completed NCT03246750 - B-MAD Chemotherapy in Newly-diagnosed Extranodal NK/ T-cell Lymphoma Phase 1/Phase 2
Not yet recruiting NCT03598959 - Tofacitinib Combined With Chidamide in R/R ENKTCL Phase 2
Recruiting NCT00725231 - Immunotherapy in Peripheral T Cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP Phase 3
Recruiting NCT04554511 - Prognostic Nomogram of Extranodal NK/T-cell Lymphoma
Completed NCT03493451 - Study of BGB-A317 in Participants With Relapsed or Refractory Mature T- and NK-cell Neoplasms Phase 2
Recruiting NCT04279379 - Sintilimab and Decitabine for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma Phase 2
No longer available NCT05131438 - An Expanded Access Program to Provide Sugemalimab for the Treatment of Relapsed or Refractory Extranodal Natural Killer/T-Cell Lymphoma (R/R ENKTL)