Extranodal NK/T-cell LymphomaPhase 2NCT03671850
VT-EBV-N for Treatment of Severe in EBV Positive Extranodal NK/T Cell Lymphoma Patients
A Phase 2 study testing VT-EBV-N in people with Extranodal NK/T-cell Lymphoma, run by ViGenCell Inc. at 8 sites in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Extranodal NK/T-cell Lymphoma
- What is being tested?
- VT-EBV-N
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 9 Apr 2019to 3 Jun 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- EBV positive extranodal NK/T cell lymphoma (ENKL) patients pathologically confirmed according to WHO classification at first diagnosis
- 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
- 19 years and above to 75 years and below
- Patients with ECOG performance criteria score of 0 to 2
- Patients with acceptable hematopoietic function (ANC ≥ 1.5 x 109 /L, PLT ≥ 100 x 109 /L, Hb ≥ 9 g/dL)
- Patients with acceptable liver function (total bilirubin < 2 x upper limit of normal, AST/ALT < 3 x upper limit of normal)
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- Patients with renal function of eGFR > 50 or better
- Patients with life expectancy of 6 or longer
- 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.)
- Patients who have voluntarily given written consent to participate in this study
Who cannot join
- Other pathological classifications of nasal cavity lymphoma than ENKL at initial diagnosis
- Patients with ENKL that has invaded the central nervous system
- Patients in PR, SD or PD state, not complete remission (CR)
- Patients who cannot generate EBV-CTL
- Patients who have received allogeneic stem cell transplantations
- 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)
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- Patients with apparent infection (HIV infection, chronic hepatitis B, chronic hepatitis C, active tuberculosis, etc.)
- Patients with malignant tumors or previous history of malignant tumors except completely recovered non-melanoma skin cancer or stage 0 (in situ) cervical carcinoma
- Patients currently receiving treatment for ENKL such as chemotherapy, hormone therapy, or immunotherapy
- Patients with hypersensitivity to the investigational product or pretreatment products, including cryoprotectants
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites, 8 recruiting
- Recruiting
Inje University Busan Paik Hospital
Busan, 47392
Won-Sik Lee, M.D., Ph.D
- Recruiting
Keimyung University Daegu Dongsan Hospital
Daegu, 41931
YoungRok Do, M.D., Ph.D
- Recruiting
Hallym Univ. Medical Center
Gyeonggi-do, 14068
Hyo Jung Kim, M.D., Ph.D
- Recruiting
Chonnam National University Hwasun Hospital
Hwasun, 58128
Deok-Hwan Yang, M.D., Ph.D
- Recruiting
Seoul National University Hospital
Seoul, 03080
Inho Kim, M.D., Ph.D
- Recruiting
Severance Hospital
Seoul, 03722
Jinseok Kim, M.D., Ph.D
- Recruiting
Konkuk University Medical Center
Seoul, 05030
Sung-Yong Kim, M.D., Ph.D
- Recruiting
Seoul St.Mary's Hospital
Seoul, KS013
Seok-Goo Cho, M.D., Ph.D)
About this study
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
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.
- Conditions
- Extranodal NK/T-cell Lymphoma
- Being tested
- VT-EBV-N, Placebo
- Medical subject headings
- Lymphoma, Extranodal NK-T-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VT-EBV-NBiological
Epstein-barr virus human cytotoxic T lymphocytes (EBV-CTL)
PlaceboOther
Peripheral blood mononuclear cell, PBMC
| Study group | Role | What they receive |
|---|---|---|
| VT-EBV-N | Experimental | Epstein-barr virus human cytotoxic T lymphocytes (EBV-CTL) Receives: Biological: VT-EBV-N |
| Placebo | Placebo comparator | Peripheral blood mononuclear cell, PBMC Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
No relapse or death due to any reason after randomization
Measured: Randomization (8 weeks before administration) ~ 116 weeks after treatment period
Secondary outcomes (2)
No death after randomization
Measured: Randomization (8 weeks before administration) ~ 116 weeks after treatment period
No relapse or death due to any reason after randomization
Measured: Randomization (116 weeks after treatment period) ~
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start9 Apr 2019
- Primary completion4 Dec 2023 (estimated)
- Study completion3 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extranodal NK/T-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ViGenCell Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seok-Goo Cho, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671850
- Sponsor's protocol ID
- VT-EBV-201
- Status last verified
- Mar 2022
- First submitted
- 12 Sep 2018
- Last updated
- 29 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03671850
- Acronym / sponsor ID
- VT-EBV-201
- Conditions
- Extranodal NK/T-cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- ViGenCell Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2019 (actual)
- Primary completion
- 4 Dec 2023 (estimated)
- Study completion
- 3 Jun 2024 (estimated)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VT-EBV-N | Experimental | Biological: VT-EBV-NEpstein-barr virus human cytotoxic T lymphocytes (EBV-CTL) |
| Placebo | Placebo comparator | Other: PlaceboPeripheral blood mononuclear cell, PBMC |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- EBV positive extranodal NK/T cell lymphoma (ENKL) patients pathologically confirmed according to WHO classification at first diagnosis
- 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
- 19 years and above to 75 years and below
- Patients with ECOG performance criteria score of 0 to 2
- Patients with acceptable hematopoietic function (ANC ≥ 1.5 x 109 /L, PLT ≥ 100 x 109 /L, Hb ≥ 9 g/dL)
Key exclusion criteria (10 listed)
- Other pathological classifications of nasal cavity lymphoma than ENKL at initial diagnosis
- Patients with ENKL that has invaded the central nervous system
- Patients in PR, SD or PD state, not complete remission (CR)
- Patients who cannot generate EBV-CTL
- Patients who have received allogeneic stem cell transplantations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VT-EBV-NEpstein-barr virus human cytotoxic T lymphocytes (EBV-CTL) | Biological | VT-EBV-N |
| PlaceboPeripheral blood mononuclear cell, PBMC | Other | Placebo |
Primary outcome
No relapse or death due to any reason after randomization
Time frame: Randomization (8 weeks before administration) ~ 116 weeks after treatment period
2 secondary outcomes
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) ~
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seok-Goo Cho principal investigator
The Catholic University of Korea
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VT-EBV-N in people with Extranodal NK/T-cell Lymphoma, run by ViGenCell Inc. at 8 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dae-Hee Sohn (82-70-4348-7527, goriest@vigencell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
No relapse or death due to any reason after randomization (time frame: Randomization (8 weeks before administration) ~ 116 weeks after treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.