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

NCT03671850 | Unknown Phase 2

• 1 other identifier: VT-EBV-201
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Extranodal NK/T-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• No relapse or death due to any reason after randomization

  Randomization (8 weeks before administration) ~ 116 weeks after treatment period

Secondary Outcomes (2)

• 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) ~

Study Arms (2)

VT-EBV-N

EXPERIMENTAL

Epstein-barr virus human cytotoxic T lymphocytes (EBV-CTL)

Biological: VT-EBV-N

Placebo

PLACEBO COMPARATOR

Peripheral blood mononuclear cell, PBMC

Other: Placebo

Interventions

VT-EBV-N BIOLOGICAL

Epstein-barr virus human cytotoxic T lymphocytes (EBV-CTL)

VT-EBV-N

Placebo OTHER

Peripheral blood mononuclear cell, PBMC

Placebo

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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)
• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• ViGenCell Inc.: lead

Study Sites (8)

Inje University Busan Paik Hospital

Busan, 47392, South Korea

RECRUITING

Keimyung University Daegu Dongsan Hospital

Daegu, 41931, South Korea

RECRUITING

Hallym Univ. Medical Center

Gyeonggi-do, 14068, South Korea

RECRUITING

Chonnam National University Hwasun Hospital

Hwasun, 58128, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Konkuk University Medical Center

Seoul, 05030, South Korea

RECRUITING

Seoul St.Mary's Hospital

Seoul, KS013, South Korea

RECRUITING

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Seok-Goo Cho

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dae-Hee Sohn

CONTACT

82-70-4348-7527; goriest@vigencell.com

Hyun-Jung Sohn

CONTACT

82-70-4348-7527; sohnhj@vigencell.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2018
• First Posted: September 14, 2018
• Study Start: April 9, 2019
• Primary Completion: December 4, 2023
• Study Completion: June 3, 2024
• Last Updated: April 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (8)