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EBV Associated Extranodal NK/T-cell LymphomaPhase 1/2NCT03789617

A Multi-center, Single-arm, Open, Phase I/IIa Clinical Trial to Evaluate the Efficacy and Safety of EBViNT Cell (EBV Specific Autologous CD8+ T Cell) in Patients With Treatment Failed Epstein Barr Virus (EBV)-Positive Malignancies

A Phase 1/2 study testing EBViNT Cell in people with EBV Associated Extranodal NK/T-cell Lymphoma and EBV-Associated GastricCarcinoma or Esophageal AdenoCarcinoma, run by Eutilex at 8 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The present study is a multi-center, single-arm, open, phase I/IIa clinical trial to evaluate the efficacy and safety of EBViNT Cell when administered to patients with Epstein-Barr (EBV) positive malignancies The present study investigates with 5 parts; Part1-phase I: IP single therapy on ENKL and solid tumors… Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
EBViNT Cell
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
8 sitesSouth Korea
Study dates
14 Dec 2018to Dec 2024
Phase
Phase 1/2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least 19 years of age
  • Patients with lymphomas or solid tumors who have been found to be positive for EBV encoded RNA (EBER) by in situ hybridization (ISH) (previous test results may be used as evidence if available)
  • Part 1: Histologically or cytologically confirmed lymphoma or solid tumor
  • Part 2: Histologically or cytologically confirmed solid tumor
  • Part 3: Patients who have been diagnosed with histologically confirmed extranodal NK/T-cell lymphoma (ENKL) according to WHO classification
  • Parts 4 and 5: Patients with histologically confirmed gastric cancer or esophageal adenocarcinoma
  • Patients who have given written consent to voluntarily participate in the epitope screening

Who cannot join

  • Patients with aggressive NK cell leukemia
  • Patients with hemophagocytic lymphohistiocytosis (HLH)
  • Persons who have previously received a solid organ transplant
  • Persons who have been diagnosed with a malignant tumor other than the target disease in the past 5 years (treated basal cell carcinoma, squamous epithelial cell carcinoma, and non-invasive cervical cancer do not necessitate exclusion)
  • Patients in whom a tuberculosis infection was confirmed in the 1 year prior to screening for the present study (However, patients who have been determined to be cured after treatment may be enrolled.)
  • Patients who test positive for anti-HIV antibodies
Show all 25Show fewer
  • Patients deemed unsuitable to participate in the clinical trial by an investigator based on active infection (HBV, HCV) test results
  • Enrollment Criteria (Visit 2)
  • Persons who have been found to be capable of production in the epitope screening test
  • Patients who have failed standard treatment or conventional chemotherapy and who meet any one of the following
  • Patients who have relapsed/progressed after 1 or more chemotherapies, and for whom standard treatment does not exist or cannot be performed
  • Intolerable patients for whom anticancer treatment cannot be performed or a minimum of one full cycle cannot be completed in a first-line chemotherapy
  • Patients who are refractory to first-line chemotherapy
  • Persons with evaluable lesions
  • Lymphoma: Persons with at least 1 lesion with long axis > 15 mm or 18FDG-PET-CT avid
  • Solid tumor: Persons with at least 1 measurable lesion based on RECIST 1.1
  • Persons with appropriate liver, renal, and bone marrow function (two retests are permitted for borderline results, and corrections such as transfusion are permitted)
  • Where central nervous system (CNS) lymphoma or uncontrolled CNS metastasis is present (patients with brain metastasis that has been treated and is stable [stable for at least 30 days based on radiology records] may be enrolled)
  • Persons who have received surgery, radiotherapy, or chemotherapy in the 3 weeks prior to the investigational product administration
  • Persons who have been administered any other investigational product in the 3 weeks prior to the investigational product administration
  • Persons who have not recovered from the toxicity of any previous treatment to Grade 1 or lower based on NCI CTCAE v5.0 (however, clinically insignificant toxicities such as alopecia are excluded)
  • Patients who have received immunosuppressants, including steroids, in the 10 days prior to blood collection (Visit 2) for production of the study drug (however, local steroids and steroids for inhalers are permitted, and steroid equivalent to 20 mg/day of prednisolone may be administered at the investigator's discretion)
  • Patients with the following (but not limited to) clinically significant cardiovascular comorbidities as determined by the investigator
  • : Uncontrolled hypertension (i.e., systolic pressure > 180 mmHg and/or diastolic pressure > 100 mm/Hg), unstable angina, pulmonary embolism, cerebrovascular disease, valvular disease, congestive heart failure (NYHA severity classification Grade III or IV), or myocardial infarction or serious cardiac arrhythmia within the 24 weeks prior to the enrollment visit
  • Patients with findings of autoimmune or inflammatory disease, whose abnormal results from an autoimmune response test have been deemed clinically significant by an investigator

Trial locations and contacts

8 sites in 1 country.

Sehee Hwang contact

+82-2-2071-3310

hsh0820@eutilex.com

8 sites in 1 country

South Korea8 sites, 8 recruiting

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408

    Hyeon Seok Eom, Dr, 82319201165

    Not yet recruiting

  • Inje Univ. Hosp

    Pusan

    Won Sik Lee, MD, PhD

    Not yet recruiting

  • Pusan national Univ. Hosp.

    Pusan

    Ho Jin Shin, MD, PhD

    Recruiting

  • Samsung Medical Center

    Seoul, Gangnam-gu, 06351

    Won Seog Kim, Dr, 82221487390

    Not yet recruiting

  • Samsung Medical Center

    Seoul

    Jeeyun Lee, MD, PhD

    Not yet recruiting

  • Seoul Asan Medical center

    Seoul

    Min-hee Ryu, MD, PhD

    Not yet recruiting

  • Severance hosp.

    Seoul

    Hyo Song Kim, MD, PhD

    Not yet recruiting

  • Ajou Univ Hosp.

    Suwon

    Minsuk Kwon, MD, PhD

    Not yet recruiting

Other trials in South Korea

About this study

The present study is a multi-center, single-arm, open, phase I/IIa clinical trial to evaluate the efficacy and safety of EBViNT Cell when administered to patients with Epstein-Barr (EBV) positive malignancies The present study investigates with 5 parts; Part1-phase I: IP single therapy on ENKL and solid tumors Part2-phase I: IP + lymphodepletion on solid tumors Part 3\&5- Phase IIa: IP single therapy on each ENKL and solid tumors Part 4- Phase IIa: IP + lymphodepletion on solid tumors

Read the detailed description

The present study is a multi-center, single-arm, open, phase I/IIa clinical trial to evaluate the efficacy and safety of EBViNT Cell when administered to patients with Epstein-Barr (EBV) positive tumors

After proving the safety through Part 1 and part 2, the efficacy and safety would be studied through part 3~5.

  • If CTCAE grade 3 or higher adverse drug events (ADR) do not occur in the three subjects: Begin enrollment for phase IIa
  • If a CTCAE grade 3 or higher ADR occurs in one of the three subjects: Enroll three more subjects (up to six subjects in total) and assess whether any CTCAE grade 3 or higher ADR occurs
  • If a CTCAE grade 3 or higher ADR does not occur in the three additional subjects (1/6): Begin enrollment for phase IIa
  • If a CTCAE grade 3 or higher ADR occurs in at least one of the three additional subjects (more than 2/6): Begin enrollment for phase IIa at 7.0x10^8 cells, the maximum dose from phase I
  • If a CTCAE grade 3 or higher ADR occurs in two of the three subjects: Begin enrollment for phase IIa at 7.0x10^8 cells, the maximum dose from phase I

Subjects participating in the present study will undergo 1) an EBV epitope screening test followed by 2) an eligibility assessment for clinical trial enrollment.

Subjects who are administered with the investigational product will be monitored until progressive disease (PD) is confirmed or for 24 weeks (main observation period of 4 weeks + monitoring for 20 weeks) to evaluate the product's safety and efficacy, and will undergo immunological assessment.

Radiological tests for tumor assessment will be conducted at the enrollment visit, 4 weeks, 8 weeks, 16 weeks, and 24 weeks and assessed by the Independent Radiology Review Committee (IRRC) using the Lugano criteria. To eliminate pseudo-progression, progressive disease (PD) will be determined by considering immunological tests, a quantitative EBV DNA assay, and intermediate response (IR) under LYRIC. Biopsies may be performed to achieve this.

Being tested
EBViNT Cell
Keywords
Cytotoxic T cell, Lymphoma, Immuno-oncology, ENKL, EBViNT, Gastric cancer, solid tumor, Esophageal AdenoCarcinoma
Medical subject headings
Adenocarcinoma Of Esophagus, Lymphoma, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EBViNT CellBiological

    Also called Eutil autologous blood-derived T lymphocytes

    1. Dosage: 1 bag containing 1.4x10^9 cells/100mL
    2. Administration: Inject intravenously over 30 minutes
    3. Dosing schedule: Single dose
Study groups in NCT03789617
Study groupRoleWhat they receive
EBViNT CellExperimentalNot described
Receives: Biological: EBViNT Cell

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Confirmed objective response rate (confirmed ORR) [assessed by IRRC]

    Measured: up to 6 month from LPI

Secondary outcomes (8)

  1. Duration of response (DoR) [assessed by IRRC and investigator]

    Measured: up to 6 month from LPI

  2. Disease control rate (DCR) [assessed by IRRC and investigator]

    Measured: up to 6 month from LPI

  3. Objective response rate (ORR) [assessed by investigator]

    Measured: up to 6 month from LPI

  4. Complete response rate (CR rate) [assessed by IRRC and investigator]

    Measured: up to 6 month from LPI

  5. Partial response rate (PR rate) [assessed by IRRC and investigator]

    Measured: up to 6 month from LPI

  6. Partial response duration (PR duration) [assessed by IRRC and investigator]

    Measured: up to 6 month from LPI

  7. Progression-free survival (PFS)

    Measured: up to 6 month from LPI

  8. Overall survival (OS)

    Measured: up to 6 month from LPI

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2018
  2. Study start14 Dec 2018
  3. Primary completionSep 2022 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03789617
Sponsor's protocol ID
EBViNT
Status last verified
Apr 2022
First submitted
27 Dec 2018
Last updated
11 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Eom HS, Choi BK, Lee Y, Lee H, Yun T, Kim YH, Lee JJ, Kwon BS. Phase I Clinical Trial of 4-1BB-based Adoptive T-Cell Therapy for Epstein-Barr Virus (EBV)-positive Tumors. J Immunother. 2016 Apr;39(3):140-8. doi: 10.1097/CJI.0000000000000113.

    PubMed 26938947

  • Choi BK, Lee SC, Lee MJ, Kim YH, Kim YW, Ryu KW, Lee JH, Shin SM, Lee SH, Suzuki S, Oh HS, Kim CH, Lee DG, Hwang SH, Yu EM, Lee IO, Kwon BS. 4-1BB-based isolation and expansion of CD8+ T cells specific for self-tumor and non-self-tumor antigens for adoptive T-cell therapy. J Immunother. 2014 May;37(4):225-36. doi: 10.1097/CJI.0000000000000027.

    PubMed 24714356

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing EBViNT Cell in people with EBV Associated Extranodal NK/T-cell Lymphoma and EBV-Associated GastricCarcinoma or Esophageal AdenoCarcinoma, run by Eutilex 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 7 inclusion and 25 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 11 Jul 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 Sehee Hwang (+82-2-2071-3310, hsh0820@eutilex.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confirmed objective response rate (confirmed ORR) [assessed by IRRC] (time frame: up to 6 month from LPI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03789617, which also lists 2 linked publications.

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 11 Jul 2022.

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