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

NCT03789617 | Unknown Phase 1

• 1 other identifier: EBViNT
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 8

Brief 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 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

Conditions

EBV Associated Extranodal NK/T-cell Lymphoma; EBV-Associated GastricCarcinoma or Esophageal AdenoCarcinoma

Keywords

Cytotoxic T cell; Lymphoma; Immuno-oncology; ENKL; EBViNT; Gastric cancer; solid tumor; Esophageal AdenoCarcinoma

Outcome Measures

Primary Outcomes (1)

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

  up to 6 month from LPI

Secondary Outcomes (8)

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

  up to 6 month from LPI

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

  up to 6 month from LPI

• Objective response rate (ORR) [assessed by investigator]

  up to 6 month from LPI

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

  up to 6 month from LPI

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

  up to 6 month from LPI

Other Outcomes (2)

• Immunological assessment

  up to 6 month

• Quantitative EBV DNA assay

  up to 6 month

Study Arms (1)

EBViNT Cell

EXPERIMENTAL

Biological: EBViNT Cell

Interventions

EBViNT Cell BIOLOGICAL

1. Dosage: 1 bag containing 1.4x10\^9 cells/100mL 2. Administration: Inject intravenously over 30 minutes 3. Dosing schedule: Single dose

Also known as: Eutil autologous blood-derived T lymphocytes

EBViNT Cell

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Patients with aggressive NK cell leukemia
• Patients with hemophagocytic lymphohistiocytosis (HLH)
• Persons who have previously received a solid organ transplant
• 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
• 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

Sponsors & Collaborators

• Eutilex: lead

Study Sites (8)

Samsung Medical Center

Seoul, Gangnam-gu, 06351, South Korea

NOT YET RECRUITING

National Cancer Center

Goyang-si, Gyeonggi-do, 10408, South Korea

NOT YET RECRUITING

Inje Univ. Hosp

Pusan, South Korea

NOT YET RECRUITING

Pusan national Univ. Hosp.

Pusan, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

NOT YET RECRUITING

Seoul Asan Medical center

Seoul, South Korea

NOT YET RECRUITING

Severance hosp.

Seoul, South Korea

NOT YET RECRUITING

Ajou Univ Hosp.

Suwon, South Korea

NOT YET RECRUITING

Related Publications (2)

• 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.

  PMID: 26938947 BACKGROUND

• 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.

  PMID: 24714356 BACKGROUND

Related Links

• Web address

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus; Lymphoma; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Hyeon Seok Eom, MD

  National Cancer Center

  PRINCIPAL INVESTIGATOR

• Won Seog Kim, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Ho Jin Shin, MD

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

• Min-hee Ryu, MD

  Asan Medical Cente

  PRINCIPAL INVESTIGATOR

• Won Sik Lee, MD

  Inje University

  PRINCIPAL INVESTIGATOR

• Minsuk Kwon, MD

  Ajou Univ. Hosp.

  PRINCIPAL INVESTIGATOR

• Hyo song Kim, MD

  Severance Hosp

  PRINCIPAL INVESTIGATOR

• Jeeyun Lee, MD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sehee Hwang

CONTACT

+82-2-2071-3310; hsh0820@eutilex.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: December 28, 2018
• Study Start: December 14, 2018
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2024
• Last Updated: July 11, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (8)