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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 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2022-07-11

No results posted yet for this study

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

Interventions

BIOLOGICAL

EBViNT Cell

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

Sponsors & Collaborators

  • Eutilex

    lead INDUSTRY

Principal Investigators

  • Hyeon Seok Eom, MD · National Cancer Center

  • Won Seog Kim, MD · Samsung Medical Center

  • Ho Jin Shin, MD · Pusan National University Hospital

  • Min-hee Ryu, MD · Asan Medical Cente

  • Won Sik Lee, MD · Inje University

  • Minsuk Kwon, MD · Ajou Univ. Hosp.

  • Hyo song Kim, MD · Severance Hosp

  • Jeeyun Lee, MD · Samsung Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-14
Primary Completion
2022-09-30
Completion
2024-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03789617 on ClinicalTrials.gov