Safety and Tolerability Evaluation Study of BVAC-B in Patients With HER2/Neu(Human Epithelial Growth Factor Receptor 2) Positive Gastric Cancer After Failure to Standard Care
NCT03425773 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8
Last updated 2020-02-20
Summary
BVAC-B is immunotherapeutic vaccine using B-Cell and Monocytes as antigen presenting cell. This study is Open-label, Accelerated titration, Multiple dosing study to evaluate the safety, tolerability, immune response and pre-efficacy of BVAC-B in patients with progressive or recurrent HER2/neu positive gastric cancer after failure to standard care. 9-27 patients will be enrolled.
Conditions
- Stomach Neoplasms
Interventions
- BIOLOGICAL
-
BVAC-B
Autologous B cell and monocyte presenting HER2/neu antigen
Sponsors & Collaborators
-
Cellid Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-02-26
- Primary Completion
- 2019-05-13
- Completion
- 2019-05-13
Countries
- South Korea
Study Locations
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