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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Autologous B cell and monocyte presenting HER2/neu antigen
Severance Hospital
Seoul, Seodaemun-gu, South Korea
Evaluate Maximum tolerated dose(MTD) for phase 2 trial
Find Serious adverse drug reaction(Grade 3)
Time frame: End of Dose-escalation stage(7 month from study start, Estimated)
Incidence of Serious Adverse Events assessed with CTCAE v4.03
Evaluate safety and tolerability
Time frame: 14th week from first injection
Serum cytokine
Measure Interferon(IFN)-r, Interleukin(IL)-4
Time frame: Screening visit, Visit 2 (0 week) , visit 4 (4 week) ,visit 5 (6 week), visit 6 (8 week), visit 8(12 week), Termination visit(16 week)
HER2/neu specific antibody
Measure HER2/neu specific antibody concentration
Time frame: Screening visit, every 2 weeks after 1st injection(till 16th week)
NKT/NK cell assay
Measure NKT/NK cell activity
Time frame: Screening visit, every 24hr after injection(up to 12th week)
CD4/CD8 assay
Measure CD4/CD8 T cell activity
Time frame: Screening visit, every 2 weeks after 1st injection(up to 16th week)
Lymphocyte subset
Measure change of lymphocyte subset
Time frame: Screening visit, visit 4 (4 week), visit 6 (8 week), visit 8 (12 week), termination visit (16 week)
Change of tumor burden
Measure change of tumor burden by CT/MRI to determine pre-effecacy
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Time frame: Screening visit, Termination visit(16th week)