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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BVAC-B | Experimental | BVAC-B IV injection at 0, 4, 8, 12nd weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BVAC-B | Biological | Autologous B cell and monocyte presenting HER2/neu antigen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate Maximum tolerated dose(MTD) for phase 2 trial | Find Serious adverse drug reaction(Grade 3) | 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 | 14th week from first injection |
| Measure | Description | Time Frame |
|---|---|---|
| Serum cytokine | Measure Interferon(IFN)-r, Interleukin(IL)-4 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | Seodaemun-gu | 03722 | South Korea |
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Accelerated titration
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Measure HER2/neu specific antibody concentration
| Screening visit, every 2 weeks after 1st injection(till 16th week) |
| NKT/NK cell assay | Measure NKT/NK cell activity | Screening visit, every 24hr after injection(up to 12th week) |
| CD4/CD8 assay | Measure CD4/CD8 T cell activity | Screening visit, every 2 weeks after 1st injection(up to 16th week) |
| Lymphocyte subset | Measure change of lymphocyte subset | 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 | Screening visit, Termination visit(16th week) |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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