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First-in-Human Phase 1 Study of a B Cell- and Monocyte-Based Immunotherapeutic Vaccine Against HER2-Positive Advanced Gastric Cancer

Authors
 Minkyu Jung  ;  Jii Bum Lee  ;  Hyo Song Kim  ;  Woo Sun Kwon  ;  Hyun Ok Kim  ;  Sinyoung Kim  ;  Myunghwan Park  ;  Wuhyun Kim  ;  Ki-Young Choi  ;  Taegwon Oh  ;  Chang-Yuil Kang  ;  Hyun Cheol Chung  ;  Sun Young Rha 
Citation
 CANCER RESEARCH AND TREATMENT, Vol.56(1) : 208-218, 2024-01 
Journal Title
CANCER RESEARCH AND TREATMENT
ISSN
 1598-2998 
Issue Date
2024-01
MeSH
Antibodies, Monoclonal, Humanized ; Humans ; Immunotherapy ; Monocytes / pathology ; Stomach Neoplasms* / drug therapy ; Trastuzumab / therapeutic use ; Vaccines* / therapeutic use
Keywords
First in-human study ; HER2 ; Immunotherapeutic vaccine ; Stomach neopla는
Abstract
Purpose
BVAC-B is an autologous B cell- and monocyte-based immunotherapeutic vaccine that contains cells transfected with a recombinant human epidermal growth factor receptor 2 (HER2) gene and loaded with the natural killer T cell ligand alpha-galactosylceramide. Here, we report the first BVAC-B study in patients with HER2-positive advanced gastric cancer.

Materials and Methods
Patients with advanced gastric cancer refractory to standard treatment with HER2+ immunohistochemistry > 1 were eligible for treatment. Patients were administered low (2.5 × 107 cells/dose), medium (5.0 × 107 cells/dose), or high dose (1.0 X 108 cells/dose) of BVAC-B intravenously four times every four weeks. Primary endpoints included safety and maximum tolerated BVAC-B dose. Secondary endpoints included preliminary clinical efficacy and BVAC-B-induced immune responses.

Results
Eight patients were treated with BVAC-B at low (n=1), medium (n=1), and high doses (n=6). No dose-limiting toxicity was observed, while treatment-related adverse events (TRAEs) were observed in patients treated with medium and high doses. The most common TRAEs were grade 1 (n=2) and grade 2 (n=2) fever. Out of the six patients treated with high dose BVAC-B, three had stable disease with no response. Interferon gamma, tumor necrosis factor-α, and interleukin-6 increased after BVAC-B treatment in all patients with medium and high dose, and HER2 specific antibody was detected in some patients.

Conclusion
BVAC-B monotherapy had a safe toxicity profile with limited clinical activity; however, it activated immune cells in heavily pretreated patients with HER2-positive gastric cancer. Earlier treatment with BVAC-B and combination therapy is warranted for evaluation of clinical efficacy.
Files in This Item:
T202400928.pdf Download
DOI
10.4143/crt.2022.1328
Appears in Collections:
1. College of Medicine (의과대학) > Research Institute (부설연구소) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Laboratory Medicine (진단검사의학교실) > 1. Journal Papers
Yonsei Authors
Kwon, Woo Sun(권우선) ORCID logo https://orcid.org/0000-0003-0268-5624
Kim, Sin Young(김신영) ORCID logo https://orcid.org/0000-0002-2609-8945
Kim, Hyun Ok(김현옥) ORCID logo https://orcid.org/0000-0002-4964-1963
Kim, Hyo Song(김효송) ORCID logo https://orcid.org/0000-0002-0625-9828
Rha, Sun Young(라선영) ORCID logo https://orcid.org/0000-0002-2512-4531
Lee, Jii Bum(이기쁨) ORCID logo https://orcid.org/0000-0001-5608-3157
Jung, Min Kyu(정민규) ORCID logo https://orcid.org/0000-0001-8281-3387
Chung, Hyun Cheol(정현철) ORCID logo https://orcid.org/0000-0002-0920-9471
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/198583
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