PMID- 37509288
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230731
IS  - 2072-6694 (Print)
IS  - 2072-6694 (Electronic)
IS  - 2072-6694 (Linking)
VI  - 15
IP  - 14
DP  - 2023 Jul 14
TI  - Clinical Trial on the Safety and Tolerability of Personalized Cancer Vaccines 
      Using Human Platelet Lysate-Induced Antigen-Presenting Cells.
LID - 10.3390/cancers15143627 [doi]
LID - 3627
AB  - Research and development of personalized cancer vaccines as precision medicine 
      are ongoing. We predicted human leukocyte antigen (HLA)-compatible cancer antigen 
      candidate peptides based on patient-specific cancer genomic profiles and 
      performed a Phase I clinical trial for the safety and tolerability of cancer 
      vaccines with human platelet lysate-induced antigen-presenting cells (HPL-APCs) 
      from peripheral monocytes. Among the five enrolled patients, two patients 
      completed six doses per course (2-3 x 10(7) cells per dose), and an interim 
      analysis was performed based on the immune response. An immune response was 
      detected by enzyme-linked immunosorbent spot (ELISpot) assays to 
      HLA-A*33:03-matched KRAS(WT), HLA-DRB1*09:01-compliant KRAS(WT or G12D), or 
      HLA-A*31:01-matched SMAD4(WT), and HLA-DRB1*04:01-matched SMAD4(G365D) peptides 
      in two completed cases, respectively. Moreover, SMAD4(WT)-specific CD8(+) 
      effector memory T cells were amplified. However, an attenuation of the acquired 
      immune response was observed 6 months after one course of cancer vaccination as 
      the disease progressed. This study confirmed the safety and tolerability of 
      HPL-APCs in advanced and recurrent cancers refractory to standard therapy and is 
      the first clinical report to demonstrate the immunoinducibility of personalized 
      cancer vaccines using HPL-APCs. Phase II clinical trials to determine immune 
      responses with optimized adjuvant drugs and continued administration are expected 
      to demonstrate efficacy.
FAU - Koya, Terutsugu
AU  - Koya T
AUID- ORCID: 0000-0003-0804-1045
AD  - Department of Regenerative Medicine, Kanazawa Medical University, Kahoku 
      920-0293, Ishikawa, Japan.
AD  - Center for Regenerative Medicine, Kanazawa Medical University Hospital, Kahoku 
      920-0293, Ishikawa, Japan.
FAU - Yoshida, Kenichi
AU  - Yoshida K
AD  - Center for Regenerative Medicine, Kanazawa Medical University Hospital, Kahoku 
      920-0293, Ishikawa, Japan.
FAU - Togi, Misa
AU  - Togi M
AUID- ORCID: 0000-0002-7424-4548
AD  - Department of Regenerative Medicine, Kanazawa Medical University, Kahoku 
      920-0293, Ishikawa, Japan.
AD  - Center for Regenerative Medicine, Kanazawa Medical University Hospital, Kahoku 
      920-0293, Ishikawa, Japan.
FAU - Niida, Yo
AU  - Niida Y
AUID- ORCID: 0000-0001-5641-7962
AD  - Division of Genomic Medicine, Department of Advanced Medicine, Medical Research 
      Institute, Kanazawa Medical University, Kahoku 920-0293, Ishikawa, Japan.
FAU - Togi, Sumihito
AU  - Togi S
AUID- ORCID: 0000-0002-3189-8111
AD  - Division of Genomic Medicine, Department of Advanced Medicine, Medical Research 
      Institute, Kanazawa Medical University, Kahoku 920-0293, Ishikawa, Japan.
FAU - Ura, Hiroki
AU  - Ura H
AUID- ORCID: 0000-0002-7600-3481
AD  - Division of Genomic Medicine, Department of Advanced Medicine, Medical Research 
      Institute, Kanazawa Medical University, Kahoku 920-0293, Ishikawa, Japan.
FAU - Mizuta, Shuichi
AU  - Mizuta S
AD  - Department of Hematology and Immunology, Kanazawa Medical University, Kahoku 
      920-0293, Ishikawa, Japan.
FAU - Kato, Tomohisa Jr
AU  - Kato T Jr
AD  - Division of Stem Cell Medicine, Department of Advanced Medicine, Medical Research 
      Institute, Kanazawa Medical University, Kahoku 920-0293, Ishikawa, Japan.
FAU - Yamada, Sohsuke
AU  - Yamada S
AUID- ORCID: 0000-0003-2662-0024
AD  - Department of Pathology and Laboratory Medicine, Kanazawa Medical University, 
      Kahoku 920-0293, Ishikawa, Japan.
FAU - Shibata, Takeo
AU  - Shibata T
AD  - Department of Obstetrics and Gynecology, Kanazawa Medical University, Kahoku 
      920-0293, Ishikawa, Japan.
FAU - Liu, Yi-Chang
AU  - Liu YC
AD  - Division of Hematology and Oncology, Department of Internal Medicine, Kaohsiung 
      Medical University Hospital, Kaohsiung 807, Taiwan.
AD  - Faculty of Medicine, College of Medicine, Kaohsiung Medical University, Kaohsiung 
      807, Taiwan.
FAU - Yuan, Shyng-Shiou
AU  - Yuan SS
AUID- ORCID: 0000-0002-4753-788X
AD  - Office of Research & Development, Kaohsiung Medical University, Kaohsiung 807, 
      Taiwan.
FAU - Wu, Deng-Chyang
AU  - Wu DC
AD  - Internal Medicine, School of Medicine, Kaohsiung Medical University, Kaohsiung 
      807, Taiwan.
FAU - Kobayashi, Hirohito
AU  - Kobayashi H
AD  - Division of Transfusion and Cell Therapy, Tokyo Women's Medical University, 
      Adachi Medical Center, Adachi 123-8558, Tokyo, Japan.
FAU - Utsugisawa, Taiju
AU  - Utsugisawa T
AD  - Department of Transfusion Medicine and Cell Processing, Tokyo Women's Medical 
      University, Shinjuku 162-8666, Tokyo, Japan.
FAU - Kanno, Hitoshi
AU  - Kanno H
AD  - Department of Transfusion Medicine and Cell Processing, Tokyo Women's Medical 
      University, Shinjuku 162-8666, Tokyo, Japan.
FAU - Shimodaira, Shigetaka
AU  - Shimodaira S
AUID- ORCID: 0000-0002-6612-6912
AD  - Department of Regenerative Medicine, Kanazawa Medical University, Kahoku 
      920-0293, Ishikawa, Japan.
AD  - Center for Regenerative Medicine, Kanazawa Medical University Hospital, Kahoku 
      920-0293, Ishikawa, Japan.
AD  - Division of Stem Cell Medicine, Department of Advanced Medicine, Medical Research 
      Institute, Kanazawa Medical University, Kahoku 920-0293, Ishikawa, Japan.
AD  - Department of Transfusion Medicine and Cell Processing, Tokyo Women's Medical 
      University, Shinjuku 162-8666, Tokyo, Japan.
LA  - eng
PT  - Journal Article
DEP - 20230714
PL  - Switzerland
TA  - Cancers (Basel)
JT  - Cancers
JID - 101526829
PMC - PMC10377585
OTO - NOTNLM
OT  - antigen-presenting cells
OT  - enzyme-linked immunosorbent assay
OT  - in silico prediction
OT  - memory T cells
OT  - personalized cancer vaccine
COIS- S.S., T.K. and M.T. are patent inventors for a method for manufacturing human 
      platelet lysate-inducible interferon (IFN)-DCs (PCT/JP/2021/040505). S.S., T.K. 
      and M.T. evaluated the DCO-K serum-free medium (Nissui Pharmaceutical Co., Ltd.) 
      for the HPL-APC culture. Kanazawa Medical University concludes a collaborative 
      investigation contract with Nissui Pharmaceutical Co., Ltd. The funders had no 
      role in the design of the study, in the collection, analyses, or interpretation 
      of data, in the writing of the manuscript, or in the decision to publish the 
      results.
EDAT- 2023/07/29 11:47
MHDA- 2023/07/29 11:48
PMCR- 2023/07/14
CRDT- 2023/07/29 01:11
PHST- 2023/05/27 00:00 [received]
PHST- 2023/06/27 00:00 [revised]
PHST- 2023/07/11 00:00 [accepted]
PHST- 2023/07/29 11:48 [medline]
PHST- 2023/07/29 11:47 [pubmed]
PHST- 2023/07/29 01:11 [entrez]
PHST- 2023/07/14 00:00 [pmc-release]
AID - cancers15143627 [pii]
AID - cancers-15-03627 [pii]
AID - 10.3390/cancers15143627 [doi]
PST - epublish
SO  - Cancers (Basel). 2023 Jul 14;15(14):3627. doi: 10.3390/cancers15143627.