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A Research for an immunotherapy combined with chemotherapy for patients with advanced solid tumors.

Research Project

Project/Area Number 24790708
Research Category

Grant-in-Aid for Young Scientists (B)

Allocation TypeMulti-year Fund
Research Field Gastroenterology
Research InstitutionKyushu University

Principal Investigator

HIJIKATA Yasuki  九州大学, 大学病院, 助教 (80460856)

Project Period (FY) 2012-04-01 – 2014-03-31
Project Status Completed (Fiscal Year 2013)
Budget Amount *help
¥4,160,000 (Direct Cost: ¥3,200,000、Indirect Cost: ¥960,000)
Fiscal Year 2013: ¥780,000 (Direct Cost: ¥600,000、Indirect Cost: ¥180,000)
Fiscal Year 2012: ¥3,380,000 (Direct Cost: ¥2,600,000、Indirect Cost: ¥780,000)
Keywords腫瘍免疫学 / 細胞傷害性T細胞 / RNF43 / 免疫寛容 / 臨床試験 / 樹状細胞 / 癌 / 腫瘍免疫 / 活性化リンパ球 / 免疫療法 / 制御性T細胞 / 抗腫瘍免疫
Research Abstract

Ten patients with advanced solid tumors were completed with the clinical trial. None of the patients suffered from severe adverse events. Clinical responses at 4 and 7 weeks after the treatment respectively showed that 9 and 5 patients were in stable disease (SD), and 1 and 4 patients were in progress disease (PD). The frequency of circulating regulatory T cells (Treg) significantly decreased after cyclophosphamide (CPM), and the higher decreasing rate of Treg was related with good clinical response. The positive response rate of RNF43-specific circulating T cells significantly increased in SD cases. Higher levels of serum IL-6 and IL-10 prior to the treatment were observed in PD cases. In conclusion, the combination of immunotherapy and CPM was tolerable, and may induce tumor specific immune responses accompanied by the reduction of Tregs and be efficient against advanced solid tumors. Both of IL-6 and IL-10 are considered to be good biomarkers to predict clinical response in advance.

Report

(3 results)
  • 2013 Annual Research Report   Final Research Report ( PDF )
  • 2012 Research-status Report
  • Research Products

    (26 results)

All 2014 2013 2012 2011 Other

All Journal Article (5 results) (of which Peer Reviewed: 4 results) Presentation (17 results) Remarks (4 results)

  • [Journal Article] TLR7 Ligand Augments GM-CSF-Initiated Antitumor Immunity through Activation of Plasmacytoid Dendritic Cells2014

    • Author(s)
      Narusawa M, Inoue H,Matsumura Y,Takahashi A, Inoue T, Watnabe A, Miyamoto S,Miura Y, Hijikata Y, Tanaka Y, Inoue M, Takayama K, Okazaki T, Hasegawa M, Nakanishi Y, Tani K
    • Journal Title

      Cancer Immunol Res

      Volume: 2(6) Issue: 6 Pages: 1-13

    • DOI

      10.1158/2326-6066.cir-13-0143

    • Related Report
      2013 Final Research Report
    • Peer Reviewed
  • [Journal Article] Development of novel immune therapies for solid tumors: phase I clinical trials in a single institute2012

    • Author(s)
      Hijikata Y, Murahashi -Iga M, Okazaki T, Tanaka Y, Odaira K, Okano S, Hisano T, Takahashi A, Marumoto T, Inoue H, Tani K
    • Journal Title

      Rinsho Ketsueki

      Volume: 53 Issue: 5 Pages: 487-492

    • DOI

      10.11406/rinketsu.53.487

    • NAID

      130004501683

    • ISSN
      0485-1439, 1882-0824
    • Related Report
      2013 Final Research Report
    • Peer Reviewed
  • [Journal Article] Absence of LTB4/BLT1 axis facilitates generation of mouse GM-CSF-induced long-lasting antitumor immunologic memory by enhancing innate and adaptive immune systems.2012

    • Author(s)
      Yokota,Y.
    • Journal Title

      Blood.

      Volume: 120 Issue: 17 Pages: 3444-3454

    • DOI

      10.1182/blood-2011-10-383240

    • Related Report
      2013 Final Research Report
    • Peer Reviewed
  • [Journal Article] 固形腫瘍に対する新規免疫療法の開発-当科における第1相臨床試験の現状-2012

    • Author(s)
      土方 康基 村橋 睦了 岡崎 利彦 谷 憲三朗
    • Journal Title

      臨床血液

      Volume: 53 Pages: 487-492

    • Related Report
      2012 Research-status Report
    • Peer Reviewed
  • [Journal Article] 樹状細胞療法の現状2011

    • Author(s)
      宮本将平 土方康基 岡崎利彦 谷憲三朗
    • Journal Title

      臨床と研究

      Volume: 第88巻4号

    • Related Report
      2013 Final Research Report
  • [Presentation] 進行固形腫瘍患者に対する少量シクロフォスファミド併用RNF43ペプチド特異的細胞療法第I相臨床試験2014

    • Author(s)
      土方康基
    • Organizer
      第12回に本臨床主要学会学術集会
    • Place of Presentation
      福岡市
    • Year and Date
      2014-07-17
    • Related Report
      2013 Final Research Report
  • [Presentation] A Phase I Clinical trial of RNF43 Peptide-specific Immune Cell Therapy Combined with Low Dose Cyclophosphamide for Patients with Advanced Solid Tumors2014

    • Author(s)
      Hijikata Yasuki
    • Organizer
      The 5th JSH International Symposium
    • Place of Presentation
      Hamamatsu city
    • Year and Date
      2014-05-24
    • Related Report
      2013 Final Research Report
  • [Presentation] A Phase I clinical trial of RNF43 peptide-specific immune cell therapy combined with low dose cyclophosphamide for patients with advanced solid tumors2014

    • Author(s)
      Hijikata Yasuki
    • Organizer
      American Association for Cancer Research Annual Meeting
    • Place of Presentation
      米国 San Diego
    • Year and Date
      2014-04-08
    • Related Report
      2013 Final Research Report
  • [Presentation] 当科における難治性悪性腫瘍に対する免疫療法臨床試験の現状2014

    • Author(s)
      土方康基, 他
    • Organizer
      第11回日本免疫治療学研究会学術集会
    • Place of Presentation
      東京都文京区
    • Year and Date
      2014-02-22
    • Related Report
      2013 Annual Research Report 2013 Final Research Report
  • [Presentation] A phase I clinical trial of RNF43 peptide-specific immune cell therapy combined with low dose cyclophosphamide for patients with advanced solid tumors.2014

    • Author(s)
      Hijikata Yasuki
    • Organizer
      American Association for Cancer Research Annual Meeting
    • Place of Presentation
      米国San Diego
    • Related Report
      2013 Annual Research Report
  • [Presentation] A Phase I Clinical Trial of RNF43 Peptide-specific Immune Cell Therapy Combined with Low Dose Cyclophosphamide for Patients with Advanced Solid Tumors2014

    • Author(s)
      Hijikata Yasuki
    • Organizer
      The 5th JSH International Symposium 2014
    • Place of Presentation
      浜松市
    • Related Report
      2013 Annual Research Report
  • [Presentation] 進行固形腫瘍患者に対する少量シクロフォスファミド併用RNF43ペプチド特異的細胞療法第I相臨床試験2014

    • Author(s)
      土方 康基
    • Organizer
      第12回日本臨床腫瘍学会学術集会
    • Place of Presentation
      福岡市
    • Related Report
      2013 Annual Research Report
  • [Presentation] 進行固形腫瘍患者に対する新規免疫細胞療法第I相臨床研究2013

    • Author(s)
      土方康基, 他
    • Organizer
      第51回日本癌治療学会学術集会
    • Place of Presentation
      京都市
    • Year and Date
      2013-10-26
    • Related Report
      2013 Final Research Report
  • [Presentation] 進行固形腫瘍に対する化学療法併用新規免疫細胞療法第I相臨床研究2013

    • Author(s)
      土方康基, 他
    • Organizer
      第72回日本癌学会
    • Place of Presentation
      横浜市
    • Year and Date
      2013-10-05
    • Related Report
      2013 Final Research Report
  • [Presentation] RNF43 ペプチドパルス樹状細胞療法ならびにRNF43ペプチドパルス特異的活性化リンパ球を用いた進行固形腫瘍患者に対する強化養子免疫療法第I相臨床研究2013

    • Author(s)
      土方康基, 他
    • Organizer
      第5回造血器腫瘍免疫療法研究会
    • Place of Presentation
      名古屋市
    • Year and Date
      2013-08-24
    • Related Report
      2013 Final Research Report
  • [Presentation] RNF43ペプチドパルス樹状細胞ならびにRNF43ペプチド特異的活性化リンパ球を用いた進行固形腫瘍患者に対する強化養子免疫療法第1相臨床試験2013

    • Author(s)
      土方 康基
    • Organizer
      第5回造血器腫瘍免疫療法研究会
    • Place of Presentation
      名古屋市
    • Related Report
      2013 Annual Research Report
  • [Presentation] 進行固形腫瘍患者に対する化学療法併用新規免疫細胞療法第1相臨床研究2013

    • Author(s)
      土方 康基
    • Organizer
      第72回日本癌学会学術総会
    • Place of Presentation
      横浜市
    • Related Report
      2013 Annual Research Report
  • [Presentation] 進行固形腫瘍患者に対する新規免疫細胞療法第1相臨床研究2013

    • Author(s)
      土方 康基
    • Organizer
      第51回日本癌治療学会学術集会
    • Place of Presentation
      京都市
    • Related Report
      2013 Annual Research Report
  • [Presentation] 進行固形腫瘍患者に対する化学療法併用新規免疫細胞療法臨床研究2012

    • Author(s)
      土方康基, 他
    • Organizer
      第50回日本癌治療学会学術集会
    • Place of Presentation
      横浜市
    • Year and Date
      2012-10-26
    • Related Report
      2013 Final Research Report
  • [Presentation] RNF43ペプチドパルス樹状細胞療法ならびにRNF43ペプチドパルス特異的活性化リンパ球を用いた進行固形腫瘍患者に対する強化養子免疫療法第一相臨床試験2012

    • Author(s)
      土方康基, 他
    • Organizer
      第4回造血器腫瘍免疫療法研究会
    • Place of Presentation
      金沢市
    • Year and Date
      2012-08-01
    • Related Report
      2013 Final Research Report
  • [Presentation] RNF43ペプチドパルス樹状細胞ならびにRNF43ペプチド特異的活性化リンパ球を用いた進行固形腫瘍患者に対する強化養子免疫療法第一相臨床試験2012

    • Author(s)
      土方 康基
    • Organizer
      第4回造血器腫瘍免疫療法研究会
    • Place of Presentation
      金沢
    • Related Report
      2012 Research-status Report
  • [Presentation] 進行固形腫瘍患者に対する化学療法併用新規免疫細胞療法臨床研究2012

    • Author(s)
      土方 康基
    • Organizer
      第50回日本癌治療学会学術集会
    • Place of Presentation
      横浜
    • Related Report
      2012 Research-status Report
  • [Remarks]

    • URL

      http://www.umin.ac.jp/ctr/index-j.htm

    • Related Report
      2013 Final Research Report
  • [Remarks] 九州大学病院 先端分子・細胞治療科

    • Related Report
      2013 Annual Research Report
  • [Remarks] UMIN臨床試験登録システム

    • Related Report
      2013 Annual Research Report
  • [Remarks] RNF43ペプチドパルス樹状細胞/特異的活性化リンパ球を用いた強化養子免疫療法第I相臨床試験

    • URL

      https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000004749&language=J

    • Related Report
      2012 Research-status Report

URL: 

Published: 2013-05-31   Modified: 2019-07-29  

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