Clinical trials

Current status of major projects
    Note : We have also been advancing other investigator-initiated clinical trials and clinical research in addition to the above projects.
Information on each clinical trial
TBI-1401 (HF10)
  • A Phase II Study of Combination Treatment With TBI-1401(HF10), a Replication-competent HSV-1 Oncolytic Virus, and Ipilimumab in Japanese Patients With Stage IIIB, IIIC, or IV Unresectable or Metastatic Malignant Melanoma
    Investigational Site: National Cancer Center Hospital et al.
    Started in May, 2017 (JapicCTI-173591, NCT03153085)
  • A Phase II Study of Combination Treatment with HF10, a Replication-competent HSV-1 Oncolytic Virus, and Ipilimumab in Patients with Stage IIIB, Stage IIIC, or Stage IV Unresectable or Metastatic Melanoma
    Investigational Site: Huntsman Cancer Institute, University of Utah et al.
    Completed in March, 2017 (NCT02272855)
  • Phase II Neoadjuvant trial of Nivolumab in Combination with HF10 Oncolytic Viral Therapy in Resectable Stage IIIB, IIIC, IVM1a Melanoma (Neo-NivoHF10) (Investigator-initiated clinical trial)
    Investigational Site: Huntsman Cancer Institute, University of Utah
    Started in December, 2017 (NCT03259425)
  • Phase I Study of Combination With TBI-1401(HF10), a Replication-competent HSV-1 Oncolytic Virus, and Chemotherapy in Japanese Patients With Stage III or IV Unresectable Pancreatic Cancer
    Investigational Site: Kanagawa Cancer Center et al.
    Started in August, 2017 (JapicCTI-173671, NCT03252808)
TBI-1301
  • Multi-center Phase I/II Study of NY-ESO-1 T Cell Receptor Gene Transferred T Lymphocytes in Patients With Synovial Sarcoma
    Investigational Site: National Hospital Organization Osaka National Hospital, Mie University Hospital, Sapporo Medical University Hospital et al.
    Started in January 2017 (JapicCTI- 173514, NCT03250325)
  • Multi-center, Investigator Initiated Phase 1 Study of NY-ESO-1 Specific TCR Gene Transferred T Lymphocytes With Solid Tumors
    Investigational Site: Mie University Hospital, Aichi Medical University Hospital, Keio University Hospital, National Cancer Center Hospital East, National Cancer Center Hospital, and Nagoya Medical Center
    Completed in September, 2018 (JapicCTI- 152896, NCT02366546)
  • Phase Ib Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients with Solid Tumors (Investigator-initiated clinical trial)
    Investigational Site: Princess Margaret Cancer Centre, Canada
    Started in August, 2016 (NCT02869217)
TBI-1501
  • A Multicenter Phase I/II Study for Relapsed or Refractory CD19+ B-acute Lymphoblastic Leukemia
    Investigational Site: Jichi Medical University Hospital, The Institute of Medical Science, the University of Tokyo, Mie University Hospital et al.
    Started in January, 2017 (JapicCTI-173565, NCT03155191)
For inquiry on any clinical trial

Please send an email to the following address

takara-clinical@takara-bio.co.jp

return to top