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-1301, NY-ESO-1・siTCR

  • 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.
    ;jRCT1080223459, 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
    ;jRCT2080222844, 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
    ;NCT02869217

TBI-2001, CD19・JAK/STAT・CAR

  • Phase I/Ib Study of TBI-2001 for Patients With Relapsed or Refractory CD19+ B-cell Lymphoma, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL) (Investigator-initiated clinical trial)
    Investigational Site: Princess Margaret Cancer Centre, Canada
    ; NCT05963217

Information on closed clinical trial

TBI-1401, Oncolytic virus C-REV

  • 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.
    ;jRCT1080223536, 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.
    ;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
    ;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.
    ;jRCT1080223615, NCT03252808

TBI-1501, CD19・CAR

  • 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.
    ;jRCT1080223510, NCT03155191

For inquiry on any clinical trial

Please send an email to the following address
takara-clinical@takara-bio.co.jp