Current status of major projects

Information on each clinical trial

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.
  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
  ;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
  ;NCT02869217

TBI-2001, CD19·JAK/STAT·CAR

• Pre-clinical Studies in Progress

Information on closed clinical trial

TBI-1401 (HF10), 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.
  ;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.
  ;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.
  ;JapicCTI-173671, NCT03252808

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.
  ;JapicCTI-173565, NCT03155191

For inquiry on any clinical trial

Please send an email to the following address

takara-clinical@takara-bio.co.jp