Drugs / TBI-1301
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT02869217 | Sep 2016 → Nov 2026 expected | esophageal cancer, liver cancer, lung cancer, melanoma +3 | University Health Network, Toronto | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02366546 | Mar 2015 → Sep 2018 | cancer | Mie University | Unknown | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03250325 | Sep 2017 → Jan 2020 | synovial sarcoma | Takara Bio Inc. | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07174427 | Jan 2026 → Mar 2032 expected | synovial sarcoma | Takara Bio Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2020-06-24 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Clinical program for NY-ESO-1/siTCR gene therapy candidate receives designation in Japan as Orphan Regenerative MedicineTM otsuka.co.jp ↗
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Takara Bio Inc. (Takara Bio) announce that the clinical development program for gene therapy drug candidate NY-ESO-1・siTCR has received the Orphan Regenerative Medicine designation by the Ministry of Health, Labour and Welfare in Japan. |
| 2019-02-14 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Regulatory Designation Description Change of NY-ESO-1・siTCRTM gene therapy product under "SAKIGAKE Designation System" otsuka.co.jp ↗
has been approved for the description change of product under SAKIGAKE Designation System (hereinafter, "SAKIGAKE") by the Ministry of Health, Labour and Welfare as of February 14, 2019. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-06-24 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Clinical program for NY-ESO-1/siTCR gene therapy candidate receives designation in Japan as Orphan Regenerative MedicineTM otsuka.co.jp ↗ |
| 2019-02-14 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Designation Description Change of NY-ESO-1・siTCRTM gene therapy product under "SAKIGAKE Designation System" otsuka.co.jp ↗ |
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TBI-1301 | “Split dose of TBI-1301 is administered intravenously for 2 days following cyclophosphamide/fludarabine pre-treatment.” NCT07174427 ↗ |
| Action | Deplete | “TCR-T cells exhibited cytotoxic effects against NY-ESO-1-expressing tumor cells” PMID 35768164 ↗ Jun 2022 |
| Modality | Cell therapy | “the TCR-transduced T-cell product (TBI-1301)” PMID 35768164 ↗ Jun 2022 |
| Route | Intravenous | “given back to the subject through an intravenous infusion” NCT02869217 ↗ |