Drugs / TCR-T
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT02719782 | Jul 2015 → May 2019 | hepatocellular carcinoma | Lion TCR Pte. Ltd. | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2024-11-14 | Lion TCR Pte. Ltd. | Regulatory Lion TCR Secures China NMPA IND Approval for GZL-016, an Innovative mRNA-based TCR-T Cell Therapy for Hepatocellular Carcinoma liontcr.com ↗
On November 14, 2024, Lion TCR, a clinical-stage T-cell immunotherapy company, announced that it has received clearance from the China National Medical Products Administration (NMPA) for its Investigational New Drug (IND) application for GZL-016. |
| 2022-11-09 | Lion TCR Pte. Ltd. | Results Lion TCR Announces Poster Presentation of Phase 1 Study for Lead Product LioCyx-M at AASLD The Liver Meeting 2022 liontcr.com ↗
The data conclusively demonstrated the differential liver function, viral and immune alterations in patient with and without clinical response, implicating the importance of secondary immune response activation via the cancer-immunity cycle for durable anti-tumor effects of LioCyx-M. |
| 2021-02-08 | Lion TCR Pte. Ltd. | Results Lion TCR Announces Data Presentation for its lead T-cell product, LioCyx-M at EASL Digital Liver Cancer Summit 2021 liontcr.com ↗
The median overall survival was 33.57 months with a follow-up period of 47.9 months and an objective response rate of 16.7%, as compared to a median OS of 10.7 months achieved by FDA-approved first-line drug sorafenib (Llovet et al, N Engl J Med, 2008). |
| 2020-12-09 | Lion TCR Pte. Ltd. | Results Lion TCR COO Dr Tina Wang’s sharing at Phar-East Asia's Pharma & Biotech Festival 2020 liontcr.com ↗
This presentation covered key clinical safety data of Lion TCR’s lead product, LioCyx-M, autologous HBV-specific TCR T cells, inpatients with advanced HCC (NCT03899415) and HCC relapse post liver transplantation (NCT02719782). |
| 2020-11-10 | Lion TCR Pte. Ltd. | Results Lion TCR presents two abstracts of Phase 1 clinical trial data for lead product LioCyx-M at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting liontcr.com ↗
Each of these abstracts highlights the good safety profile and efficacy of LioCyx-M and the promising use of HBV-specific TCR-T therapy in HBV-related HCC. |
| 2018-08-19 | Lion TCR Pte. Ltd. | Regulatory Singapore’s first clinical trial approval for T cell engineered (TCR) immunotherapy for treatment of Liver cancer liontcr.com ↗
Aug 19, 2018 – Lion TCR Pte. Ltd., a Singapore-based Biotech company receives approval from Health Sciences Authority (HSA), Singapore, for its Phase I/II multicentre clinical study of its product candidate (LioCyx™) for treatment of relapsed liver cancer post-liver transplantation. |
| 2017-08-16 | Lion TCR Pte. Ltd. | Regulatory US FDA grants Lion TCR two orphan drug designations of T cell therapy against Hepatocellular Carcinoma liontcr.com ↗
Aug. 16, 2017 — US FDA has granted two orphan drug designations (ODD) for T cell therapy products to Singapore-based biotech company, Lion TCR Pte Ltd, for the treatment of hepatocellular carcinoma (HCC). |
| 2017-08-07 | Lion TCR Pte. Ltd. | Results Breakthrough immunotherapy for Chronic Hepatitis B virus infection liontcr.com ↗
This study, a collaborative effort between Duke-NUS, various prestigious Singapore & German institutions and Lion TCR, provides a potential solution to control the HBV infection, potentially complete clearance of HBV virus and possibly leading to a cure for CHB. |
| 2017-01-25 | Lion TCR Pte. Ltd. | Results Immunotherapy of HCC metastases with autologous T cell receptor redirected T cells, targeting HBsAg in a liver transplant patient liontcr.com ↗
Gene-modified T cells survived, expanded and mediated a reduction in HBsAg levels without exacerbation of liver inflammation or other toxicity. |
| 2016-05-26 | Lion TCR Pte. Ltd. | Results Dr. Antonio Bertoletti presents Lion TCR T-cell therapy at the International Society for Cellular Therapy Conference 2016 liontcr.com ↗
He further presented our latest clinical results in treating liver transplant patients with chemotherapy-resistant HCC metastases. |
All press releases naming this drug 11 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | TCR-T | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02719782 ↗ |
| Modality | Cell therapy | “Autologous T cells transfected with mRNA encoding HBV antigen-specific TCR” NCT02719782 ↗ |