Trials / Recruiting
RecruitingNCT04745403
Redirected HBV-Specific T Cells in Patients With HBV-related HCC (SAFE-T-HBV)
Safety and Tolerability Study of Redirected HBV-Specific T Cells in Patients With Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (SAFE-T-HBV)
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- Sponsor
- Lion TCR Pte. Ltd. · Industry
- Sex
- All
- Age
- 21 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This is a single center, single arm and open-label study to determine the safety of mRNA modified HBV-TCR redirected T-cells and to analyze the changes in tumor microenvironment caused by these HBV-TCR redirected T-cells in subjects with HBV-related HCC who are not amenable to/failed conventional treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | mRNA HBV/TCR T-cells | Study Infusion The first dose of mRNA HBV-TCR T-cells at dose 1x10e5/kg BW will be infused on Day 0, and subsequently incremental doses on Day 14 and 28, up to the dose of 5-10x10e6/kg BW. |
Timeline
- Start date
- 2022-05-20
- Primary completion
- 2026-07-01
- Completion
- 2028-07-01
- First posted
- 2021-02-09
- Last updated
- 2023-11-18
Locations
1 site across 1 country: Singapore
Source: ClinicalTrials.gov record NCT04745403. Inclusion in this directory is not an endorsement.