Safety and Efficacy of Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
This is a single center and open-label study to determine the safety and efficacy of mRNA HBV-TCR redirected T-cells in HBV-related HCC who are not amenable to/failed conventional treatment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• HCC diagnosis confirmed by histology/ cytology or clinically
• HCC that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies
• Has failed at least one line of systemic therapy for HCC
• ECOG performance status ≤1
• Serum HBsAg positivity
• Child-Pugh A (5 - 7 points)
• Life expectancy of at least 1 year
• HLA profile: HLA-A\*02:01 or HLA-A\*24:02
Locations
Other Locations
China
Gaobo Boren Hospital
RECRUITING
Beijing
Contact Information
Primary
Wang Zhe
zhe.wang@liontcr.com
+86 15902091916
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2028-12-01
Participants
Target number of participants: 10
Treatments
Experimental: LioCyx-M
LioCyx-M, HBV antigen-specific TCR-redirected T cells, will be administered every week at a dose of 5-10 x 10\^6 cells/kg body weight (BW).
Related Therapeutic Areas
Sponsors
Collaborators: Beijing GoBroad Hospital
Leads: Lion TCR Pte. Ltd.