Actively Recruiting
Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma
Led by Lion TCR Pte. Ltd. · Updated on 2025-05-08
10
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
Sponsors
L
Lion TCR Pte. Ltd.
Lead Sponsor
B
Beijing GoBroad Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of hepatocellular carcinoma by histology, cytology, or clinical diagnosis
- HCC that cannot be treated with curative surgery or locoregional therapies, or that has progressed after such treatments
- Has failed at least one systemic therapy for HCC
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
- Positive for hepatitis B surface antigen (HBsAg)
- Child-Pugh liver function score between 5 and 7 (Class A)
- Life expectancy of at least 1 year
- HLA type of either HLA-A02:01 or HLA-A24:02
You will not qualify if you...
- Presence of brain metastasis
- Having a second primary cancer that can be detected clinically at enrollment, except for in situ cervical carcinoma, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, Stage I uterine cancer, or superficial bladder tumors
- Receiving any other anti-cancer treatment including chemotherapy, tyrosine kinase inhibitors, or immunotherapy during the study
- Use of any investigational drug or device within 28 days before starting study treatment
- Hepatitis B virus DNA levels equal to or above 200 IU/ml at screening
- Hepatitis B surface antigen levels equal to or above 10,000 IU/ml at screening
- Women who are pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Gaobo Boren Hospital
Beijing, China
Actively Recruiting
Research Team
W
Wang Zhe
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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