Recruiting NCT06961617
Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LioCyx-M, HBV antigen-specific TCR-redirected T cells.
- Who it may be relevant to
- Registry conditions: Hepatocellular Carcinoma. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Safety and Efficacy of Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma
Overview
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.
Interventions
- Drug LioCyx-M, HBV antigen-specific TCR-redirected T cells
Via intravenous (IV) infusion
Primary outcome measures
- Assessments of adverse events/serious adverse events [Time frame: Start of treatment until 28 days post last dose]
- Objective Response Rate (ORR) [Time frame: Up to 2 years]
Secondary outcome measures (3)
- Duration of Response (DoR) [Time frame: Up to 2 years]
- Progression Free Survival (PFS) [Time frame: Up to 2 years]
- Overall Survival (OS) [Time frame: Up to 2 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Brain metastasis
- Second primary malignancy that is clinically detectable at the time of consideration for study enrolment, except for in situ carcinoma of the cervix, non-melanoma skin carcinoma localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer and superficial bladder tumors
- Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, TKI therapy, and immunotherapy.
- Use of any investigational product (IP) or investigational medical device within 28 days of study drug administration
- Serum HBV DNA levels ≥ 200 IU/ml at screening
- Serum HBsAg levels ≥ 10,000 IU/ml at screening
- Women who are pregnant or breast-feeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Gaobo Boren Hospital — Beijing
Identifiers
NCT: NCT06961617 · LTCR-HCC-3-6