This is an open-label and multi-center Phase 2 study to evaluate the safety and efficacy of autologous T-cells transfected with mRNA encoding Hepatitis-B virus (HBV)-antigen-specific T cell receptor (TCR) (LioCyx-M) as monotherapy or as combination with lenvatinib for the treatment of advanced HBV-related hepatocellular carcinoma (HCC).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
HBV antigen specific TCR redirected T cells
12 mg once daily for patients ≥60 kg, 8 mg for patients \<60kg by oral
Assessments of adverse events/serious adverse events
To evaluate the safety of LioCyx-M as a monotherapy and in combination with lenvatinib
Time frame: Up to 4 years from study treatment initiation
Objective response rate (ORR)
To evaluate the anti-tumor efficacy of LioCyx-M as a monotherapy and in combination with lenvatinib
Time frame: Up to 4 years from study treatment initiation
Progression free survival (PFS)
To evaluate the anti-tumor efficacy of LioCyx-M as a monotherapy and in combination with lenvatinib
Time frame: Up to 4 years from study treatment initiation
Time to radiographic progression (TTRP)
To evaluate the anti-tumor efficacy of LioCyx-M as a monotherapy and in combination with lenvatinib
Time frame: Up to 4 years from study treatment initiation
Duration of response (DoR)
To evaluate the anti-tumor efficacy of LioCyx-M as a monotherapy and in combination with lenvatinib
Time frame: Up to 4 years from study treatment initiation
Overall survival (OS)
To evaluate the anti-tumor efficacy of LioCyx-M as a monotherapy and in combination with lenvatinib
Time frame: Up to 4 years from study treatment initiation
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