Study of HBV-TCR T Cells (LioCyx-M) as Monotherapy or as Combination With Lenvatinib for HBV-rela… (NCT05195294) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study of HBV-TCR T Cells (LioCyx-M) as Monotherapy or as Combination With Lenvatinib for HBV-related HCC
55 participantsStarted 2025-03
Plain-language summary
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).
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
✓. Advanced HCC with diagnosis confirmed by histology/ cytology or clinically by AASLD criteria in cirrhotic patients.
✓. Disease that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies
✓. Patients who failed first-line systemic therapy for HCC
✓. Serum HBsAg positivity
✓. Non-cirrhotic or compensated cirrhosis Child-Pugh A (5 - 6 points)
✓. HLA class 1 profile matching HLA-class I restriction element of the available T cell receptor
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 tumours.
✕. Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples
✕. History of severe allergic anaphylactic reactions to T cell therapy products and/or lenvatinib
✕
What they're measuring
1
Assessments of adverse events/serious adverse events
Timeframe: Up to 4 years from study treatment initiation
2
Objective response rate (ORR)
Timeframe: Up to 4 years from study treatment initiation
. Local or loco-regional therapy of intrahepatic tumour lesions (e.g. surgery, radiation therapy, hepatic arterial embolization, chemoembolization, radiofrequency ablation, percutaneous ethanol injection, or cryoablation) must have been completed ≥4 weeks before the first infusion of LioCyx-M.
✕. Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, tyrosine kinase inhibitor therapy, and immunotherapy.
✕. Treatment with anticancer therapy, including investigational therapy, within 2 weeks prior to first infusion. For prior therapies with a half-life longer than 3 days, discontinuation of the therapy must have occurred at least 28 days prior to leukapheresis.
✕. Treatment with other investigational therapy within 28 days prior to initiation of study treatment. Patients participating in surveys or observational studies are eligible to participate in this study.