Status:
NOT_YET_RECRUITING
Study of HBV-TCR T Cells (LioCyx-M) as Monotherapy or as Combination With Lenvatinib for HBV-related HCC
Lead Sponsor:
Lion TCR Pte. Ltd.
Conditions:
Hepatocellular Carcinoma
Liver Cancer, Adult
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 (...
Eligibility Criteria
Inclusion
- 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
- 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
- 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.
- Likelihood to require any immunosuppressive treatments during the period of the clinical trial (Localized steroid use should be allowed)
- Human immunodeficiency virus (HIV) positive or active infection requiring treatment (except for HBV)
- Significant cardiovascular disease (such as New York Heart Association (NYHA) Functional Classification Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident within 3 months prior to initiation of study treatment), unstable arrhythmia, or unstable angina
- Uncontrolled hypertension, defined as systolic blood pressure \>160 mmHg or diastolic pressure \>110 mmHg, despite optimal medical management
Key Trial Info
Start Date :
March 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT05195294
Start Date
March 1 2025
End Date
December 1 2028
Last Update
March 10 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.