Menu
Not yet recruiting NCT05195294

Study of HBV-TCR T Cells (LioCyx-M) as Monotherapy or as Combination With Lenvatinib for HBV-related HCC

Phase II Interventional Hepatocellular Carcinoma Liver Cancer, Adult Liver Cell 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, Lenvatinib.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma, Liver Cancer, Adult, Liver Cell Carcinoma. Basic parameters: 18 years — 75 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
Center list to be confirmed — check the primary protocol.
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

A Multi-center, Phase 2 Study for Autologous T Cells Transfected With mRNA Encoding HBV Antigen-specific TCR (LioCyx-M) as Monotherapy or as Combination With Lenvatinib for Advanced HBV-related Hepatocellular Carcinoma

Overview

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).

Interventions

  • Biological LioCyx-M
    HBV antigen specific TCR redirected T cells
  • Drug Lenvatinib
    12 mg once daily for patients ≥60 kg, 8 mg for patients \<60kg by oral

Primary outcome measures

  • Assessments of adverse events/serious adverse events [Time frame: Up to 4 years from study treatment initiation]
  • Objective response rate (ORR) [Time frame: Up to 4 years from study treatment initiation]
Secondary outcome measures (4)
  • Progression free survival (PFS) [Time frame: Up to 4 years from study treatment initiation]
  • Time to radiographic progression (TTRP) [Time frame: Up to 4 years from study treatment initiation]
  • Duration of response (DoR) [Time frame: Up to 4 years from study treatment initiation]
  • Overall survival (OS) [Time frame: Up to 4 years from study treatment initiation]

Eligibility criteria

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
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05195294 · LTCR-HCC-3-4

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗