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Hepatocellular CarcinomaPhase 2NCT05195294

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

A Phase 2 study testing LioCyx-M and Lenvatinib in people with Hepatocellular Carcinoma and Liver Cancer, Adult, run by Lion TCR Pte. Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
LioCyx-M and Lenvatinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
No sites listed yet
Study dates
Mar 2025to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Regina Wong contact

+65 68130738

regina.wong@liontcr.com

About this study

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

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).

Being tested
LioCyx-M, Lenvatinib
Keywords
TCR T cells, Hepatocellular Carcinoma, HBV, Hepatitis B virus
Medical subject headings
Carcinoma, Hepatocellular, Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LioCyx-MBiological

    HBV antigen specific TCR redirected T cells

  • LenvatinibDrug

    12 mg once daily for patients ≥60 kg, 8 mg for patients <60kg by oral

Study groups in NCT05195294
Study groupRoleWhat they receive
LioCyx-M monotherapyExperimentalPatients will receive up to 8 biweekly infusions of HBV antigen specific TCR redirected T cells (LioCyx-M).
Receives: Biological: LioCyx-M
LioCyx-M + lenvatinib combinational therapyExperimentalPatients will receive up to 8 biweekly infusions of HBV antigen specific TCR redirected T cells (LioCyx-M) with daily intake of lenvatinib.
Receives: Biological: LioCyx-M; Drug: Lenvatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assessments of adverse events/serious adverse events

    To evaluate the safety of LioCyx-M as a monotherapy and in combination with lenvatinib

    Measured: Up to 4 years from study treatment initiation

  2. Objective response rate (ORR)

    To evaluate the anti-tumor efficacy of LioCyx-M as a monotherapy and in combination with lenvatinib

    Measured: Up to 4 years from study treatment initiation

Secondary outcomes (4)

  1. Progression free survival (PFS)

    To evaluate the anti-tumor efficacy of LioCyx-M as a monotherapy and in combination with lenvatinib

    Measured: Up to 4 years from study treatment initiation

  2. Time to radiographic progression (TTRP)

    To evaluate the anti-tumor efficacy of LioCyx-M as a monotherapy and in combination with lenvatinib

    Measured: Up to 4 years from study treatment initiation

  3. Duration of response (DoR)

    To evaluate the anti-tumor efficacy of LioCyx-M as a monotherapy and in combination with lenvatinib

    Measured: Up to 4 years from study treatment initiation

  4. Overall survival (OS)

    To evaluate the anti-tumor efficacy of LioCyx-M as a monotherapy and in combination with lenvatinib

    Measured: Up to 4 years from study treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2022
  2. Study startMar 2025 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
55 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05195294
Sponsor's protocol ID
LTCR-HCC-3-4
Status last verified
Jan 2025
First submitted
3 Jun 2021
Last updated
10 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LioCyx-M and Lenvatinib in people with Hepatocellular Carcinoma and Liver Cancer, Adult, run by Lion TCR Pte. Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Regina Wong (+65 68130738, regina.wong@liontcr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessments of adverse events/serious adverse events (time frame: Up to 4 years from study treatment initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05195294.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.

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