Hepatocellular CarcinomaPhase 1NCT06961617
Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma
A Phase 1 study testing LioCyx-M, HBV antigen-specific TCR-redirected T cells in people with Hepatocellular Carcinoma, run by Lion TCR Pte. Ltd. at 1 site in China.
Trial summary
This is a single center and open-label study to determine the safety and efficacy of mRNA HBV-TCR redirected T-cells in HBV-related HCC who are not amenable to/failed conventional treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- LioCyx-M, HBV antigen-specific TCR-redirected T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 1 Dec 2028
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HCC diagnosis confirmed by histology/ cytology or clinically
- HCC that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies
- Has failed at least one line of systemic therapy for HCC
- ECOG performance status ≤1
- Serum HBsAg positivity
- Child-Pugh A (5 - 7 points)
- Life expectancy of at least 1 year
- HLA profile: HLA-A*02:01 or HLA-A*24:02
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 tumors
- Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, TKI therapy, and immunotherapy.
- Use of any investigational product (IP) or investigational medical device within 28 days of study drug administration
- Serum HBV DNA levels ≥ 200 IU/ml at screening
- Serum HBsAg levels ≥ 10,000 IU/ml at screening
- Women who are pregnant or breast-feeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Gaobo Boren Hospital
Beijing
Wang Zhe, +86 15902091916, zhe.wang@liontcr.com
About this study
Official title: Safety and Efficacy of Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma
This is a single center and open-label study to determine the safety and efficacy of mRNA HBV-TCR redirected T-cells in HBV-related HCC who are not amenable to/failed conventional treatment.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- LioCyx-M, HBV antigen-specific TCR-redirected T cells
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LioCyx-M, HBV antigen-specific TCR-redirected T cellsDrug
Via intravenous (IV) infusion
| Study group | Role | What they receive |
|---|---|---|
| LioCyx-M | Experimental | LioCyx-M, HBV antigen-specific TCR-redirected T cells, will be administered every week at a dose of 5-10 x 10^6 cells/kg body weight (BW). Receives: Drug: LioCyx-M, HBV antigen-specific TCR-redirected T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessments of adverse events/serious adverse events
To evaluate the safety of LioCyx-M
Measured: Start of treatment until 28 days post last dose
Objective Response Rate (ORR)
To evaluate the anti-tumor efficacy of LioCyx-M
Measured: Up to 2 years
Secondary outcomes (3)
Duration of Response (DoR)
To evaluate the anti-tumor efficacy of LioCyx-M
Measured: Up to 2 years
Progression Free Survival (PFS)
To evaluate the anti-tumor efficacy of LioCyx-M
Measured: Up to 2 years
Overall Survival (OS)
To evaluate the anti-tumor efficacy of LioCyx-M
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 Jun 2024
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lion TCR Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing GoBroad Hospital
- Responsible party
- Sponsor
- Investigators
- Tina Wang, Study director, Lion TCR Pte. Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961617
- Sponsor's protocol ID
- LTCR-HCC-3-6
- Status last verified
- Jul 2024
- First submitted
- 6 May 2025
- Last updated
- 8 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Autologous HBV-TCR T Cell Therapy (LioCyx-M) for the Treatment of Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT06961617
- Acronym / sponsor ID
- LTCR-HCC-3-6
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Lion TCR Pte. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Beijing GoBroad Hospital
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single center and open-label study to determine the safety and efficacy of mRNA HBV-TCR redirected T-cells in HBV-related HCC who are not amenable to/failed conventional treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LioCyx-M | Experimental | Drug: LioCyx-M, HBV antigen-specific TCR-redirected T cellsLioCyx-M, HBV antigen-specific TCR-redirected T cells, will be administered every week at a dose of 5-10 x 10^6 cells/kg body weight (BW). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- HCC diagnosis confirmed by histology/ cytology or clinically
- HCC that is not amenable to curative surgical and/or locoregional therapies, or progressive disease after surgical and /or locoregional therapies
- Has failed at least one line of systemic therapy for HCC
- ECOG performance status ≤1
- Serum HBsAg positivity
Key exclusion criteria (7 listed)
- 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 tumors
- Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, TKI therapy, and immunotherapy.
- Use of any investigational product (IP) or investigational medical device within 28 days of study drug administration
- Serum HBV DNA levels ≥ 200 IU/ml at screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LioCyx-M, HBV antigen-specific TCR-redirected T cellsVia intravenous (IV) infusion | Drug | LioCyx-M |
Primary outcome
Assessments of adverse events/serious adverse events
Time frame: Start of treatment until 28 days post last dose
To evaluate the safety of LioCyx-M
Objective Response Rate (ORR)
Time frame: Up to 2 years
To evaluate the anti-tumor efficacy of LioCyx-M
3 secondary outcomes
Duration of Response (DoR)
Time frame: Up to 2 years
Progression Free Survival (PFS)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tina Wang study director
Lion TCR Pte. Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LioCyx-M, HBV antigen-specific TCR-redirected T cells in people with Hepatocellular Carcinoma, run by Lion TCR Pte. Ltd. at 1 site in China.
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 8 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Wang Zhe (+86 15902091916, zhe.wang@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: Start of treatment until 28 days post last dose). 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?
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 8 May 2025.