Hepatocellular Carcinoma (HCC)Phase 1NCT07713290
A Phase 1b Study of GKL-006 Injection in Patients With Unresectable Hepatocellular Carcinoma
A Phase 1 study testing GKL-006 Injection and Transarterial chemoembolization (TACE) in people with Hepatocellular Carcinoma (HCC) and Unresectable Hepatocellular Cancer, run by Beijing Gene Key Life Technology Co., Ltd at 3 sites in China.
Trial summary
This is a Phase 1b study of GKL-006 Injection in patients with unresectable hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma (HCC), Unresectable Hepatocellular Cancer
- What is being tested?
- GKL-006 Injection and Transarterial chemoembolization (TACE)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 3 sitesChina
- Study dates
- 3 Apr 2025to 28 Feb 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily participates in the study and provides written informed consent.
- Has pathologically, cytologically, or radiologically confirmed unresectable hepatocellular carcinoma.
- Has CNLC stage II to IIIa disease.
- Has not received transarterial chemoembolization within 6 months before screening.
- Has at least one measurable lesion according to mRECIST.
- Child-Pugh class A or B.
- ECOG performance status of 0 - 2.
- Has not received radiotherapy, chemotherapy, targeted therapy, or immunosuppressive therapy within 4 weeks before screening.
Who cannot join
- Has a known allergy to the investigational product or related components, including human serum albumin.
- Has another incurable malignancy within 5 years before screening or concurrently, except for cured basal cell carcinoma of the skin, carcinoma in situ, or breast cancer without recurrence for more than 3 years after radical surgery.
- Has a previous diagnosis of mixed or rare histologic subtypes, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or combined hepatocellular-cholangiocarcinoma.
- Has major vascular invasion on imaging.
- Has hepatic encephalopathy within 4 weeks before screening.
- Has clinically symptomatic ascites or pleural effusion requiring drainage, or has undergone thoracic or abdominal fluid drainage within 2 weeks before enrollment.
Trial locations and contacts
3 sites in 1 country.
China3 sites
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100015
Beijing You An Hospital
Beijing, Beijing Municipality, 100069
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
About this study
Official title: An Open-Label, Multiple-Dose Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GKL-006 Injection in Patients With Unresectable Hepatocellular Carcinoma
This is a Phase 1b study of GKL-006 Injection in patients with unresectable hepatocellular carcinoma.
Read the detailed description
This Phase 1b study evaluates multiple doses of GKL-006 Injection in participants with unresectable hepatocellular carcinoma (HCC).
The purpose of this study is to evaluate the safety and tolerability of multiple doses of GKL-006 Injection. The study will also evaluate pharmacokinetic and pharmacodynamic characteristics of GKL-006 Injection, how it affects the body, and whether it shows preliminary anti-tumor activity in patients with HCC according to mRECIST.
Participants will receive GKL-006 Injection and TACE treatment. They will be followed for adverse events, tumor response, disease progression, subsequent anti-tumor therapy, and survival.
- Being tested
- GKL-006 Injection, Transarterial chemoembolization (TACE)
- Keywords
- GKL-006, Unresectable hepatocellular carcinoma, HCC, Immunotherapy, Cell therapy, Safety
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GKL-006 InjectionDrug
Also called GKL-006, iNKT Cells
An iNKT cell therapy
Transarterial chemoembolization (TACE)Procedure or surgery
A standard locoregional therapy for hepatocellular carcinoma
| Study group | Role | What they receive |
|---|---|---|
| GKL-006 Injection Plus TACE | Experimental | Participants will receive GKL-006 Injection in combination with TACE according to the study protocol. Receives: Drug: GKL-006 Injection; Procedure: Transarterial chemoembolization (TACE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Treatment-Related Adverse Events and Safety/Tolerability Risks
Treatment-related adverse events and laboratory abnormalities will be assessed and graded according to NCI CTCAE v5.0. Safety and tolerability risks include study treatment-related adverse events or laboratory abnormalities occurring.
Measured: From the start of study treatment through 14 days after the fourth treatment; treatment-related adverse events will continue to be assessed according to the study protocol.
Secondary outcomes (13)
Progression-Free Survival (PFS) Based on mRECIST
PFS defined as the time from enrollment to disease progression assessed according to mRECIST or death from any cause, whichever occurs first.
Measured: From enrollment to the first documented disease progression or death from any cause, up to 18 months.
Overall Survival
The time from enrollment to death from any cause.
Measured: From enrollment until death or the end of study follow-up, approximatelly 30 months.
One-Year Overall Survival Rate (1Y-OS)
The proportion of participants who are alive 1 year after enrollment.
Measured: 1 year after enrollment.
Time to Progression (TTP)
The time from enrollment to the first documented disease progression according to mRECIST.
Measured: From enrollment until the first documented disease progression or the end of study follow-up, up to 18 months.
Objective Response Rate (ORR)
The rate of participants with a best overall response of complete response (CR) or partial response (PR) according to mRECIST.
Measured: From enrollment until disease progression, initiation of new anti-tumor therapy, death, or the end of study follow-up, up to 18 months.
Duration of Response (DOR) Based on mRECIST
The time from the first documented CR or PR according to mRECIST to disease progression or death from any cause, whichever occurs first.
Measured: From first documented response until disease progression, death, or the end of study follow-up, up to 18 months.
Disease Control Rate (DCR) Based on mRECIST
The rate of participants with a best overall response of CR, PR, or stable disease (SD) according to mRECIST.
Measured: From enrollment until disease progression, initiation of new anti-tumor therapy, death, or the end of study follow-up, up to 18 months.
Pharmacokinetic characterization of maximum observed plasma concentration (Cmax) of GKL-006
Maximum observed plasma concentration of GKL-006 following intravenous administration according to protocol.
Measured: From 60 minutes before the first dose through 60 days.
Pharmacokinetic characterization of time to maximum observed plasma concentration (Tmax) of GKL-006
Time to reach the maximum observed plasma concentration of GKL-006 following a single intravenous administration.
Measured: From 60 minutes before the first dose through 60 days.
Pharmacokinetic characterization of area under the plasma concentration-time curve (AUC) of GKL-006
Area under the plasma concentration-time curve of GKL-006 following a single intravenous administration.
Measured: From 60 minutes before the first dose through 60 days.
Pharmacokinetic characterization of terminal elimination half-life (t½) of GKL-006
Terminal elimination half-life of GKL-006 calculated from plasma concentration-time data following a single intravenous administration.
Measured: From 60 minutes before the first dose through 60 days.
Pharmacodynamic Biomarkers of NK cells
Immune cell subsets
Measured: From 60 minutes before the first dose through 60 days.
Pharmacodynamic Biomarkers of T cells
Immune cell subsets
Measured: From 60 minutes before the first dose through 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start3 Apr 2025
- Primary completion12 Nov 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular Carcinoma (HCC)Studies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Gene Key Life Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07713290
- Sponsor's protocol ID
- GKL006HCC02
- Status last verified
- Jun 2026
- First submitted
- 12 Jun 2026
- Last updated
- 20 Jul 2026
- 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 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multiple-Dose Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GKL-006 Injection in Patients With Unresectable Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07713290
- Acronym / sponsor ID
- GKL006HCC02
- Keywords
- GKL-006, Unresectable hepatocellular carcinoma, HCC, Immunotherapy, Cell therapy, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Beijing Gene Key Life Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 12 Nov 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 20 Jul 2026 (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 Phase 1b study of GKL-006 Injection in patients with unresectable hepatocellular carcinoma.
Detailed description
This Phase 1b study evaluates multiple doses of GKL-006 Injection in participants with unresectable hepatocellular carcinoma (HCC).
The purpose of this study is to evaluate the safety and tolerability of multiple doses of GKL-006 Injection. The study will also evaluate pharmacokinetic and pharmacodynamic characteristics of GKL-006 Injection, how it affects the body, and whether it shows preliminary anti-tumor activity in patients with HCC according to mRECIST.
Participants will receive GKL-006 Injection and TACE treatment. They will be followed for adverse events, tumor response, disease progression, subsequent anti-tumor therapy, and survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GKL-006 Injection Plus TACE | Experimental | Drug: GKL-006 Injection, Procedure: Transarterial chemoembolization (TACE)Participants will receive GKL-006 Injection in combination with TACE according to the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Voluntarily participates in the study and provides written informed consent.
- Has pathologically, cytologically, or radiologically confirmed unresectable hepatocellular carcinoma.
- Has CNLC stage II to IIIa disease.
- Has not received transarterial chemoembolization within 6 months before screening.
- Has at least one measurable lesion according to mRECIST.
Key exclusion criteria (6 listed)
- Has a known allergy to the investigational product or related components, including human serum albumin.
- Has another incurable malignancy within 5 years before screening or concurrently, except for cured basal cell carcinoma of the skin, carcinoma in situ, or breast cancer without recurrence for more than 3 years after radical surgery.
- Has a previous diagnosis of mixed or rare histologic subtypes, including fibrolamellar hepatocellular carcinoma, sarcomatoid hepatocellular carcinoma, or combined hepatocellular-cholangiocarcinoma.
- Has major vascular invasion on imaging.
- Has hepatic encephalopathy within 4 weeks before 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 |
|---|---|---|
| GKL-006 InjectionAlso: GKL-006, iNKT CellsAn iNKT cell therapy | Drug | GKL-006 Injection Plus TACE |
| Transarterial chemoembolization (TACE)A standard locoregional therapy for hepatocellular carcinoma | Procedure or surgery | GKL-006 Injection Plus TACE |
Primary outcome
Incidence and Severity of Treatment-Related Adverse Events and Safety/Tolerability Risks
Time frame: From the start of study treatment through 14 days after the fourth treatment; treatment-related adverse events will continue to be assessed according to the study protocol.
Treatment-related adverse events and laboratory abnormalities will be assessed and graded according to NCI CTCAE v5.0. Safety and tolerability risks include study treatment-related adverse events or laboratory abnormalities occurring.
13 secondary outcomes
Progression-Free Survival (PFS) Based on mRECIST
Time frame: From enrollment to the first documented disease progression or death from any cause, up to 18 months.
Overall Survival
Time frame: From enrollment until death or the end of study follow-up, approximatelly 30 months.
One-Year Overall Survival Rate (1Y-OS)
Time frame: 1 year after enrollment.
Time to Progression (TTP)
Time frame: From enrollment until the first documented disease progression or the end of study follow-up, up to 18 months.
Objective Response Rate (ORR)
Time frame: From enrollment until disease progression, initiation of new anti-tumor therapy, death, or the end of study follow-up, up to 18 months.
Duration of Response (DOR) Based on mRECIST
Time frame: From first documented response until disease progression, death, or the end of study follow-up, up to 18 months.
Disease Control Rate (DCR) Based on mRECIST
Time frame: From enrollment until disease progression, initiation of new anti-tumor therapy, death, or the end of study follow-up, up to 18 months.
Pharmacokinetic characterization of maximum observed plasma concentration (Cmax) of GKL-006
Time frame: From 60 minutes before the first dose through 60 days.
Pharmacokinetic characterization of time to maximum observed plasma concentration (Tmax) of GKL-006
Time frame: From 60 minutes before the first dose through 60 days.
Pharmacokinetic characterization of area under the plasma concentration-time curve (AUC) of GKL-006
Time frame: From 60 minutes before the first dose through 60 days.
Pharmacokinetic characterization of terminal elimination half-life (t½) of GKL-006
Time frame: From 60 minutes before the first dose through 60 days.
Pharmacodynamic Biomarkers of NK cells
Time frame: From 60 minutes before the first dose through 60 days.
Pharmacodynamic Biomarkers of T cells
Time frame: From 60 minutes before the first dose through 60 days.
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 20 Jul 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GKL-006 Injection and Transarterial chemoembolization (TACE) in people with Hepatocellular Carcinoma (HCC) and Unresectable Hepatocellular Cancer, run by Beijing Gene Key Life Technology Co., Ltd at 3 sites 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 6 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: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Severity of Treatment-Related Adverse Events and Safety/Tolerability Risks (time frame: From the start of study treatment through 14 days after the fourth treatment; treatment-related adverse events will continue to be assessed according to the study protocol.). 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 20 Jul 2026.