A Phase 1 interventional study of GKL-006 Injection and Transarterial chemoembolization (TACE) in Hepatocellular Carcinoma (HCC) and Unresectable Hepatocellular Cancer, sponsored by Beijing Gene Key Life Technology Co., Ltd. Active, not recruiting at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Beijing Gene Key Life Technology Co., Ltd · Phase 1, Interventional, and Treatment
This is a Phase 1b study of GKL-006 Injection in patients with unresectable hepatocellular carcinoma.
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.
3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.
This study's enrollment of 6 is below the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.
Browse Carcinoma, Hepatocellular studies →Beijing Gene Key Life Technology Co., Ltd is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive GKL-006 Injection in combination with TACE according to the study protocol.
Drug: GKL-006 Injection · Procedure: Transarterial chemoembolization (TACE)
An iNKT cell therapy
Also known as: GKL-006, iNKT Cells
A standard locoregional therapy for hepatocellular carcinoma
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 1 year after enrollment.
Time to Progression (TTP)
The time from enrollment to the first documented disease progression according to mRECIST.
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)
The rate of participants with a best overall response of complete response (CR) or partial response (PR) according to 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.
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.
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
The rate of participants with a best overall response of CR, PR, or stable disease (SD) according to 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
Maximum observed plasma concentration of GKL-006 following intravenous administration according to protocol.
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 to reach the maximum observed plasma concentration of GKL-006 following a single intravenous administration.
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
Area under the plasma concentration-time curve of GKL-006 following a single intravenous administration.
Time frame: 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.
Time frame: From 60 minutes before the first dose through 60 days.
Pharmacodynamic Biomarkers of NK cells
Immune cell subsets
Time frame: From 60 minutes before the first dose through 60 days.
Pharmacodynamic Biomarkers of T cells
Immune cell subsets
Time frame: From 60 minutes before the first dose through 60 days.
Plan to share: No
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This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Beijing Gene Key Life Technology Co., Ltd