CompletedNCT07845266Updated Sep 28, 2026

Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GKL-006 Injection in Combination With TACE in Unresectable Hepatocellular Carcinoma

A Phase 1 interventional study of GKL-006 Injection and transarterial chemoembolization in Hepatocellular Carcinoma (HCC) and Unresectable Hepatocellular Carcinoma, sponsored by Beijing Gene Key Life Technology Co., Ltd. Completed at 2 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Beijing Gene Key Life Technology Co., Ltd · Phase 1, Interventional, and Treatment

From the registry’s dates

Registered 2 years 5 months after the study started (first participant enrolled Apr 2024, registered Sep 2026).

Updated Sep 28, 2026Newly registeredGo to Updates ↓

Phase: Phase 1
Study type: Interventional
Enrollment: 13
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

This Phase Ia study evaluated the safety and tolerability of a single escalating dose via intravenous infusion of the autologous invariant natural killer T cells (iNKT-cell) product GKL-006 in combination with transarterial chemoembolisation (TACE) in participants with unresectable hepatocellular carcinoma (uHCC). The study aimed to characterise dose-limiting toxicities (DLT), determine the maximum tolerated dose (MTD), and assess pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumour activity.

Read the detailed description

The study used a 3+3 dose-escalation design with three GKL-006 dose levels: (1.0±0.3)×10\^8, (3.0±0.9)×10\^8, and (9.0±2.7)×10\^8 iNKT cells/m\^2. Each cohort was planned to include three participants receiving GKL-006 plus TACE and one concurrent participant receiving TACE alone. All participants underwent one TACE procedure during the 28-day treatment period, which also served as the DLT observation period. Nineteen participants were screened and 13 were enrolled; one enrolled participant underwent leukapheresis but did not receive the cell infusion, leaving 12 participants who completed the protocol-specified treatment and DLT evaluation. After treatment, efficacy was assessed every 8 weeks, with continued safety, imaging, and survival follow-up.

Conditions studied

Hepatocellular Carcinoma (HCC)
Unresectable Hepatocellular Carcinoma

Browse trials for

Carcinoma, Hepatocellular 3,182

Keywords

invariant natural killer T cells
iNKT cells
GKL-006
Unresectable Hepatocellular Carcinoma
TACE

In context

Carcinoma, Hepatocellular

3,182 studies on the registry are indexed under Carcinoma, Hepatocellular; 954 are open to participants now.

This study's enrollment of 13 is below the median of 55 across 2,298 interventional studies indexed under Carcinoma, Hepatocellular.

Browse Carcinoma, Hepatocellular studies →

Lead sponsor

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.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Voluntarily participates and provides written informed consent.
Aged ≥18 years, male or female.
Unresectable primary hepatocellular carcinoma (HCC) confirmed by histology, cytology, or imaging (dynamic CT or MRI). Unresectable disease includes technically unresectable disease or disease for which surgery is not feasible or is declined for other reasons.
CNLC stage II-IIIa.
Suitable for TACE and total tumour volume ≤50% of the liver volume.
At least one measurable HCC lesion per mRECIST.
Tumour confined to the liver, with no extrahepatic spread or major vascular invasion (Vp3 or Vp4 portal vein tumour thrombus).
Child-Pugh score ≤9 within 7 days before enrolment.
ECOG performance status of 0-2
Life expectancy ≥24 weeks.
Adequate haematologic and organ function:
- WBC ≥2 × 10\^9/L;
- haemoglobin ≥90 g/L;
- ANC ≥1.5 × 10\^9/L;
- platelets ≥50 × 10\^9/L;
- PT or APTT ≤2 × ULN;
- serum creatinine ≤ULN;
- AST and ALT ≤5 × ULN;
- total bilirubin ≤3 × ULN.
For patients with HBV or HCV infection, viral load must not exceed the lower limit of detection (HBV DNA ≤2,000 IU/mL and HCV RNA ≤100 IU/mL).
No radiotherapy, chemotherapy, targeted therapy, or immunosuppressive therapy within 4 weeks before screening.
Participants of reproductive potential must use at least one medically accepted contraceptive method during study treatment and for 6 months after treatment.
Able to communicate with investigators, comply with study visits, and understand and follow study requirements.

Exclusion criteria

Exclusion Criteria:

Hypersensitivity to immunotherapy or related medications.
Another malignancy within the previous 5 years or a concurrent uncontrolled malignancy, except cured basal cell carcinoma, carcinoma in situ, or breast cancer with no recurrence for >3 years after curative surgery.
History of organ transplantation.
Any contraindication to TACE, as determined by the investigator.
Histologically or cytologically confirmed combined HCC-cholangiocarcinoma, fibrolamellar HCC, sarcomatoid HCC, or another mixed carcinoma.
Active, known, or suspected autoimmune disease.
Systemic corticosteroids (>10 mg/day prednisone or equivalent) or other immunosuppressive therapy within 4 weeks before screening.
Infiltrative tumour growth or extrahepatic metastasis on imaging.
Hepatic encephalopathy.
Symptomatic ascites or pleural effusion.
History or current evidence of idiopathic pulmonary fibrosis, interstitial pneumonitis, pneumoconiosis, drug-induced pneumonitis, or active pneumonitis on screening CT.
Poorly controlled cardiovascular disease.
Uncontrolled hypertension despite medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).
Urine protein ≥2+ within 7 days before enrolment with confirmed 24-hour urine protein >1.0 g.
Any of the following bleeding risks:
CTCAE v5.0 Grade ≥2 bleeding within 4 weeks before enrolment;
tumour invasion of a major vessel or a high risk of life-threatening bleeding, as determined by the investigator;
gastrointestinal bleeding within 6 months;
known hereditary or acquired bleeding or thrombotic disorder.
Arterial or venous thromboembolic event within 6 months.
Signs or symptoms of intestinal or gastrointestinal obstruction within 1 month.
Active infection within 2 weeks before enrolment.
AST or ALT >5 × ULN within 7 days before enrolment.
Congenital or acquired immunodeficiency, including HIV infection; syphilis; or another serious active infection.
Pregnant or breastfeeding women.
Receipt of a live attenuated vaccine or COVID-19 vaccine within 4 weeks before screening.
Participation in another interventional clinical trial.
Any serious concomitant disease, clinically significant laboratory abnormality, psychiatric condition, or family or social circumstance that may compromise participant safety or interfere with data or sample collection, as determined by the investigator.
Any other condition that, in the investigator's opinion, makes the participant unsuitable for enrolment or study completion.

Study design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 13 participants (actual)

Study arms

Active comparator
TACE
Participants will receive transarterial chemoembolization (TACE) alone according to the study protocol.
Drug: transarterial chemoembolization
Experimental
Low-Dose Cohort
Participants will receive TACE and (1.0±0.3)×10\^8 iNKT cells/m\^2 of GKL-006 Injection sequentially according to the study protocol.
Biological: GKL-006 Injection · Drug: transarterial chemoembolization
Experimental
Medium-Dose Cohort
Participants will receive TACE and (3.0±0.9)×10\^8 iNKT cells/m\^2 of GKL-006 Injection sequentially according to the study protocol.
Biological: GKL-006 Injection · Drug: transarterial chemoembolization
Experimental
High-Dose Cohort
Participants will receive TACE and (9.0±2.7)×10\^8 iNKT cells/m\^2 of GKL-006 Injection sequentially according to the study protocol.
Biological: GKL-006 Injection · Drug: transarterial chemoembolization

Interventions

BiologicalGKL-006 Injection
Autologous iNKT cells collected and reinfused after in vitro cultivation.
Drugtransarterial chemoembolization
A standard locoregional therapy for hepatocellular carcinoma.

What researchers measure

Primary outcomes

Maximum Tolerated Dose（MTD）of GKL-006
The MTD determined from protocol-defined DLTs under the 3+3 dose-escalation design.
Time frame: From the GKL-006 infusion until 28 days.
Incidence of Dose-Limiting Toxicities (DLTs)
Observe the dose limiting toxicity, and Incidence of dose-limiting toxicities(DLT) will be assessed
Time frame: From GKL-006 infusion through Day 28

Secondary outcomes

Incidence and Severity of Adverse Events
Defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0).
Time frame: From GKL-006 infusion though 28 days.
Cmax
maximum observed peripheral blood concentration of GKL-006 in trial participants within GKL-006 injection
Time frame: From 1 hour pre-dose of GKL-006 injection through 12 weeks
Tmax
time to observed Cmax of GKL-006 in trial participants within GKL-006 injection
Time frame: From 1 hour pre-dose of GKL-006 injection through 12 weeks
AUC
Pharmacokinetic characteristics of the area under the peripheral blood cell concentration-time curve
Time frame: From 1 hour pre-dose of GKL-006 injection through 12 weeks
t1/2z
terminal elimination half-life of GKL-006
Time frame: From 1 hour pre-dose of GKL-006 injection through 12 weeks
Changes in Peripheral Blood Immune Cell Subsets
Changes from baseline in NK cells (CD3-CD56+), activated NK cells (CD3-CD56+CD69+), CD8+ T cells, and MDSCs (CD11b+CD33+), assessed as cell counts and/or percentages.
Time frame: From 1 hour pre-dose of GKL-006 injection through 12 weeks
Changes in Plasma Cytokines and Cytotoxic Effector Molecules
Changes from baseline in plasma IFN-γ, perforin, granzyme B, TNF-α, IL-1β, IL-2, IL-4, IL-6, IL-8, IL-10, IL-12p70, and IL-13 concentrations.
Time frame: From 1 hour pre-dose of GKL-006 injection through 12 weeks
PFS
from enrollment to disease progression assessed according to mRECIST and iRECIST or death from any cause, whichever occurs first.
Time frame: Approximate 14 months
DCR
The rate of participants with a best overall response of CR, PR, or SD.
Time frame: Approximate 14 months
ORR
The rate of participants with a best overall response of complete response (CR) or partial response (PR).
Time frame: Approximate 14 months
DOR
The time from the first documented CR or PR to disease progression or death from any cause, whichever occurs first.
Time frame: Approximate 14 months
TTP
From enrollment to disease progression
Time frame: Approximate 14 months
1Y-OS
The proportion of participants who are alive 1 year after enrollment.
Time frame: Approximate 14 months
OS
The time from enrollment to death.
Time frame: From enrollment to death, approximate 5 years.

Study locations

2 sites

Beijing Ditan Hospital Chaoyang Campus
Beijing, Beijing Municipality 100015, China
Beijing Youan Hospital, Capital Medical University
Beijing, Beijing Municipality 100069, China

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

1 registry update since Sep 25, 2026

Registered

First appeared on the registry. No changes since

Sep 28, 2026

Show all 1 update

Sep 28, 2026
First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT07845266
Lead sponsor: Beijing Gene Key Life Technology Co., Ltd
Responsible party: Sponsor
First posted: Sep 28, 2026
Start date: Apr 16, 2024
Primary completion: Apr 9, 2025
Completion: Dec 4, 2025
Last update: Sep 28, 2026

Study contacts

Jun Lv, MD

principal investigator · Beijing YouAn Hospital

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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