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Hepatocellular Carcinoma (HCC)Phase 1NCT07845266

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

A Phase 1 study testing GKL-006 Injection and transarterial chemoembolization in people with Hepatocellular Carcinoma (HCC) and Unresectable Hepatocellular Carcinoma, run by Beijing Gene Key Life Technology Co., Ltd at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
GKL-006 Injection and transarterial chemoembolization
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
2 sitesChina
Study dates
16 Apr 2024to 4 Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Beijing Ditan Hospital Chaoyang Campus

    Beijing, Beijing Municipality, 100015

  • Beijing Youan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100069

Other trials in China

About this study

Official title: A Phase 1, Open-label, Controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics and Pharmacodynamics of GKL-006 Injection in Combination With Transarterial Chemoembolization (TACE) Versus TACE Alone in Patients With Unresectable Hepatocellular Carcinoma

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.

Being tested
GKL-006 Injection, transarterial chemoembolization
Keywords
invariant natural killer T cells, iNKT cells, GKL-006, Unresectable Hepatocellular Carcinoma, TACE
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 InjectionBiological

    Autologous iNKT cells collected and reinfused after in vitro cultivation.

  • transarterial chemoembolizationDrug

    A standard locoregional therapy for hepatocellular carcinoma.

Study groups in NCT07845266
Study groupRoleWhat they receive
TACEActive comparatorParticipants will receive transarterial chemoembolization (TACE) alone according to the study protocol.
Receives: Drug: transarterial chemoembolization
Low-Dose CohortExperimentalParticipants will receive TACE and (1.0±0.3)×10^8 iNKT cells/m^2 of GKL-006 Injection sequentially according to the study protocol.
Receives: Biological: GKL-006 Injection; Drug: transarterial chemoembolization
Medium-Dose CohortExperimentalParticipants will receive TACE and (3.0±0.9)×10^8 iNKT cells/m^2 of GKL-006 Injection sequentially according to the study protocol.
Receives: Biological: GKL-006 Injection; Drug: transarterial chemoembolization
High-Dose CohortExperimentalParticipants will receive TACE and (9.0±2.7)×10^8 iNKT cells/m^2 of GKL-006 Injection sequentially according to the study protocol.
Receives: Biological: GKL-006 Injection; Drug: transarterial chemoembolization

What is being measured

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

  1. Maximum Tolerated Dose（MTD）of GKL-006

    The MTD determined from protocol-defined DLTs under the 3+3 dose-escalation design.

    Measured: From the GKL-006 infusion until 28 days.

  2. Incidence of Dose-Limiting Toxicities (DLTs)

    Observe the dose limiting toxicity, and Incidence of dose-limiting toxicities(DLT) will be assessed

    Measured: From GKL-006 infusion through Day 28

Secondary outcomes (14)

  1. Incidence and Severity of Adverse Events

    Defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0).

    Measured: From GKL-006 infusion though 28 days.

  2. Cmax

    maximum observed peripheral blood concentration of GKL-006 in trial participants within GKL-006 injection

    Measured: From 1 hour pre-dose of GKL-006 injection through 12 weeks

  3. Tmax

    time to observed Cmax of GKL-006 in trial participants within GKL-006 injection

    Measured: From 1 hour pre-dose of GKL-006 injection through 12 weeks

  4. AUC

    Pharmacokinetic characteristics of the area under the peripheral blood cell concentration-time curve

    Measured: From 1 hour pre-dose of GKL-006 injection through 12 weeks

  5. t1/2z

    terminal elimination half-life of GKL-006

    Measured: From 1 hour pre-dose of GKL-006 injection through 12 weeks

  6. 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.

    Measured: From 1 hour pre-dose of GKL-006 injection through 12 weeks

  7. 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.

    Measured: From 1 hour pre-dose of GKL-006 injection through 12 weeks

  8. PFS

    from enrollment to disease progression assessed according to mRECIST and iRECIST or death from any cause, whichever occurs first.

    Measured: Approximate 14 months

  9. DCR

    The rate of participants with a best overall response of CR, PR, or SD.

    Measured: Approximate 14 months

  10. ORR

    The rate of participants with a best overall response of complete response (CR) or partial response (PR).

    Measured: Approximate 14 months

  11. DOR

    The time from the first documented CR or PR to disease progression or death from any cause, whichever occurs first.

    Measured: Approximate 14 months

  12. TTP

    From enrollment to disease progression

    Measured: Approximate 14 months

  13. 1Y-OS

    The proportion of participants who are alive 1 year after enrollment.

    Measured: Approximate 14 months

  14. OS

    The time from enrollment to death.

    Measured: From enrollment to death, approximate 5 years.

Timeline

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

  1. First posted28 Sep 2026
  2. Study start16 Apr 2024
  3. Primary completion9 Apr 2025
  4. Study completion4 Dec 2025

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This Phase 1a study uses a modified 3+3 dose-escalation design with three experimental dose cohorts and one active comparator arm. Within each dose cohort, participants were randomized to receive TACE plus GKL-006 at the designated dose level or TACE alone.
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07845266
Sponsor's protocol ID
GKL006HCC01
Status last verified
Sep 2026
First submitted
22 Sep 2026
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GKL-006 Injection and transarterial chemoembolization in people with Hepatocellular Carcinoma (HCC) and Unresectable Hepatocellular Carcinoma, run by Beijing Gene Key Life Technology Co., Ltd at 2 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 23 inclusion and 29 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: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Maximum Tolerated Dose（MTD）of GKL-006 (time frame: From the GKL-006 infusion until 28 days.). 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 NCT07845266.

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 28 Sep 2026.

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