NCT07713290

Brief Summary

This is a Phase 1b study of GKL-006 Injection in patients with unresectable hepatocellular carcinoma.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
7mo left

Started Apr 2025

Geographic Reach
1 country

3 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Apr 2025Feb 2027

Study Start

First participant enrolled

April 3, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

July 20, 2026

Status Verified

June 1, 2026

Enrollment Period

1.6 years

First QC Date

June 12, 2026

Last Update Submit

July 14, 2026

Conditions

Hepatocellular Carcinoma (HCC)Unresectable Hepatocellular Cancer

Keywords

GKL-006Unresectable hepatocellular carcinomaHCCImmunotherapyCell therapySafety

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    From enrollment to the first documented disease progression or death from any cause, up to 18 months.

  • Overall Survival

    From enrollment until death or the end of study follow-up, approximatelly 30 months.

  • One-Year Overall Survival Rate (1Y-OS)

    1 year after enrollment.

  • Time to Progression (TTP)

    From enrollment until the first documented disease progression or the end of study follow-up, up to 18 months.

  • Objective Response Rate (ORR)

    From enrollment until disease progression, initiation of new anti-tumor therapy, death, or the end of study follow-up, up to 18 months.

  • +8 more secondary outcomes

Study Arms (1)

GKL-006 Injection Plus TACE

EXPERIMENTAL

Participants will receive GKL-006 Injection in combination with TACE according to the study protocol.

Drug: GKL-006 InjectionProcedure: Transarterial chemoembolization (TACE)

Interventions

GKL-006 InjectionDRUG

An iNKT cell therapy

Also known as: GKL-006, iNKT Cells
GKL-006 Injection Plus TACE
Transarterial chemoembolization (TACE)PROCEDURE

A standard locoregional therapy for hepatocellular carcinoma

GKL-006 Injection Plus TACE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beijing Ditan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100015, China

Location

Beijing You An Hospital

Beijing, Beijing Municipality, 100069, China

Location

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2026

First Posted

July 20, 2026

Study Start

April 3, 2025

Primary Completion (Estimated)

November 12, 2026

Study Completion (Estimated)

February 28, 2027

Last Updated

July 20, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)