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Immune cell therapy takes on untreatable liver cancer

NCT ID NCT07713290

Disease control Sponsor: Beijing Gene Key Life Technology Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 20, 2026 · Last updated Jul 21, 2026 · Updated 1 time

Summary

This study tests an experimental treatment called GKL-006, made from a person's own immune cells (iNKT cells), for liver cancer that cannot be surgically removed. Participants receive GKL-006 injections along with a standard procedure that blocks the tumor's blood supply (TACE). The main goal is to check safety and tolerability, with early looks at whether the cancer shrinks or progression slows.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental iNKT cell therapy called GKL-006, given by injection, combined with a standard liver cancer procedure called transarterial chemoembolization (TACE)
What this could lead to
If this works, it could offer a new treatment option for people with liver cancer that cannot be removed by surgery.
What could go wrong
This is a very early, small study (6 people) focused mainly on safety. The treatment may not shrink tumors or improve survival, and cell therapies can cause serious side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

6 people

The number who actually took part.

Started

Apr 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hepatocellular carcinoma (HCC) Unresectable hepatocellular cancer

Contacts and locations

Locations

  • Beijing Ditan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100015, China

  • Beijing You An Hospital

    Beijing, Beijing Municipality, 100069, China

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, 030001, China

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