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Engineered immune cells take on liver cancer in new trial

NCT ID NCT06084884

Disease control Sponsor: AstraZeneca 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Aug 20, 2026 · Updated 2 times

Summary

This study tests a therapy called AZD5851, which uses a patient's own immune cells (T-cells) that are modified in a lab to recognize and attack liver cancer cells. The trial includes 94 adults with advanced or recurrent liver cancer that has not responded to standard treatments. Participants receive one infusion of these modified cells after a short course of chemotherapy to prepare their immune system. The main goals are to check safety and see if the treatment can shrink tumors.

What this could mean

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

Active substance
AZD5851 (a CAR-T cell therapy targeting GPC3)
What this could lead to
If it works, this could offer a new treatment option for people with advanced liver cancer that hasn't responded to other therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with only 94 participants, so results may not apply to everyone. CAR-T therapies can cause serious side effects like cytokine release syndrome.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 94 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2023

Expected to finish

Dec 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 to 130 years

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: 1. Participant must be 18 years or older and has voluntarily agreed to participate by giving written informed consent. 2. Participants with confirmed advanced/recurrent or metastatic and/or unresectable HCC based on histopathological findings 3. Completed or were unable to tolerate at least one prior line of standard systemic therapy for HCC and/or participant/investigator decision. 4. GPC3-positive tumour as determined by a central laboratory using an analytically validated IHC assay 5. Barcelona Clinic Liver Cancer Stage B (if not amenable to local treatment/surgery) or C prior to apheresis 6. Child-Pugh score: Grade A 7. Participants with HBV and HCV undergoing management of these infections per institutional practice. Exclusion Criteria: 1. Active or prior documented gastrointestinal (GI) variceal bleed or history of upper GI bleeding, ulcers, or esophageal varices with bleeding within 12 months 2. History of liver transplantation or on waiting list 3. Current clinically significant ascites 4. Main portal vein thrombus, or tumor thrombus invasion of mesenteric vein / inferior vena cava 5. Uncontrolled intercurrent illness 6. Active Infections 7. Positive serology for HIV 8. History of hepatic encephalopathy within 12 months prior to treatment allocation 9. History of chronic or recurrent (within the last year) severe autoimmune or immune mediated disease requiring steroids or other immune-suppressive treatments. 10. Prior treatment with any CAR-T therapy directed at any target or any therapy that is targeted to GPC3. 11. Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumour embolisation, or monoclonal antibodies, investigational product) within 5 half-lives or ≤ 21 days (whichever is shortest).

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Conditions

The condition(s) this trial relates to.

hepatocellular carcinoma Liver Neoplasms

As listed by the trial registrant

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

Hepatocellular carcinoma

Contacts and locations

Locations

  • Research Site

    Phoenix, Arizona, 85054, United States

  • Research Site

    Duarte, California, 91010, United States

  • Research Site

    Los Angeles, California, 90089, United States

  • Research Site

    Orange, California, 92868, United States

  • Research Site

    San Francisco, California, 94143, United States

  • Research Site

    Washington D.C., District of Columbia, 20007, United States

  • Research Site

    Jacksonville, Florida, 32224, United States

  • Research Site

    Atlanta, Georgia, 30322, United States

  • Research Site

    Westwood, Kansas, 66205, United States

  • Research Site

    Rochester, Minnesota, 55905, United States

  • Research Site

    Hackensack, New Jersey, 07601, United States

  • Research Site

    New York, New York, 10065, United States

  • Research Site

    Columbus, Ohio, 43210, United States

  • Research Site

    Portland, Oregon, 97239, United States

  • Research Site

    Philadelphia, Pennsylvania, 19104, United States

  • Research Site

    Pittsburgh, Pennsylvania, 15237, United States

  • Research Site

    Kashiwa, 227-8577, Japan

  • Research Site

    Osakasayama-shi, 589-8511, Japan

  • Research Site

    Seoul, 03080, South Korea

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