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Advanced Hepatocellular CarcinomaPhase 1NCT04756648

Phase I Clinical Trial of CT0180 Cells in the Treatment of Hepatocellular Carcinoma

A Phase 1 study testing CT0180 Cells in people with Advanced Hepatocellular Carcinoma, run by Zhejiang University at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A Phase I Clinical Study ofCT0180 cells in Patients with Advanced Hepatocellular Carcinoma Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Hepatocellular Carcinoma
What is being tested?
CT0180 Cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteChina
Study dates
10 Mar 2021to 1 Jun 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 75 years, either sex；
  • Patients with clinically or pathologically confirmed hepatocellular carcinoma were treated with surgery or local treatment It is not suitable for surgery or local radical treatment;
  • Progression or intolerance after at least one previous systemic treatment, or due to specific reasons unable to receive systemic treatment. Systemic therapy can include: Programmed Death 1（PD-1） / programmed cell death-Ligand 1（PD-L1） monoclonal antibody Antibodies, molecular targeted drugs (e.g. sorafenib, regofinib, renvastinib)and conventional chemotherapy, etc;
  • According to Barcelona Clinic Liver Cancer（BCLC）, the patients are classified into Grade C or Grade B unsuitable for local treatment/progressive disease after local treatment;
  • In tumor tissue samples GPC3 is detected positive by immunohistochemistry (IHC);
  • According to Response Evaluation Criteria in SolidTumors（RECIST1.1）,patients have at least one evaluable target lesion, defined as: the longest diameter of non-lymph node lesion ≥ 10 mm, or the shortest diameter of lymph node lesion ≥ 15 mm); hepatic lesions require arterial phase contrast enhancement;
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  • Expected survival is > 12 weeks;
  • Cirrhosis status Child-Pugh score: Grade A;
  • Eastern Cooperative Oncology Group（ ECOG） Performance Status score: 0 to 1 point;
  • If the patient is HBsAg positive or HBcAb positive, HBV-DNA should be <2000 IU/ml. HBsAg positive patients must receive antiviral treatment ;
  • Acceptable routine blood test showing no contraindication to the lymphodepletion pretreatment and adequate liver, renal, cardiovascular, respiratory function;
  • Have venous accesses for apheresis;
  • Subjects of childbearing age must undergo a serum pregnancy test within 14 days before the initiation of the study and the result must be negative. In addition, they should be willing to use a reliable method of contraception during the trial (within 52 weeks after cell infusion); male subjects whose spouses are women of childbearing age should undergo sterilization surgery or agree to use a reliable method of contraception during the trial;
  • Understand and sign informed consent.

Who cannot join

  • Pregnant or breast-feeding women;
  • Hepatitis virus C antibodies ,human immunodeficiency virus（HIV） antibodies or Syphilis Serological tests are positive;
  • Any uncontrol active infection, including but not limited to active tuberculosis;
  • Have clinically significant thyroid dysfunction except the stable control after treatment;
  • Previous or present hepatic encephalopathy;
  • Current clinically significant ascites;
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  • Imaging results:≥50% of the liver is replaced by tumor or portal vein main tumor thrombus, or metastases to the central nervous system, or tumor thrombus invasion of mesenteric vein / inferior vena cava;
  • Patients with a history of organ transplantation or waiting for organ transplantation (including liver transplantation);
  • The side effects caused by the previous treatment of the subjects did not return to Common Terminology Criteria for Adverse Events（CTCAE） ≤1; except hair loss and other tolerable events determined by investigator;
  • Patients who had received systemic steroids or other immunosuppressive agents within 7 days before apheresis, except inhaled steroids;
  • History of severe allergy ,allergic to CT0180 cell fluid adjuvant such as Dimethyl sulfoxide（DMSO）;
  • Has signs of central nervous system disease or an abnormal neurological examination with clinical significance;
  • Subjects with unstable or active ulcers, gastrointestinal bleeding, or pump inhibitor intolerance;
  • Patients with a history of organ transplantation or waiting for organ transplantation;
  • Previously received anti-PD-1/ PD-L1 monoclonal antibody therapy within 4 weeks or local treatment and systemic chemotheray within 2 weeks or immunotheray and molecular targeted drugs within 1 week before apheresis;
  • Previously received GPC3 targeted therapy;
  • Major surgery or significant trauma occurred within 4 weeks before apheresis, or it is expected that major surgery needs to be performed during the trial;
  • Patients who had incurable malignant tumors in the past 5 years or at the same time, except cervical cancer in situ and basal cell carcinoma of skin;
  • Other serious diseases that may restrict the subjects from participating in the trial ；
  • The researcher assessed that the subjects were unable or unwilling to comply with the requirements of the trial protocol.

Trial locations and contacts

1 site in 1 country.

China1 site

  • First affiliated hospital, Zhejiang University

    Hangzhou, Zhejiang, 310006

Other trials in China

About this study

Official title: An Open, Dose Escalation/Dose Exploration, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single/Multiple Infusion of CT0180 Injection in Patients With Advanced Hepatocellular Carcinoma

A Phase I Clinical Study ofCT0180 cells in Patients with Advanced Hepatocellular Carcinoma

Read the detailed description

Primary objectives:

Evaluate the safety and tolerance of CT0180 cells in patients with advanced hepatocellular carcinoma within 28 days after the first infusion

Secondary objectives:

  • Evaluate the metabolic kinetics of CT0180 cells ; · Evaluate overall safety and tolerability ; · Evaluate the initial efficacy of CT0180 cell infusion in the treatment of advanced hepatocellular carcinoma with positive Glypican-3（GPC3 ）expression.
Being tested
CT0180 Cells
Keywords
Advanced Hepatocellular Carcinoma, CT0180 Cells, GPC3

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CT0180 CellsDrug

    Also called CT0180 humanized anti GPC3 autogenous T Cell injection

    Five dose levels were tentatively determined.

Study groups in NCT04756648
Study groupRoleWhat they receive
CT0180 cellsExperimentalCT0180 Cells infusion after lymphocyte-depleting with fludarabine and cyclophosphamide.
Receives: Drug: CT0180 Cells

What is being measured

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

  1. Dose-Limiting Toxicity（DLT）

    Safety

    Measured: 28 days

  2. Maximal Tolerable Dose（MTD）

    tolerability evaluation

    Measured: 28 days

  3. Adverse Event（AE）

    Incidence rate

    Measured: 28 days

  4. Adverse Event of Special Interest （ AESI）

    Incidence rate

    Measured: 28 days

Secondary outcomes (8)

  1. Number of cells

    Pharmacokinetics is the "Implantation endpoint" which is defined as the number of copies of the CT0180 DeoxyriboNucleic Acid（DNA）in peripheral blood detected at each visit after infusion until any two consecutive test results are negative or below the detection limit. Duration of CT0180 Cell persistence is the period from the day of infusion to the first negative test result or result lower than the detection limit

    Measured: 52 weeks

  2. Treatment Emergent Adverse Event(TEAE)

    Incidence rate

    Measured: 52 weeks

  3. Antitumor efficacy-Objective response rate (ORR)

    The number of cases in which tumor size is reduced to partial response (PR) or complete response (CR) / the total number of evaluable cases (%). In the event of partial response( PR) or complete response (CR), the subjects should confirm it no less than 4 weeks after the first evaluation

    Measured: 52 weeks

  4. Antitumor efficacy-Duration of response (DOR)

    The period from the first evaluation of complete response ( CR) or partial response (PR) to the first evaluation of progressive disease (PD)or death of any cause.

    Measured: 52 weeks

  5. Antitumor efficacy-Progression-free survival (PFS)

    The period from the day when the subject receives the first study treatment to the first recorded tumor progression (whether treated or not) or death of any cause, which occurs first

    Measured: 52 weeks

  6. Antitumor efficacy-Overall survival (OS)

    The period from the first study treatment to any cause of death

    Measured: 52 weeks

  7. Antitumor efficacy-Disease control rate (DCR)

    The number of cases in which response (PR + CR) and stable disease (SD) are achieved from the start of cell infusion/the total number of evaluable cases (%).

    Measured: 52 weeks

  8. Antitumor efficacy-Duration of disease control (DDC)

    The period from the first evaluation of CR, PR, or SD to the first evaluation of PD or any cause of death

    Measured: 52 weeks

Timeline

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

  1. First posted16 Feb 2021
  2. Study start10 Mar 2021
  3. Primary completion31 Mar 2023
  4. Study completion1 Jun 2026 (estimated)

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
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04756648
Sponsor's protocol ID
CT0180-CG1203
Status last verified
Sep 2025
First submitted
11 Feb 2021
Last updated
29 Sep 2025
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 CT0180 Cells in people with Advanced Hepatocellular Carcinoma, run by Zhejiang University at 1 site 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 14 inclusion and 20 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: under way, not looking for participants, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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?

Dose-Limiting Toxicity（DLT） (time frame: 28 days). The study lists 4 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 NCT04756648.

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 29 Sep 2025.

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