AzTrials
AzTrials

Advanced Hepatocellular CarcinomaPhase 1NCT06461624

Clinical Trial of Autologous GPC3 CAR-T Cells (CBG166) Therapy for Advanced Hepatocellular Carcinoma

A Phase 1 study testing anti-GPC3 CAR-T in people with Advanced Hepatocellular Carcinoma, run by Zhejiang University at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

A phase I clinical study of 4th generation chimeric antigen receptor T Cells targeting glypican-3 ( CAR-GPC3 T Cells) in patients with advanced hepatocellular carcinoma. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Advanced Hepatocellular Carcinoma
What is being tested?
anti-GPC3 CAR-T
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesChina
Study dates
1 Jul 2024to 31 Oct 2027
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 70 years, male or female;
  • Subjects voluntarily participated in the research and signed the Informed Consent Form (ICF) by themselves or their guardians;
  • Unresectable stage B or C HCC according to the Barcelona Clinic Liver Cancer (BCLC) staging. In case of stage B, the subject must have disease progression following surgery or local treatment, or be unsuitable for surgery or local treatment;
  • Subjects have previously received at least one systemic treatment regimen (including but not limited to targeted therapy, immunotherapy or chemotherapy) with disease progression determined by imaging during or after treatment;
  • Cirrhosis status Child-Pugh score:≤7;
  • Intrahepatic lesions were confirmed by imaging examination (arterial phase enhancement) within 28 days before the start of treatment. According to the RECIST1.1, there was at least one target lesion that could be stably evaluated;
Show all 12Show fewer
  • Expected survival time > 12 weeks;
  • Expression of GPC3 demonstrated by immunohistochemistry (IHC)
  • ECOG Performance Status score: 0 to 1 point;
  • Subjects should have adequate organ function;
  • Subjects should be HBsAg negative. Subjects with positive HBsAg or positive HBcAb are required to have HBV-DNA <2000 IU/ml;
  • The blood pregnancy test of female subjects of childbearing age should be negative within 7 days before cell therapy and not during lactation; Female or male subjects of childbearing age need to take efficient tools or drug contraceptive measures during the whole research process or within one year after CAR-T cell transfusion (What happens later shall prevail);

Who cannot join

  • Subjects with completely resectable liver tumors or who are eligible for liver transplantation;
  • Pregnant or lactating women;
  • Active bacterial or fungal infections within 72 hours prior to gonorrhea clearance (excluding subjects who have no evidence of active infections and antibiotics are not on the prohibited drug list, and continue to use prophylactic antibiotics, antifungal drugs, or antiviral drugs);
  • Patients who had received systemic steroids equivalent to > 15 mg/day prednisone within 2 weeks before apheresis, except those who had recently used or are currently using inhaled steroids;
  • Before apheresis, Hb < 80 g/L, ANC < 1.0 × 109 /L or PLT < 60 × 109 /L;
  • Current clinically significant ascites, which is defined as ascites that are physically positive or require intervention (e.g., puncture or medication) for control (those whose imaging result shows ascites requiring no intervention may be included);
Show all 17Show fewer
  • Imaging results:≥50% of the liver is replaced by tumor or portal vein main tumor thrombus, or tumor thrombus invasion of mesenteric vein / inferior vena cava;
  • Previous or present hepatic encephalopathy;
  • Active brain metastasis;
  • Subjects with a history of organ transplantation or waiting for organ transplantation (including liver transplantation);
  • Any of the following situations exist: Hepatitis B core antibody (HBcAb) positive and hepatitis B virus (HBV) DNA in peripheral blood isperipheral blood hepatitis B virus (HBV) DNA ≥ 2000 IU/mL. Hepatitis C virus (HCV) antibody positive and HCV RNA positive. Human immunodeficiency virus (HIV) antibody positive. Syphilis test positive.
  • Other serious medical conditions that may limit the patient's participation in this trial;
  • Subjects who received anti-tumor therapy within 2 weeks prior to apheresis, or who received any investigational drug or systemic anti-tumor therapy within 28 days (or 5 half-lives of the drug, whichever is more appropriate in the judgment of the investigator) prior to signing the informed consent form;
  • Prior treatment with any therapy that is targeted to GPC3;
  • At the time of signing the informed consent, toxicity caused by previous PD-1/PD-L1 treatment had not returned to grade 1 or baseline levels, except for hair loss and pigmentation;
  • Other uncured malignant tumors in the past 5 years or at the same time, except for cervical cancer in situ and basal cell carcinoma of the skin;
  • According to the investigators' evaluation, patients are unable or unwilling to comply with the requirements of the study protocol.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Qi Zhang, Associate professor contact

13819137113

qi.zhang@zju.edu.cn

China2 sites, 2 recruiting

  • First Affiliated Hospital, Medical College of Zhejiang University

    Hangzhou, Zhejiang, 310003

    Tingbo Liang, MD,PHD, 086-571-87236688, liangtingbo@zju.edu.cn

    Recruiting

  • the First Affiliated Hospital, School of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310009

    Qi Zhang, 13858108798

    Recruiting

Other trials in China

About this study

A phase I clinical study of 4th generation chimeric antigen receptor T Cells targeting glypican-3 ( CAR-GPC3 T Cells) in patients with advanced hepatocellular carcinoma.

Read the detailed description

This is a single-arm, dose-escalation, open, exploratory clinical study to evaluate the safety and tolerability, preliminary efficacy and PK/PD characteristics of GPC3 CAR-T cells in the treatment of advanced hepatocellular carcinoma.

Primary objectives: To evaluated the safety of GPC3 CAR-T cells in patients with advanced hepatocellular carcinoma.

Secondary objectives:To evaluate the preliminary efficacy and PK/PD characteristics of CBG166.

Being tested
anti-GPC3 CAR-T
Keywords
GPC3, Chimeric antigen receptor T cell, Adoptive cell therapy

What participants receive

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

  • anti-GPC3 CAR-TBiological

    Also called CBG166 CAR-T

    All subjects were intravenous administrated with CBG166.

Study groups in NCT06461624
Study groupRoleWhat they receive
GPC3 CAR-T (CBG166)ExperimentalNot described
Receives: Biological: anti-GPC3 CAR-T

What is being measured

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

  1. Dose limiting toxicity (DLT)

    Describe the adverse events of limiting further increases in the dose of CBG166.

    Measured: Within 28 days of CAG166 infusion

  2. Adverse events

    Describe adverse events (AEs) and serious adverse events (SAEs) that are "likely" or "definitely" related to the study treatment that occur at any time of 24 months after treatment.

    Measured: Within 24 months after the treatment

  3. Maximum tolerated dose

    Determine the optimal agent for CBG166 CAR-T at maximum tolerated dose.

    Measured: From enrollment of the first subject to completion of follow-up of the last subject (up to 3 years)

Secondary outcomes (12)

  1. Effectiveness evaluation

    Objective response rate by RECIST 1.1

    Measured: At weeks 4, 8, and 18 and months 3, 4, 6, 9, 12, 15, 18 and 24 after cell infusion

  2. Effectiveness evaluation

    Progression-free survival by RECIST 1.1

    Measured: The efficacy is evaluated at weeks 4, 8, and 18 and months 3, 4, 6, 9, 12, 15, 18 and 24 after cell infusion

  3. Effectiveness evaluation

    Duration of response by RECIST 1.1

    Measured: The efficacy is evaluated at weeks 4, 8, and 18 and months 3, 4, 6, 9, 12, 15, 18 and 24 after cell infusion

  4. Effectiveness evaluation

    Time to response by RECIST 1.1

    Measured: The efficacy is evaluated at weeks 4, 8, and 18 and months 3, 4, 6, 9, 12, 15, 18 and 24 after cell infusion

  5. Effectiveness evaluation

    Disease control time by RECIST 1.1

    Measured: The efficacy is evaluated at weeks 4, 8, and 18 and months 3, 4, 6, 9, 12, 15, 18 and 24 after cell infusion

  6. Pharmacokinetic evaluation

    Detect duration and expansion of CAR-T cells in vivo

    Measured: Within 24 months after the treatment

  7. Pharmacodynamic evaluation

    The copy number of HBV DNA in blood

    Measured: At weeks 4, 8, and 18 and months 3, 4, 6, 9, 12, 15, 18 and 24 after cell infusion

  8. Pharmacodynamic evaluation

    The serum level of IFN-α2

    Measured: At day 1, 4, 7, 15 and 21 and weeks 4, 8, and 18 and months 3, 4, 6, 9, 12, 15, 18 and 24 after cell infusion

  9. Pharmacodynamic evaluation

    The serum level of TGF-β

    Measured: At weeks 4, 8, and 18 and months 3, 4, 6, 9, 12, 15, 18 and 24 after cell infusion

  10. Pharmacodynamic evaluation

    The serum level of soluble AFP

    Measured: At weeks 4, 8, and 18 and months 3, 4, 6, 9, 12, 15, 18 and 24 after cell infusion

  11. Pharmacodynamic evaluation

    The serum level of soluble GPC3

    Measured: At weeks 4, 8, and 18 and months 3, 4, 6, 9, 12, 15, 18 and 24 after cell infusion

  12. Pharmacodynamic evaluation

    The serum levels of cytokine/chemokin

    Measured: At day 1, 4, 7, 15 and 21 and weeks 4, 8, and 18 and months 3, 4, 6, 9, 12, 15, 18 and 24 after cell infusion

Timeline

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

  1. First posted17 Jun 2024
  2. Study start1 Jul 2024
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion31 Oct 2027 (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
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06461624
Sponsor's protocol ID
CRKBY-201
Status last verified
Nov 2024
First submitted
5 Jun 2024
Last updated
6 Nov 2024
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 anti-GPC3 CAR-T in people with Advanced Hepatocellular Carcinoma, run by Zhejiang University 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 12 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 6 Nov 2024. 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?

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?

Contact Qi Zhang, Associate professor (13819137113, qi.zhang@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose limiting toxicity (DLT) (time frame: Within 28 days of CAG166 infusion). The study lists 3 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 NCT06461624.

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 6 Nov 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in