AzTrials
AzTrials

Advanced Hepatocellular CarcinomaNCT05620706

Study of GPC-3 CAR-T Cells in Treating With Hepatocellular Carcinoma

A study testing GPC3 CAR-T cells in people with Advanced Hepatocellular Carcinoma, run by Shenzhen University General Hospital at 1 site 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

Hepatocellular carcinoma is a highly heterogeneous disease. Treatment strategies for advanced hepatocellular carcinoma are limited. Phosphatidylinositol proteoglycan 3 (GPC3) is a heparan sulfate glycoprotein (HSPG) on the surface of the cell membrane. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Advanced Hepatocellular Carcinoma
What is being tested?
GPC3 CAR-T cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Nov 2022to 31 Oct 2028
Phase
Interventional
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 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 40~70 years old;
  • Patients with advanced hepatocellular carcinoma (HCC) diagnosed by histopathology or cytology, who are not suitable for surgery or local treatment (including ablation therapy, interventional therapy and radiotherapy), and who have experienced progress or intolerance after receiving standard treatment in the past;
  • Patients who have been terminated for more than 28 days due to previous ineffective PD-1 monoclonal antibody treatment;
  • At least one target lesion that can be evaluated stably according to RECIST 1.1 standard is defined as: the longest diameter of non lymph node lesions ≥ 10mm, or the short diameter of lymph node lesions ≥ 15mm; Intrahepatic lesions require enhanced imaging in arterial phase;
  • Tumor tissue samples were positive for GPC3 by immunohistochemistry (IHC);
  • Grade C according to Barcelona liver cancer grading standard (BCLC) or Grade B which is not suitable for local treatment/progression of local treatment;
Show all 21Show fewer
  • Estimated survival time > 12 weeks;
  • Cirrhotic state Child Pugh score Grade A
  • ECOG physical status score 0~1;
  • If the patient is HBsAg positive or HBcAb positive, HBV-DNA<200IU/ml. HBsAg positive patients must receive antiviral treatment according to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015);
  • Single vein access;
  • Blood routine test: WBC ≥ 2.5 × 109/L， PLT≥60 × 109/L， Hb≥9.0 g/dL，LY≥0.4 × 109/L；
  • Blood biochemistry: serum Alb ≥ 30 g/L, serum lipase and amylase ≤ 1.5 ULN, serum creatinine ≤ 1.5 ULN and endogenous creatinine clearance rate ≥ 40mL/min, ALT ≤ 5ULN, AST ≤ 5ULN, total bilirubin ≤ 2.5ULN, prothrombin time extension ≤ 4s;
  • The women of childbearing age must carry out serum pregnancy test within the screening period and 14 days before starting the study medication, and the result is negative. They are willing to use reliable methods of contraception during the test period (within 12 months (M12) after cell infusion); For male subjects whose partners are women of childbearing age, they should have undergone sterilization or agree to use reliable methods of contraception during the trial
  • Be able to understand and sign the informed consent form
  • HBsAg positive patients must receive antiviral treatment according to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015);
  • 11. Single vein access;
  • 12. Blood routine test: WBC ≥ 2.5 × 109/L， PLT≥60 × 109/L， Hb≥9.0 g/dL，LY≥0.4 × 109/L；
  • 13. Blood biochemistry: serum Alb ≥ 30 g/L, serum lipase and amylase ≤ 1.5 ULN, serum creatinine ≤ 1.5 ULN and endogenous creatinine clearance rate ≥ 40mL/min, ALT ≤ 5ULN, AST ≤ 5ULN, total bilirubin ≤ 2.5ULN, prothrombin time extension ≤ 4s;
  • 14. The women of childbearing age must carry out serum pregnancy test within the screening period and 14 days before starting the study medication, and the result is negative. They are willing to use reliable methods of contraception during the test period (within 12 months (M12) after cell infusion); For male subjects whose partners are women of childbearing age, they should have undergone sterilization or agree to use reliable methods of contraception during the trial
  • 15. Be able to understand and sign the informed consent form

Who cannot join

  • Pregnant or lactating women;
  • HCV-RNA, HIV antibody or syphilis antibody are positive;
  • Any uncontrollable active infection, including but not limited to active tuberculosis;
  • Have received systemic steroids equivalent to>15 mg prednisone within 2 weeks before single collection, except inhaled steroids;
  • Allergies to immunotherapy and related drugs, previous severe allergies β- Allergy to lactam antibiotics;
  • Previous or current hepatic encephalopathy;
Show all 18Show fewer
  • At present, there is ascites with clinical significance, which is defined as: ascites with positive signs on physical examination or ascites that need to be controlled by intervention (such as puncture or drug therapy) (only those with ascites shown on imaging without intervention can be included);
  • Imaging examination results: the proportion of liver being replaced by tumor ≥ 50%, or portal trunk tumor thrombus, or tumor thrombus invading mesenteric vein/inferior vena cava;
  • Central nervous system metastasis and diseases of central nervous system with clinical significance;
  • At present, there is a heart disease that needs treatment or hypertension that is judged by the researcher to be poorly controlled (systolic blood pressure>160mmHg or diastolic blood pressure>100mmHg);
  • Patients with known active autoimmune diseases need to be treated with immunosuppressants including biological agents;
  • Patients with a history of organ transplantation or waiting for organ transplantation (including liver transplantation);
  • Have received treatment for the study disease within 2 weeks before single collection, including but not limited to surgical treatment, interventional treatment, radiotherapy, chemotherapy and immunotherapy;
  • Received targeted GPC3 treatment, TCR-T treatment and CAR-T treatment in the past month;
  • Being treated with anti PD-1/PD-L1 monoclonal antibody in the past 28 days;
  • Other incurable malignant tumors in the past 5 years or at the same time, excluding cervical carcinoma in situ and skin basal cell carcinoma;
  • Other serious diseases that may restrict the subjects from participating in this trial (such as diabetes under poor control (HbA1c>7% after treatment), severe cardiac insufficiency (LVEF<45%), myocardial infarction or unstable arrhythmia or unstable angina pectoris in the last 6 months, pulmonary embolism, chronic obstructive pulmonary disease, interstitial lung disease Pulmonary function test FEV1 accounts for less than 60% of the estimated value, gastric ulcer, history of gastrointestinal bleeding disease or clear gastrointestinal bleeding tendency);
  • The investigator assessed that the patient was unable or unwilling to comply with the requirements of the study protocol.

Trial locations and contacts

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

Li Yu, Dr contact

+8675521839178

liyu@vip.163.com

China1 site, 1 recruiting

  • Li Yu

    Shenzhen, Guangdong, 518000

    Li Yu, +8675521839178, liyu_gcp@163.com

    Recruiting

Other trials in China

About this study

Official title: Study of GPC-3 CAR-T Cells in Advanced Hepatocellular Carcinoma

Hepatocellular carcinoma is a highly heterogeneous disease. Treatment strategies for advanced hepatocellular carcinoma are limited. Phosphatidylinositol proteoglycan 3 (GPC3) is a heparan sulfate glycoprotein (HSPG) on the surface of the cell membrane. It is highly expressed in liver cancer tissues, but hardly expressed in normal liver tissues. It is an ideal target for tumor treatment. Investigators aimed to test the safety and efficacy of GPC3 CAR-T cells in patients with advanced hepatocellular carcinoma.

Read the detailed description

Hepatocellular carcinoma is a highly heterogeneous disease. Treatment strategies for advanced hepatocellular carcinoma are limited. Resulting in a poor prognosis. Phosphatidylinositol proteoglycan 3 (GPC3) is a heparan sulfate glycoprotein (HSPG) on the surface of the cell membrane. It is highly expressed in liver cancer tissues, but hardly expressed in normal liver tissues. It is an ideal target for tumor treatment. Investigators aimed to test the safety and efficacy of GPC3 CAR-T cells in patients with advanced hepatocellular carcinoma.

Being tested
GPC3 CAR-T cells

What participants receive

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

  • GPC3 CAR-T cellsBiological

    patients treated with GPC3 CAR-T cells

Study groups in NCT05620706
Study groupRoleWhat they receive
Treatment groupExperimentalGCP3 CAR-T cells
Receives: Biological: GPC3 CAR-T cells

What is being measured

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

  1. AE/SAE

    adverse event/sever adverse event

    Measured: from cell infusion to 30 days after infusion

Secondary outcomes (1)

  1. ORR

    overall response rate

    Measured: From admission to the end of follow up, up to 2 years.

Timeline

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

  1. First posted17 Nov 2022
  2. Study start1 Nov 2022
  3. Primary completion31 Oct 2025 (estimated)
  4. Study completion31 Oct 2028 (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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05620706
Sponsor's protocol ID
HEM-ONCO-023
Status last verified
Nov 2022
First submitted
11 Nov 2022
Last updated
22 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing GPC3 CAR-T cells in people with Advanced Hepatocellular Carcinoma, run by Shenzhen University General Hospital 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 21 inclusion and 18 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 22 Nov 2022. 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.

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 Li Yu, Dr (+8675521839178, liyu@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AE/SAE (time frame: from cell infusion to 30 days after infusion). 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 NCT05620706.

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 22 Nov 2022.

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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in