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GPC3 Positive Hepatocellular CarcinomaPhase 1/2NCT02723942

CAR-T Cell Immunotherapy for HCC Targeting GPC3

A Phase 1/2 study testing CAR-T cell immunotherapy in people with GPC3 Positive Hepatocellular Carcinoma and CAR-T Cell Immunotherapy, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to preliminarily evaluate the safety and efficacy of CAR-T cell immunotherapy for GPC3 positive hepatocellular carcinoma. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
CAR-T cell immunotherapy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
Jun 2015to 15 Aug 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • Age:18-70 years.
  • Gender:both.
  • GPC3 high expression hepatocellular carcinoma patients.
  • Non diffuse hepatocellular carcinoma，no extrahepatic metastasis or portal vein vascular invasion.
  • Degree of liver cirrhosis：class A or class B 7 according to Child-puge grading standard.
  • Routine blood test：white blood cell count（WBC)>=3×10^9/L, Lymphocyte percentage>=15%, hemoglobinHbo（Hb）>=90g/L, prothrombin time（PT） prolongation<=50% normal value, Cluster of differentiation 3(CD3) positive T cell count>=0.8×10^9/L.
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  • Liver and Pancreatic function：Alanine aminotransferase/Aspartate transaminase(ALT/AST)<=5 times of the normal value, total bilirubin(TBiL)<=3.0mg/dL, albumin(ALB)>=35g/L, prothrombin time(PT):International Normalized Ratio(INR)<=1.7 or prothrombin time(PT) prolongation<=4s, Serum lipase<=1.5 times of the normal value, Serum amylase<=1.5 times of the normal value.
  • Renal function：Serum creatinine(SCr)<=221μmol/L(2.5mg/L).
  • Karnofsky Performance Status(KPS)>=60；Expected survival time>=12 weeks.
  • Peripheral venous access ；no contraindication of lymphocyte separation.
  • No other serious complications.
  • Voluntarily signed informed consent.

Who cannot join

  • Pregnant and lactating women.
  • Lymphocyte separation or peripheral venous access cannot be performed in patients .
  • Patients in the active stage of infection or with coagulation disorders.
  • Patients with a previous history of hepatic coma.
  • Patients with severe gastrointestinal ulcers or gastrointestinal bleeding.
  • Patients with organ transplantation or waiting for organ transplantation.
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  • Patients with anticoagulant therapy.
  • Patients with antiplatelet therapy.
  • Serum sodium(Na)<125 mmol/L.
  • Serum potassium(K)<3.5 mmol/L(except patients up to the standards after the use of supplements).
  • Patients with organ failure：
  • cardiac function：level three or above according to New York Heart Association (NYHA) criteria.
  • liver function:class C or above according to Child-puge grading standard.
  • renal function:Chronic kidney disease(CKD) phase 4 or more; renal insufficiency phase Ⅲ or more.
  • pulmonary function：severe respiratory failure symptoms, involving other organs.
  • Brain function:central nervous system abnormalities or disturbance of consciousness.
  • Patients with non controlled infectious diseases,for example,HIV positive, syphilis, hepatitis A, hepatitis B, hepatitis C, hepatitis E virus (HEV) positive etc.
  • Patients used corticosteroids or other immunosuppressive agents in the past 4 weeks.
  • Patients with autoimmune disease.
  • Patients with previous history of gene therapy.
  • The actual transfection rate of T cells was lower than 30% or the proliferation was less than 5 times after costimulation.
  • Patients participated in other drug trials in the past 4 weeks.
  • Patients received radiation treatment in the past 4 weeks.
  • Patients do not meet the criteria above.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Central laboratory in Fuda cancer hospital

    Guangzhou, Guangdong, 510000

Other trials in China

About this study

Official title: Chimeric Antigen Receptor-Modified T Cell (CAR-T) Immunotherapy for Hepatocellular Carcinoma (HCC) Targeting Glypican-3 (GPC3)

The purpose of this study is to preliminarily evaluate the safety and efficacy of CAR-T cell immunotherapy for GPC3 positive hepatocellular carcinoma.

Read the detailed description

Chimeric antigen receptor (CAR) is a recombinant receptor with both antigen-binding and T cell activating functions. Chimeric antigen receptor T cell Immunotherapy has more advantages compared with conventional immunotherapy, especially in dealing with patients of hematologic malignancies and solid malignant tumors.This study design a novel specific Chimeric antigen receptor targeting glypican-3(GPC3) antigen.After CAR-T cell infusion,At periodic intervals, the investigators will evaluate clinical symptoms Improved conditions of this disease.Through this study,the investigators will evaluate the safety and efficacy of CAR-T cell immunotherapy in treating with GPC3 positive malignant glioma patients.

Being tested
CAR-T cell immunotherapy
Keywords
glypican-3(GPC3), chimeric antigen receptor-modified T cell(CAR-T), hepatocellular carcinoma(HCC)
Medical subject headings
Simpson-Golabi-Behmel syndrome, Carcinoma, Hepatocellular

What participants receive

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

  • CAR-T cell immunotherapyBiological

    This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GPC3 antigen.

Study groups in NCT02723942
Study groupRoleWhat they receive
CAR-T cell immunotherapyExperimentalEnrolled patients will receive CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GPC3 antigen by infusion.
Receives: Biological: CAR-T cell immunotherapy
no interventionNo interventionno intervention

What is being measured

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

  1. Radiological assessment

    Radiological assessment of the therapeutic effect by systemic or local computed Tomography(CT) or positron emission tomography scan.

    Measured: 3 months

Secondary outcomes (3)

  1. The safety of CAR-T cell immunotherapy (adverse events)

    After CAR-T cell infusion,we will observe the potential adverse events related to the T-cell infusion such as high fever,jaundice, kidney failure and so on.

    Measured: 4 weeks

  2. Peripheral blood tumor markers

    tested regularly to reflect the role of the Chimeric Antigen Receptor-Modified T Cell in the removal of residual tumor cells.

    Measured: 3 months

  3. CAR-T cell testing

    The level of CAR-T cells will be tested regularly by Real-time Quantitative Polymerase Chain Reaction Detecting System(qPCR) or Flow cytometry to evaluate the proliferation in vivo and long-term survival.

    Measured: 3 months

Timeline

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

  1. First posted31 Mar 2016 (estimated)
  2. Study startJun 2015
  3. Primary completion15 Aug 2016
  4. Study completion15 Aug 2016

Why it stopped: Project terminated due to revision of local regulations

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02723942
Sponsor's protocol ID
CAR-T for GPC3+ HCC
Status last verified
Jul 2020
First submitted
20 Mar 2016
Last updated
16 Jul 2020
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CAR-T cell immunotherapy in people with GPC3 Positive Hepatocellular Carcinoma and CAR-T Cell Immunotherapy, run by Fuda Cancer Hospital, Guangzhou 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 12 inclusion and 24 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: withdrawn, as of the sponsor's last update on 16 Jul 2020. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Radiological assessment (time frame: 3 months). 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 NCT02723942.

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 16 Jul 2020.

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