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Hepatocellular CarcinomaNCT03146234

CAR-GPC3 T Cells in Patients With Refractory Hepatocellular Carcinoma

A study testing CAR-GPC3 T cells in people with Hepatocellular Carcinoma, run by RenJi Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is designed to determine the safety and efficacy of CAR-GPC3 T cells in patients with relapsed or refractory hepatocellular carcinoma. Single or multiple doses of GPC3-targeted CAR T cells will be given to subjects with unmet medical needs for which there are no effective therapies known at this time. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Hepatocellular Carcinoma
What is being tested?
CAR-GPC3 T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteChina
Study dates
17 Mar 2017to 18 Oct 2018
Phase
Interventional
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 of 18-70 years;
  • Pathologically confirmed advanced hepatocellular carcinoma (HCC);
  • ≥1 measurable target lesion per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1);
  • Tumor tissue positive for GPC3 expression per immunohistochemical staining (IHC) assay;
  • Estimated survival > 12 weeks;
  • Child-Pugh grade A;
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  • ECOG performance score of 0-1;
  • HBV-DNA < 200 IU/mL if positive for HBsAg or HBcAb. Patients positive for HBsAg shall receive anti-viral treatment per "The guideline of prevention and treatment for chronic hepatitis B: a 2015 update";
  • Have adequate venous access for apheresis or venous blood collection;
  • White blood cells ≥ 2.5 x 109/L, platelet ≥ 60×109/L, haemoglobin ≥ 9.0 g/dL, lymphocyte ≥ 0.4×109/L
  • Serum albumin ≥ 30 g/dL, serum lipase and amylase≤1.5 upper limit of normal (ULN), serum creatinine ≤ 1.5 ULN and endogenous creatinine clearance ≥ 40mL/min, ALT and AST ≤ 5 ULN, Serum total bilirubin ≤ 2.5 ULN, Prothrombin Time is less than 4s longer than normal;
  • Negative serum pregnancy test within 14 days before CAR T infusion, and with willingness to use reliable contraceptive methods to avoid pregnancy until 12 months after CAR T infusions for females of childbearing age; Having undergone sterilization procedure or with willingness to use reliable contraceptive methods to avoid pregnancy for males with female partner of childbearing age during the study;
  • Able to understand and sign the informed consent form

Who cannot join

  • If the patient meets any of the exclusion criteria, the patient must be excluded from the study.
  • Pregnant or lactating female patients;
  • Positive serum tests for HCV, HIV, or syphilis;
  • Presence of HBV/HCV coinfection;
  • Presence of any uncontrollable active infection, such as, but not limited to, active tuberculosis
  • History of systemic administration of steroids (not including inhaled steroids), or other immunosuppressant drugs within 2 weeks before apheresis;
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  • History of allergy to immunotherapy and related drugs, or β-lactam antibiotics, or history of other severe allergy;
  • History or current presence of hepatic encephalopathy;
  • Presence of ascites with clinical significance that is defined as positive focused physical examination for ascites, or ascites that requires treatment intervention (not including any ascites shown on image examinations without the need for clinical intervention);
  • ≥ 50% of normal liver occupied with HCC tumor tissue, or presence of tumor thrombus in the portal vein, or mesenteric vein, or inferior vena based on image analysis;
  • Presence of HCC metastatic lesion in the central nervous system, or presence of other diseases of central nervous system with clinical significance;
  • Presence of heart disease that requires treatment intervention, or poorly controlled hypertension (systolic pressure > 160 mmHg, or diastolic pressure > 100 mmHg);
  • Presence of active auto-immune disease that requires immunosuppressant treatment;
  • History of organ transplantation or currently on the waiting list for organ transplantation, including, but not limited to, liver transplantation;
  • Anti-HCC therapies including, but not limited to, surgical resection, interventional therapy, radiation therapy, chemotherapy, and immunotherapy, within 2 weeks before apheresis;
  • History of receiving anti-PD-1 or anti-PD-L1 monoclonal antibodies, or other immunotherapy;
  • History of other malignancies in the past 5 years, or presence of other active malignancies (not including cervical cancer in situ and basal cell carcinomas);
  • Presence of other serious diseases or conditions, including uncontrolled diabetes (HbA1c > 7% with treatment); severe cardiac dysfunction with LVEF < 45%; myocardial infarction, unstable angina, or unstable arrhythmia in the past 6 months pulmonary embolism; chronic obstructive pulmonary disease; interstitial lung disease; forced expiratory volume in 1 second (FEV1) < 60%, gastric ulcer; history of gastrointestinal bleeding, or confirmed tendency for gastrointestinal bleeding;
  • Determined by the investigator to be lack of compliance for the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Renji Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 20001

Other trials in China

About this study

Official title: Clinical Study of Redirected Autologous T Cells With a GPC3-targeted Chimeric Antigen Receptor in Patients With Refractory Hepatocellular Carcinoma

This study is designed to determine the safety and efficacy of CAR-GPC3 T cells in patients with relapsed or refractory hepatocellular carcinoma. Single or multiple doses of GPC3-targeted CAR T cells will be given to subjects with unmet medical needs for which there are no effective therapies known at this time.

Read the detailed description

A single arm, open-label pilot study is designed to determine the safety, tolerability and engraftment potential of CAR-GPC3 T cells in patients with GPC3-positive hepatocellular carcinoma.

Primary objectives:

Determine the safety, tolerability and cytokinetics of the autologous T cells transduced with the anti- GPC3 lentiviral vector in patients with hepatocellular carcinoma.

Secondary objectives:

Make a preliminary evaluation on the efficacy of CAR-GPC3 T cells in patients with hepatocellular carcinoma by the following parameters:

Objective response rate (ORR); Disease Control Rate (DCR); Time of tumor progression (TTP); Overall survival (OS).

Being tested
CAR-GPC3 T cells
Medical subject headings
Carcinoma, Hepatocellular

What participants receive

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

  • CAR-GPC3 T cellsGenetic

    Also called GPC3 Redirected Autologous Cells

    Self-controlled dose escalation will be applied to the first 3 - 6 subjects enrolled.

    Classical "3+3" dose escalation will be applied to subsequent subjects based on the self-controlled dose escalation study.

Study groups in NCT03146234
Study groupRoleWhat they receive
CAR-GPC3 T cellsExperimentalAutologous T Cells with a GPC3-redirected Chimeric Antigen Receptor. Route of administration: Intravenous injection. Lymphodepletion conditioning regimen: A combination of fludarabine and cyclophosphamide will be administered at Day -6 to Day -3 prior to CAR-GPC3 T cells infusion.
Receives: Genetic: CAR-GPC3 T cells

What is being measured

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

  1. Safety and tolerance

    Study related adverse events are defined as signs above CTCAE Grade 3, laboratory toxicities and clinical events occurred at any time from the first day of infusion to week 24 that are "possibly", "likely", or "definitely" related to the study, including infusion related toxicity and CAR-GPC3 T cells related toxicity. Include but not limited to:

    Fever; Chills; Nausea, vomiting and other gastrointestinal symptoms; Fatigue; Hypotension; Respiratory distress; Tumor lysis syndrome; Cytokine release syndrome; Neutropenia, thrombocytopenia; Liver and kidney dysfunction; Other toxicities.

    Measured: 24 weeks

Secondary outcomes (1)

  1. Engraftment

    Duration of in vivo survival of CAR-GPC3 T cells is defined as "engraftment". The primary engraftment endpoint is the number of DNA vector copies per mL blood of CAR-GPC3 T cells at regular intervals through week 4 following the initial infusion. Q-PCR for CAR-GPC3 vector sequences will be performed until any 2 sequential tests are negative, documented as engraftment and persistence of CAR-GPC3 T cells.

    Measured: 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 posted9 May 2017
  2. Study start17 Mar 2017
  3. Primary completion18 Oct 2018
  4. Study completion18 Oct 2018

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
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03146234
Sponsor's protocol ID
CG1006
Status last verified
Nov 2018
First submitted
24 Apr 2017
Last updated
28 Aug 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing CAR-GPC3 T cells in people with Hepatocellular Carcinoma, run by RenJi 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 13 inclusion and 19 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: finished, as of the sponsor's last update on 28 Aug 2019. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety and tolerance (time frame: 24 weeks). 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 NCT03146234.

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 28 Aug 2019.

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