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Hepatocellular CarcinomaPhase 1NCT02395250

Anti-GPC3 CAR T for Treating Patients With Advanced HCC

A Phase 1 study testing anti-GPC3 CAR T 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

The purpose of this study is to determine whether autologous T cells bearing chimeric antigen receptor that can specifically recognize glypican-3 (GPC3) is safe and effective for patients with relapsed or refractory hepatocellular carcinoma (HCC). 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?
anti-GPC3 CAR T
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
1 siteChina
Study dates
Mar 2015to Nov 2018
Phase
Phase 1
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

  • Shanghai Cancer Institute

    Xuhui, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: Autologous T Cells Redirected to GPC3 for Treating Patients With Advanced HCC

The purpose of this study is to determine whether autologous T cells bearing chimeric antigen receptor that can specifically recognize glypican-3 (GPC3) is safe and effective for patients with relapsed or refractory hepatocellular carcinoma (HCC).

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

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 CAR T cells redirected to Glypican-3 in cancer cells

Study groups in NCT02395250
Study groupRoleWhat they receive
anti-GPC3 CAR TExperimentalNot 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. Adverse events attributed to the administration of the anti-GPC3 CAR 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 posted23 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionJun 2016
  4. Study completionNov 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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02395250
Sponsor's protocol ID
RJ-20150313
Status last verified
Nov 2018
First submitted
17 Mar 2015
Last updated
28 Aug 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Shi Y, Shi D, Chi J, Cui D, Tang X, Lin Y, Wang S, Li Z, Jin H, Zhai B. Combined local therapy and CAR-GPC3 T-cell therapy in advanced hepatocellular carcinoma: a proof-of-concept treatment strategy. Cancer Commun (Lond). 2023 Sep;43(9):1064-1068. doi: 10.1002/cac2.12472. Epub 2023 Jul 21. No abstract available.

    PubMed 37478283

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing anti-GPC3 CAR T 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.

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?

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?

Adverse events attributed to the administration of the anti-GPC3 CAR T cells (time frame: 2 years). 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 NCT02395250, which also lists 1 linked publication.

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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