Carcinoma, HepatocellularPhase 1/2NCT03130712
A Study of GPC3-targeted T Cells by Intratumor Injection for Advanced HCC (GPC3-CART)
A Phase 1/2 study testing GPC3-CART cells in people with Carcinoma, Hepatocellular, run by Shanghai GeneChem Co., Ltd. at 1 site in China.
Trial summary
In this study, CART cells are targeted to GPC3 by intratumor injected that we hope by this means could improve the local CAR-T cell numbers, meanwhile reduce the potential side effects. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- GPC3-CART cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2017to 31 Mar 2018
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Advanced HCC patients with age between 18 and 69 years old;
- Persistent cancer after at least one prior standard of chemotherapy or surgery, and without high level evidence of second-line treatment;
- The intended intratumoral injection sites of tumor can be showed clear by CT or ultrasound scan, and safe access to without important neuromuscular pass;
- The ECOG score less than 1 points, and the expected survival more than 4 months;
- Recovery from previous treatment: all side effects (except hair loss) were reduced to level 1 or below, according to NCI-CTC AE version 4;
- Pregnancy test (urine beta -HCG) negative (for women of childbearing age);
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- Meet one of the following conditions:
- GPC3 was expressed in more than 15% of tumor cells (immunohistochemical method)
- GPC3 expression in more than 30% of tumor cells (flow cytometry);
- Satisfactory organ and bone marrow function as defined by the following: (1) creatinine <1.5mg/dl; (2) albumin >2; (3) cardiac ejection fraction of >55%; (4) hemoglobin>9g/dl, bilirubin 2.0×the institution normal upper limit;
- Adequate venous access for apheresis;
- Voluntary informed consent.
Who cannot join
- Pregnant or lactating women, urine pregnancy test was positive before transplantation of CAR-T cells 48 hours;
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary;
- Patients in the situation of: (1) 30 days before apheresis is still in the period of other antitumor drug observation; (2) patient dont recuperate from earlier acute adverse influence brought by any treatments accepted before;
- Four weeks before recruit accepted radiation therapy; Previously treatment with any gene therapy products;
- Feasibility assessment during screening demonstrates<30% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation;
- Any serious, uncontrolled diseases (including, but not limit to, unstable angina pectoris, congestive heart failure, grade III or IV cardiac disease, serious arrhythmia, liver and kidney disorders or metabolic diseases, CNS diseases);
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- Patient with severe acute hypersensitive reaction;
- Forced position, can not be adjusted according to requirements;
- Severe heart, lung, liver, kidney function, blood coagulation dysfunction;
- Taking part in other clinical trials;
- Study leader considers not suitable for this tiral.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
302 Military Hospital
Beijing
Lu Yinying, Doctor, 13301256799, luyinying1973@163.com
About this study
Official title: An Open-label, Uncontrolled, Single-arm Pilot Study to Evaluate Intratumor Injection Mediated GPC3-targeted Chimeric Antigen Receptor T Cells in Advanced Hepatocellular Carcinoma
In this study, CART cells are targeted to GPC3 by intratumor injected that we hope by this means could improve the local CAR-T cell numbers, meanwhile reduce the potential side effects.
Read the detailed description
Patients treated with leukapheresis to obtain peripheral blood mononuclear cells, and then PBMC are purified. T cells are activated and then re-engineered to express chimeric antigen receptors (CARs) specific for GPC3. Cells are expanded in culture and returned to the participant by intratumor injection at the dose of(1-10)×106 CAR positive T cells. The cells perfusion process would only last for (1-2) min. GPC-CART cells are injected into each tumor focus only once.
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- GPC3-CART cells
- Keywords
- immunotherapy, GPC3-CART, HCC
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPC3-CART cellsDrug
Intratumol injection as a local drug delivery pathway, so that more T cells gathered at the tumor site, less T cells to migrated to the normal tissue, thereby enhancing the efficacy of anti-tumor, reducing the potential of side effects. And GPC3-CART is a 2nd CAR, with GPC3 as the target protein, 4-1BB as a co- stimulator
| Study group | Role | What they receive |
|---|---|---|
| GPC3-CART cells | Experimental | Not described Receives: Drug: GPC3-CART cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of CAR-T cell infusion mediated by intratumoral injection as measured by number of participants with adverse Events
To determine the safety and regimen limiting toxicity (RLT) of anti-GPC3 CAR-T intratumoral injection for GPC3-expressing HCC.
Measured: 6 weeks
Secondary outcomes (2)
Number of participants with tumor response as measured by RECIST
Measured: 8 weeks]
Serum cytokine levels
Measurement of cytokines as indicators of immune response, including IL-2/IL-6/IL-10/TNF/IL-2R
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start1 Apr 2017
- Primary completion31 Mar 2018 (estimated)
- Study completion31 Mar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai GeneChem Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing 302 Hospital
- Responsible party
- Sponsor
- Investigators
- Lu Yinying, Doctor, Principal investigator, Beijing 302 Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130712
- Sponsor's protocol ID
- 302 GPC3-CART
- Status last verified
- Apr 2017
- First submitted
- 22 Apr 2017
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Uncontrolled, Single-arm Pilot Study to Evaluate Intratumor Injection Mediated GPC3-targeted Chimeric Antigen Receptor T Cells in Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03130712
- Acronym / sponsor ID
- 302 GPC3-CART
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- immunotherapy, GPC3-CART, HCC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shanghai GeneChem Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Beijing 302 Hospital
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Mar 2018 (estimated)
- Study completion
- 31 Mar 2018 (estimated)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, CART cells are targeted to GPC3 by intratumor injected that we hope by this means could improve the local CAR-T cell numbers, meanwhile reduce the potential side effects.
Detailed description
Patients treated with leukapheresis to obtain peripheral blood mononuclear cells, and then PBMC are purified. T cells are activated and then re-engineered to express chimeric antigen receptors (CARs) specific for GPC3. Cells are expanded in culture and returned to the participant by intratumor injection at the dose of(1-10)×106 CAR positive T cells. The cells perfusion process would only last for (1-2) min. GPC-CART cells are injected into each tumor focus only once.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GPC3-CART cells | Experimental | Drug: GPC3-CART cells |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Advanced HCC patients with age between 18 and 69 years old;
- Persistent cancer after at least one prior standard of chemotherapy or surgery, and without high level evidence of second-line treatment;
- The intended intratumoral injection sites of tumor can be showed clear by CT or ultrasound scan, and safe access to without important neuromuscular pass;
- The ECOG score less than 1 points, and the expected survival more than 4 months;
- Recovery from previous treatment: all side effects (except hair loss) were reduced to level 1 or below, according to NCI-CTC AE version 4;
Key exclusion criteria (11 listed)
- Pregnant or lactating women, urine pregnancy test was positive before transplantation of CAR-T cells 48 hours;
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary;
- Patients in the situation of: (1) 30 days before apheresis is still in the period of other antitumor drug observation; (2) patient dont recuperate from earlier acute adverse influence brought by any treatments accepted before;
- Four weeks before recruit accepted radiation therapy; Previously treatment with any gene therapy products;
- Feasibility assessment during screening demonstrates<30% transduction of target lymphocytes, or insufficient expansion (<5-fold) in response to CD3/CD28 costimulation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GPC3-CART cellsIntratumol injection as a local drug delivery pathway, so that more T cells gathered at the tumor site, less T cells to migrated to the normal tissue, thereby enhancing the efficacy of anti-tumor, reducing the potential of side effects. And GPC3-CART is a 2nd CAR, with GPC3 as the target protein, 4-1BB as a co- stimulator | Drug | GPC3-CART cells |
Primary outcome
Safety of CAR-T cell infusion mediated by intratumoral injection as measured by number of participants with adverse Events
Time frame: 6 weeks
To determine the safety and regimen limiting toxicity (RLT) of anti-GPC3 CAR-T intratumoral injection for GPC3-expressing HCC.
2 secondary outcomes
Number of participants with tumor response as measured by RECIST
Time frame: 8 weeks]
Serum cytokine levels
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lu Yinying, Doctor principal investigator
Beijing 302 Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GPC3-CART cells in people with Carcinoma, Hepatocellular, run by Shanghai GeneChem Co., Ltd. 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 11 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: status not confirmed, as of the sponsor's last update on 26 Apr 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lu Yinying, Doctor (13301256799, luyinying1973@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of CAR-T cell infusion mediated by intratumoral injection as measured by number of participants with adverse Events (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Apr 2017; AzTrials last refreshed its copy on 6 Nov 2026.