Carcinoma, HepatocellularPhase 1/2NCT02959151
A Study of Chimeric Antigen Receptor T Cells Combined With Interventional Therapy in Advanced Liver Malignancy
A Phase 1/2 study testing CAR-T cell in people with Carcinoma, Hepatocellular and Pancreatic Cancer Metastatic, run by Shanghai GeneChem Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to collect the date on the safety and potential effectiveness of CART cells combined with interventional therapy in patients with advanced liver malignancy. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Carcinoma, Hepatocellular, Pancreatic Cancer Metastatic, Colorectal Cancer Metastatic
- What is being tested?
- CAR-T cell
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jul 2016to Jul 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
- tumor histological examination confirmed as GPC3/ mesothelin/CEA positive expression;
- persistent cancer after at least one prior standard of care chemotherapy, has no willing for surgery or cannot be suitable for surgery patients
- life expectancy greater than 6 months
- satisfactory organ and bone marrow function as defined by the following: (1) creatinine <1.5mg/dl; (2) cardiac ejection fraction of >55%; (3) hemoglobin>9g/dl, bilirubin 2.0×the institution normal upper limit
- without bleeding disorder or coagulation disorders
- Don't allergy to Radiocontrast agent
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- birth control
- Adequate venous access for apheresis, and no other contraindications for leukapheresis
- Voluntary informed consent is given
Who cannot join
- Pregnant or lactating women
- 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
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- 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)
- Patient with severe acute hypersensitive reaction
- 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
Shanghai Tumor Hospital
Shanghai, Shanghai Municipality, 201206
Wentao Li, doctor, + 86 18017312650, liwentao98@126.com
Xuejun Yu, master, +86 18616108610, yuxuejun@genechem.com.cn
About this study
Official title: A Single-arm Pilot Clinical Study of Chimeric Antigen Receptor T Cells Combined With Interventional Therapy in Advanced Liver Malignancy
The purpose of this study is to collect the date on the safety and potential effectiveness of CART cells combined with interventional therapy in patients with advanced liver malignancy.
Read the detailed description
Designer T cells are prepared by PBMC which from patients or suitable donator by leukapheresis, and then activated and re-engineered to express chimeric antigen receptors (CARs). There are three options for CAR-targets: GPC3 for hepatocellular carcinoma; mesothelin for pancreatic cancer metastatic; CEA for colorectal cancer metastatic. Cells are expanded in culture and returned to the participant by vascular interventional therapy or by intra-tumor injection at the dose of （1.25~4）×107 CAR positive T cells/cm3 tumor bulk. The volume of cell products and the time of cell perfusion process lasted would depend on the ways of cell perfused.
- Being tested
- CAR-T cell
- 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-T cellDrug
Also called chimeric antigen receptor T cells
CAR-T cells are generated by T cells from the patients or a suitable donor transfected by CAR-lentivirus vectors. There are three options for CAR-targets: GPC3 for hepatocellular carcinoma;mesothelin for pancreatic cancer metastatic; CEA for colorectal cancer metastatic.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T for liver cancer | Experimental | A single dose of CART cells will be administered by vascular interventional therapy or by intra-tumor injection with a dose of （1.25~4）×107 CAR positive T cells/cm3 tumor bulk. The volume of cell products and the time of cell perfusion process lasted would depend on the ways of cell perfused. And an interventional radiologist would operate the cell infusion. Receives: Drug: CAR-T cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse event
adverse event is evaluated with CTCAE, version 4.0
Measured: 6 weeks
Secondary outcomes (2)
Number of patients with tumor response
summarize tumor response by overall response rates
Measured: 8 weeks
Detection of transferred T cells in the circulation using quantitative -PCR
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 posted8 Nov 2016 (estimated)
- Study startJul 2016
- Primary completionJan 2018 (estimated)
- Study completionJul 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai GeneChem Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Cancer Hospital, China
- Responsible party
- Sponsor
- Investigators
- Wentao Li, doctor, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959151
- Sponsor's protocol ID
- CAR-T for liver cancer
- Status last verified
- Nov 2016
- First submitted
- 6 Nov 2016
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm Pilot Clinical Study of Chimeric Antigen Receptor T Cells Combined With Interventional Therapy in Advanced Liver Malignancy
- ClinicalTrials.gov ID
- NCT02959151
- Acronym / sponsor ID
- CAR-T for liver cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai GeneChem Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Cancer Hospital, China
- Study start
- Jul 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 8 Nov 2016 (estimated)
- 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.
The purpose of this study is to collect the date on the safety and potential effectiveness of CART cells combined with interventional therapy in patients with advanced liver malignancy.
Detailed description
Designer T cells are prepared by PBMC which from patients or suitable donator by leukapheresis, and then activated and re-engineered to express chimeric antigen receptors (CARs). There are three options for CAR-targets: GPC3 for hepatocellular carcinoma; mesothelin for pancreatic cancer metastatic; CEA for colorectal cancer metastatic. Cells are expanded in culture and returned to the participant by vascular interventional therapy or by intra-tumor injection at the dose of （1.25~4）×107 CAR positive T cells/cm3 tumor bulk. The volume of cell products and the time of cell perfusion process lasted would depend on the ways of cell perfused.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-T for liver cancer | Experimental | Drug: CAR-T cellA single dose of CART cells will be administered by vascular interventional therapy or by intra-tumor injection with a dose of （1.25~4）×107 CAR positive T cells/cm3 tumor bulk. The volume of cell products and the time of cell perfusion process lasted would depend on the ways of cell perfused. And an interventional radiologist would operate the cell infusion. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- tumor histological examination confirmed as GPC3/ mesothelin/CEA positive expression;
- persistent cancer after at least one prior standard of care chemotherapy, has no willing for surgery or cannot be suitable for surgery patients
- life expectancy greater than 6 months
- satisfactory organ and bone marrow function as defined by the following: (1) creatinine <1.5mg/dl; (2) cardiac ejection fraction of >55%; (3) hemoglobin>9g/dl, bilirubin 2.0×the institution normal upper limit
- without bleeding disorder or coagulation disorders
Key exclusion criteria (10 listed)
- Pregnant or lactating women
- 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
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 |
|---|---|---|
| CAR-T cellAlso: chimeric antigen receptor T cellsCAR-T cells are generated by T cells from the patients or a suitable donor transfected by CAR-lentivirus vectors. There are three options for CAR-targets: GPC3 for hepatocellular carcinoma;mesothelin for pancreatic cancer metastatic; CEA for colorectal cancer metastatic. | Drug | CAR-T for liver cancer |
Primary outcome
Number of patients with adverse event
Time frame: 6 weeks
adverse event is evaluated with CTCAE, version 4.0
2 secondary outcomes
Number of patients with tumor response
Time frame: 8 weeks
Detection of transferred T cells in the circulation using quantitative -PCR
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 8 Nov 2016.
- 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.
Wentao Li, doctor principal investigator
Fudan University
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 CAR-T cell in people with Carcinoma, Hepatocellular and Pancreatic Cancer Metastatic, 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 9 inclusion and 10 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 8 Nov 2016. 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 Wentao Li, doctor (+86 18017312650, liwentao98@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse event (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 8 Nov 2016.