Hepatocellular CarcinomaPhase 1/2NCT03084380
Anti-GPC3 CAR-T for Treating GPC3-positive Advanced Hepatocellular Carcinoma (HCC)
A Phase 1/2 study testing Retroviral vector-transduced autologous T cells to express anti-GPC3 CARs, Fludarabine and Cyclophosphamide in people with Hepatocellular Carcinoma, run by Xinqiao Hospital of Chongqing at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the safety and efficacy of anti-GPC3 scFv-41BB-CD3ζ-tEGFR chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating patients with GPC3-positive advanced 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?
- Retroviral vector-transduced autologous T cells to express anti-GPC3 CARs, Fludarabine and Cyclophosphamide
- 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
- 1 Jun 2017to 31 May 2020
- 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
- Expected to survive more than 3 months
- PS 0-2
- Immunohistochemistry was confirmed to be GPC3 positive hepatocellular carcinoma
- Patients with no ability to receive TACE combined with sorafenib
- WBC>3.5×1e+9/L,Hb>90g/L,PLT>75×1e+9/L
- HBV DNA copy number less than 100/ml
- ALT≤5ULN, AST≤5ULN, TB≤1.5ULN, ALB≥35g/L
- Understand this test and have signed informed consent
Who cannot join
- Hepatic encephalopathy, autoimmune diseases, or any uncontrolled active disease that hinders participation in the trial
- Decompensated liver cirrhosis, liver function Child-pugh C grade
- Portal vein tumor thrombus, arterial portal fistula, hepatic arteriovenous
- Long-term use of immunosuppressive agents after organ transplantation
- Screening indicated that the target cell transfection rate was less than 30%
- Invasive pulmonary embolism, deep venous thrombosis, or other major arterial / venous thromboembolic events occurred 30 days or 30 days prior to randomization
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- Subjects had an active or uncontrollable infection requiring systemic therapy 14 days or 14 days prior to randomization
- Pregnant or lactating subjects
- In the opinion of the investigator, the presence of a medical history or a history of mental state may increase the number of subjects associated with the risk factors associated with the study or study drug administration
- Subjects who have signed a written consent or who are in compliance with the study procedure; or who are unwilling or unable to comply with the study
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Oncology, Xinqiao Hospital
Chongqing, Chongqing Municipality, 400037
About this study
Official title: Phase I Trial of Anti-GPC3 Chimeric T Cells for Subjects With GPC3-Positive Advanced Hepatocellular Carcinoma
The goal of this clinical trial is to evaluate the safety and efficacy of anti-GPC3 scFv-41BB-CD3ζ-tEGFR chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating patients with GPC3-positive advanced hepatocellular carcinoma (HCC).
Read the detailed description
Primary Objectives:
- To evaluate the safety of intravenous administration of the anti-GPC3 CAR-T cells in patients with HCC or lung squamous cell carcinoma
- To access the safety of anti-GPC3 CAR-T cells in HCC patients through catheter injection
Secondary Objectives:
- To evaluate the efficacy of anti-GPC3 CAR-T cells in patients with advanced HCC or lung squamous cell carcinoma
- To monitor the serum cytokine and expression level of tumor markers such as AFP, CEA and GPC3
- To assess the persistence in peripheral blood and intratumoral infiltration of anti-GPC3 CAR-T cells
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Retroviral vector-transduced autologous T cells to express anti-GPC3 CARs, Fludarabine, Cyclophosphamide
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retroviral vector-transduced autologous T cells to express anti-GPC3 CARsBiological
transcatheter arterial chemoembolization + CAR-T infusion
FludarabineDrug
Fludarabine will be administered at dose of 25mg/m2/d
CyclophosphamideDrug
Cyclophosphamide will be administered at dose of 40mg/kg for 1 day and then fludarabine will be given for the next 5 days and then the T cells will be administered
| Study group | Role | What they receive |
|---|---|---|
| anti-GPC3 CAR-T | Experimental | Transcatheter arterial chemoembolization (TACE) combine with GPC3-CART infusion Receives: Biological: Retroviral vector-transduced autologous T cells to express anti-GPC3 CARs; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Measured: 4 weeks
Secondary outcomes (2)
Efficacy: Overall complete remission rate defined by the standard response criteria
Overall complete remission rate defined by the standard response criteria
Measured: 8 weeks
Persistence: Duration of CAR-positive T cells in circulation
Duration of CAR-positive T cells in circulation
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2017
- Study start1 Jun 2017 (estimated)
- Primary completion31 May 2019 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies 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
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingzhu Jia, M.D., Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084380
- Sponsor's protocol ID
- GPC3CAR
- Status last verified
- Mar 2017
- First submitted
- 5 Mar 2017
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Anti-GPC3 Chimeric T Cells for Subjects With GPC3-Positive Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT03084380
- Acronym / sponsor ID
- GPC3CAR
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- 1 Jun 2017 (estimated)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 20 Mar 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.
The goal of this clinical trial is to evaluate the safety and efficacy of anti-GPC3 scFv-41BB-CD3ζ-tEGFR chimeric antigen receptor (CAR)-modified T (CAR-T) cells in treating patients with GPC3-positive advanced hepatocellular carcinoma (HCC).
Detailed description
Primary Objectives:
- To evaluate the safety of intravenous administration of the anti-GPC3 CAR-T cells in patients with HCC or lung squamous cell carcinoma
- To access the safety of anti-GPC3 CAR-T cells in HCC patients through catheter injection
Secondary Objectives:
- To evaluate the efficacy of anti-GPC3 CAR-T cells in patients with advanced HCC or lung squamous cell carcinoma
- To monitor the serum cytokine and expression level of tumor markers such as AFP, CEA and GPC3
- To assess the persistence in peripheral blood and intratumoral infiltration of anti-GPC3 CAR-T cells
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-GPC3 CAR-T | Experimental | Biological: Retroviral vector-transduced autologous T cells to express anti-GPC3 CARs, Drug: Fludarabine, Drug: CyclophosphamideTranscatheter arterial chemoembolization (TACE) combine with GPC3-CART infusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Expected to survive more than 3 months
- PS 0-2
- Immunohistochemistry was confirmed to be GPC3 positive hepatocellular carcinoma
- Patients with no ability to receive TACE combined with sorafenib
- WBC>3.5×1e+9/L,Hb>90g/L,PLT>75×1e+9/L
Key exclusion criteria (10 listed)
- Hepatic encephalopathy, autoimmune diseases, or any uncontrolled active disease that hinders participation in the trial
- Decompensated liver cirrhosis, liver function Child-pugh C grade
- Portal vein tumor thrombus, arterial portal fistula, hepatic arteriovenous
- Long-term use of immunosuppressive agents after organ transplantation
- Screening indicated that the target cell transfection rate was less than 30%
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 |
|---|---|---|
| Retroviral vector-transduced autologous T cells to express anti-GPC3 CARstranscatheter arterial chemoembolization + CAR-T infusion | Biological | anti-GPC3 CAR-T |
| FludarabineFludarabine will be administered at dose of 25mg/m2/d | Drug | anti-GPC3 CAR-T |
| CyclophosphamideCyclophosphamide will be administered at dose of 40mg/kg for 1 day and then fludarabine will be given for the next 5 days and then the T cells will be administered | Drug | anti-GPC3 CAR-T |
Primary outcome
Safety: Measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Time frame: 4 weeks
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
2 secondary outcomes
Efficacy: Overall complete remission rate defined by the standard response criteria
Time frame: 8 weeks
Persistence: Duration of CAR-positive T cells in circulation
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Retroviral vector-transduced autologous T cells to express anti-GPC3 CARs, Fludarabine and Cyclophosphamide in people with Hepatocellular Carcinoma, run by Xinqiao Hospital of Chongqing 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 8 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 20 Mar 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?
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: Measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 (time frame: 4 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 20 Mar 2017.