Hepatocellular CarcinomaPhase 1NCT04506983
GPC3-CAR-T Cells for the Hepatocellular Carcinoma
A Phase 1 study testing GPC3-CAR-T cells in people with Hepatocellular Carcinoma, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of GPC3-CAR-T cells in patients with hepatocellular carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- GPC3-CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2022to 10 Oct 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≧18years, gender unlimited.
- Failure or intolerance after at least first-line treatment.
- GPC3 positive(IHC)
- Patients must have at least one target lesion available for evaluation.
- BCLC B or C.
- Child-Pugh grade A or B
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- ECOG is 0 or 1 (one week before enrollment.)
- Estimated life expectancy ≥ 3 months.
- Functioning of major organs are normal.
- Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside.
- Patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures.
Who cannot join
- There are uncontrollable active infections that need systemic treatment.
- HIV antibody is positive or syphilis antibody is positive.
- Pregnant or lactating women.
- hepatic encephalopathy.
- patients with organ failure:
- Heart: NYHA heart function grade IV;
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- Liver: Grade C that achieves Child-Turcotte liver function grading;
- Kidney: kidney failure and uremia;
- Lung: symptoms of respiratory failure;
- Brain: a person with a disability.
- It is undergoing systemic hormones therapy.
- Impact results show that over 50% of the liver is occupied by tumor .
- Patients who are still in the observation stage of other antitumor drugs 30 days before blood collection.
- Patients were received other gene therapy products, or are participating in other clinical trials within 4 weeks prior to cell infusion.
- Abnormal thyroid function ≧Level 3.
- Active autoimmune diseases require systemic treatment during the first two years of screening.
- Patients have mental illness or history of drug abuse.
- Patients are participating in other clinical studies.
- The researchers found that it was unsuitable for the recipients to be enrolled.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Phase I Efficacy and Safety Clinical Study of GPC3-CAR-T Cells in Hepatocellular Carcinoma Patients
This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of GPC3-CAR-T cells in patients with hepatocellular carcinoma.
Read the detailed description
GPC3-CAR-T cells is a novel CAR-T cells which designed for the cell membrane protein Glypican-3. Patients with hepatocellular carcinoma will be enrolled, and GPC3-CAR-T cells will be intravenously infused with a escalated dose of 1×106, 3×106, 10×106 GPC3-CAR-T cells. Tumor markers and GPC3-CAR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28). The aim of this clinical trial is to evaluate the safety and efficacy of GPC3-CAR-T cells therapy in patients with hepatocellular carcinoma. The primary endpoint is the safety of CAR-T cells including the effect ratio of CRS and ICANS, ORR. The secondary endpoint is the CAR-T ratio and CAR gene copied number in PB, PFS, OS and DOR.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- GPC3-CAR-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.
GPC3-CAR-T cellsBiological
Patients with hepatocellular carcinoma will be enrolled, and GPC3-CAR-T cells will be intravenously infused with a escalated dose of 1×106 /3×106/10×106GPC3-CAR-T cells.
| Study group | Role | What they receive |
|---|---|---|
| GPC3-CAR-T cells | Experimental | Patients with hepatocellular carcinoma will be enrolled, and GPC3-CAR-T cells will be intravenously infused with a escalated dose of 1×106 /3×106/10×106GPC3-CAR-T cells. Tumor markers and GPC3-CAR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14,day 21, day 28). Receives: Biological: GPC3-CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of adverse events
Percentage of participants with adverse events.
Measured: 12months
Secondary outcomes (2)
Objective Remission Rate(ORR)
The percentage of participants who achieved complete remission (CR) and partial remission over all participants.
Measured: 12months
Proliferation ratio of CAR-T cells
Measured: 12months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start10 Jun 2022 (estimated)
- Primary completion10 Jun 2023 (estimated)
- Study completion10 Oct 2023 (estimated)
Why it stopped: Adjust the plan
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.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Immunotech (Beijing) Biotechnology Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Gong Li, M.A., Study director, Beijing Tsinghua Changgeng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506983
- Sponsor's protocol ID
- HXYT-009
- Status last verified
- Jan 2022
- First submitted
- 6 Aug 2020
- Last updated
- 14 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Phase I Efficacy and Safety Clinical Study of GPC3-CAR-T Cells in Hepatocellular Carcinoma Patients
- ClinicalTrials.gov ID
- NCT04506983
- Acronym / sponsor ID
- HXYT-009
- Conditions
- Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Adjust the plan
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Collaborators
- China Immunotech (Beijing) Biotechnology Co., Ltd.
- Study start
- 10 Jun 2022 (estimated)
- Primary completion
- 10 Jun 2023 (estimated)
- Study completion
- 10 Oct 2023 (estimated)
- First posted
- 10 Aug 2020 (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.
This is a single center, single arm, open-label, phase I study to evaluate the safety and efficacy of GPC3-CAR-T cells in patients with hepatocellular carcinoma.
Detailed description
GPC3-CAR-T cells is a novel CAR-T cells which designed for the cell membrane protein Glypican-3. Patients with hepatocellular carcinoma will be enrolled, and GPC3-CAR-T cells will be intravenously infused with a escalated dose of 1×106, 3×106, 10×106 GPC3-CAR-T cells. Tumor markers and GPC3-CAR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28). The aim of this clinical trial is to evaluate the safety and efficacy of GPC3-CAR-T cells therapy in patients with hepatocellular carcinoma. The primary endpoint is the safety of CAR-T cells including the effect ratio of CRS and ICANS, ORR. The secondary endpoint is the CAR-T ratio and CAR gene copied number in PB, PFS, OS and DOR.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GPC3-CAR-T cells | Experimental | Biological: GPC3-CAR-T cellsPatients with hepatocellular carcinoma will be enrolled, and GPC3-CAR-T cells will be intravenously infused with a escalated dose of 1×106 /3×106/10×106GPC3-CAR-T cells. Tumor markers and GPC3-CAR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14,day 21, day 28). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≧18years, gender unlimited.
- Failure or intolerance after at least first-line treatment.
- GPC3 positive(IHC)
- Patients must have at least one target lesion available for evaluation.
- BCLC B or C.
Key exclusion criteria (19 listed)
- There are uncontrollable active infections that need systemic treatment.
- HIV antibody is positive or syphilis antibody is positive.
- Pregnant or lactating women.
- hepatic encephalopathy.
- patients with organ failure:
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-CAR-T cellsPatients with hepatocellular carcinoma will be enrolled, and GPC3-CAR-T cells will be intravenously infused with a escalated dose of 1×106 /3×106/10×106GPC3-CAR-T cells. | Biological | GPC3-CAR-T cells |
Primary outcome
Percentage of adverse events
Time frame: 12months
Percentage of participants with adverse events.
2 secondary outcomes
Objective Remission Rate(ORR)
Time frame: 12months
Proliferation ratio of CAR-T cells
Time frame: 12months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2022.
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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.
Gong Li, M.A. study director
Beijing Tsinghua Changgeng 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 study testing GPC3-CAR-T cells in people with Hepatocellular Carcinoma, run by Beijing Tsinghua Chang Gung 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 11 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: paused, as of the sponsor's last update on 14 Feb 2022. 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?
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?
Percentage of adverse events (time frame: 12months). 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 14 Feb 2022.