Advanced Hepatocellular CarcinomaPhase 1NCT05352542
GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma
A Phase 1 study testing GPC3 Targeting CART Cells in people with Advanced Hepatocellular Carcinoma, run by jianming xu at 2 sites in China.
Trial summary
A Phase I Clinical Trial for Evaluating the Safety, Tolerance and Efficacy of GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Hepatocellular Carcinoma
- What is being tested?
- GPC3 Targeting CART Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesChina
- Study dates
- 19 May 2022to 31 Jul 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent;
- Age 18-75 years;
- Patients diagnosed as advanced hepatocellular carcinoma (HCC) histopathologically or cytologically; Progression or intolerance after previous standard systemic therapy;
- GPC3 is detected positive by immunohistochemistry (IHC);
- Child-Pugh score ≤ 7;
- At least one assessable tumor lesion;
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- ECOG score: 0-1;
- Expected survival ≥ 3 months;
- Clinical laboratory values meet screening visit criteria
Who cannot join
- Previous CAR-T cell, TCR-T cell or other cell therapies or therapeutic tumor vaccination directed at any target;
- Any previous GPC3 targeted therapy;
- Prior antitumor therapy with insufficient washout period;
- Brain metastases with central nervous system symptoms;
- Pregnant or lactating women
- HCV-Ab or/and HIV-Ab positive; active syphilis;
- Severe underlying diseases
- Any condition that, in the opinion of the investigator, will make the subject unsuitable for participation in this study.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Gobroad Boren Hospital
Beijing, Beijing Municipality
Chinese PLA General Hospital
Beijing, Beijing Municipality
About this study
Official title: A Phase I Clinical Trial for Evaluating the Safety, Tolerance and Efficacy of GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma
A Phase I Clinical Trial for Evaluating the Safety, Tolerance and Efficacy of GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma
Read the detailed description
This is an open-label, dose escalation/expansion study to assess the safety, tolerability, and efficacy of CART cell in patients ≥ 18 years of age with relapsed or refractory advanced hepatocellular carcinoma. Patients who meet the eligibility criteria will receive cell infusion. The study will include the following sequential phases: screening, pre-treatment (cell product preparation; lymphodepleting chemotherapy), treatment and follow up
- Conditions
- Advanced Hepatocellular Carcinoma
- Being tested
- GPC3 Targeting CART Cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GPC3 Targeting CART CellsBiological
before treatment with GPC3 Targeting CART cells, subjects will receive a conditioning regimen
| Study group | Role | What they receive |
|---|---|---|
| GPC3 Targeting CART Cells | Experimental | Each subject will receive GPC3 Targeting CART cells Receives: Biological: GPC3 Targeting CART Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment
Measured: Minimum 2 years after CART infusion (Day 1)
Dose-limiting toxicity (DLT) rate
Dose-limiting toxicity (DLT) refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose.
Measured: Minimum 2 years after CART infusion (Day 1)
Recommended Phase 2 dose (RP2D) finding
RP2D established through ATD+BOIN design
Measured: 30 days after CART infusion (Day 1)
CAR positive T cells
CAR positive T cells after CART infusion
Measured: Minimum 2 years after CART infusion (Day 1)
CAR transgene levels in peripheral blood
CAR transgene levels in peripheral blood after CART infusion
Measured: Minimum 2 years after CART infusion (Day 1)
Secondary outcomes (7)
Overall response rate (ORR)
Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment via CART cell infusion, and the objective tumor response rate will be calculated for patients with measurable disease per RECIST 1.1 only
Measured: Minimum 2 years after CART infusion (Day 1)
Disease control rate (DCR)
Disease Control Rate (DCR) is defined as the proportion of patients with complete response, partial responses and stable disease
Measured: Minimum 2 years after CART infusion (Day 1)
Duration of Response(DoR)
Duration of Remission (DoR) is defined as the time from the first documentation of remission (PR or better) to the first documented disease progression evidence (according to RECIST 1.1) of the responders (who achieve PR or better response)
Measured: Minimum 2 years after CART infusion (Day 1)
Time to Response (TTR)
Time to Response (TTR) is defined as the time from the date of first infusion of CART to the date of the first response evaluation of the subject who has met all criteria for PR or better
Measured: Minimum 2 years after CART infusion (Day 1)
Progress Free Survival (PFS)
Progression Free Survival (PFS) is defined as the time from the date of first infusion of the CART to the first documented disease progression (according to RECIST 1.1) or death (due to any cause), whichever occurs first
Measured: 2 years after CART infusion (Day 1)
Overall Survival (OS)
Overall Survival (OS) is defined as the time from the date of first infusion of CART to death of the subject
Measured: Minimum 2 years after CART infusion (Day 1)
Incidence of anti-CART antibody
Venous blood samples will be collected to measure CART positive cell concentrations and the transgenic level of CART, at the time points when anti-CART antibody serum samples are evaluated
Measured: Minimum 2 years after CART infusion (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2022
- Study start19 May 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Why it stopped: achieve the proof of concept
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- jianming xu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, jianming xu, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352542
- Sponsor's protocol ID
- GPC3-targeting Study
- Status last verified
- Aug 2024
- First submitted
- 1 Apr 2022
- Last updated
- 9 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial for Evaluating the Safety, Tolerance and Efficacy of GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT05352542
- Acronym / sponsor ID
- GPC3-targeting Study
- Conditions
- Advanced Hepatocellular Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: achieve the proof of concept
- Enrolment
- 10 participants (actual)
- Lead sponsor
- jianming xuUniversity, hospital or other
- Study start
- 19 May 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 29 Apr 2022 (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.
A Phase I Clinical Trial for Evaluating the Safety, Tolerance and Efficacy of GPC3-targeting CART Cell in Treatment of Advanced Hepatocellular Carcinoma
Detailed description
This is an open-label, dose escalation/expansion study to assess the safety, tolerability, and efficacy of CART cell in patients ≥ 18 years of age with relapsed or refractory advanced hepatocellular carcinoma. Patients who meet the eligibility criteria will receive cell infusion. The study will include the following sequential phases: screening, pre-treatment (cell product preparation; lymphodepleting chemotherapy), treatment and follow up
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GPC3 Targeting CART Cells | Experimental | Biological: GPC3 Targeting CART CellsEach subject will receive GPC3 Targeting CART cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects have fully understood the possible risks and benefits of participating in this study, are willing to follow and able to complete all trial procedures, and have signed informed consent;
- Age 18-75 years;
- Patients diagnosed as advanced hepatocellular carcinoma (HCC) histopathologically or cytologically; Progression or intolerance after previous standard systemic therapy;
- GPC3 is detected positive by immunohistochemistry (IHC);
- Child-Pugh score ≤ 7;
Key exclusion criteria (8 listed)
- Previous CAR-T cell, TCR-T cell or other cell therapies or therapeutic tumor vaccination directed at any target;
- Any previous GPC3 targeted therapy;
- Prior antitumor therapy with insufficient washout period;
- Brain metastases with central nervous system symptoms;
- Pregnant or lactating women
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 Targeting CART Cellsbefore treatment with GPC3 Targeting CART cells, subjects will receive a conditioning regimen | Biological | GPC3 Targeting CART Cells |
Primary outcome
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
Time frame: Minimum 2 years after CART infusion (Day 1)
An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment
Dose-limiting toxicity (DLT) rate
Time frame: Minimum 2 years after CART infusion (Day 1)
Dose-limiting toxicity (DLT) refers to a drug-related toxicity during treatment with the drug, the severity of which is clinically unacceptable, limiting the further escalation of drug dose.
Recommended Phase 2 dose (RP2D) finding
Time frame: 30 days after CART infusion (Day 1)
RP2D established through ATD+BOIN design
CAR positive T cells
Time frame: Minimum 2 years after CART infusion (Day 1)
CAR positive T cells after CART infusion
CAR transgene levels in peripheral blood
Time frame: Minimum 2 years after CART infusion (Day 1)
CAR transgene levels in peripheral blood after CART infusion
7 secondary outcomes
Overall response rate (ORR)
Time frame: Minimum 2 years after CART infusion (Day 1)
Disease control rate (DCR)
Time frame: Minimum 2 years after CART infusion (Day 1)
Duration of Response(DoR)
Time frame: Minimum 2 years after CART infusion (Day 1)
Time to Response (TTR)
Time frame: Minimum 2 years after CART infusion (Day 1)
Progress Free Survival (PFS)
Time frame: 2 years after CART infusion (Day 1)
Overall Survival (OS)
Time frame: Minimum 2 years after CART infusion (Day 1)
Incidence of anti-CART antibody
Time frame: Minimum 2 years after CART infusion (Day 1)
Results and safety
The study was stopped early (reason given: achieve the proof of concept). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2024.
- Individual participant dataSharing planned: No
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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.
2 sites 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 Targeting CART Cells in people with Advanced Hepatocellular Carcinoma, run by jianming xu at 2 sites 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 8 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: stopped early, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: achieve the proof of concept). 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?
Incidence, severity, and type of treatment-emergent adverse events (TEAEs) (time frame: Minimum 2 years after CART infusion (Day 1)). The study lists 5 primary outcomes in all. 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 9 Aug 2024.