Hepatocellular CarcinomaPhase 1NCT04121273
GPC3-targeted CAR-T Cell for Treating GPC3 Positive Advanced HCC
A Phase 1 study testing CAR-T cell immunotherapy in people with Hepatocellular Carcinoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
Patients with hepatocellular carcinoma (a type of primary liver cancers) are enrolls in this study. The cancer has progressed after standard treatment, or the patient cannot receive regular treatment. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- CAR-T cell immunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 5 Oct 2019to 1 Nov 2021
- 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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GPC3 positive HCC, tumor size >= 5 cm, cannot receive standard treatment, Expected survival time>=3 months.
- Routine blood test: white blood cell count（WBC)>= 2.5×10^9/L, hemoglobin (Hb)>= 9.0 g/dL, blood platelet >= 60×10^9/L, Lymphocyte percentage>=15%.
- Blood biochemical parameters: ALB >= 30 g/L, ALT <= 5 times of the normal value, AST <= 5 times of the normal value, serum lipase<=1.5 times of the normal value, serum amylase<=1.5 times of the normal value， total bilirubin <= 2.5 times of the normal value.
- Prothrombin time INR < 1.7.
- Ejection fraction (EF) >= 55%, oxygen saturation (SO2) > 90%.
- No allergic reaction to contrast material.
Show all 10Show fewer
- Karnofsky score >= 60%.
- Child-puge score <7.
- Peripheral venous access.
- Voluntarily signed informed consent.
Who cannot join
- Pregnancy or lactation.
- Systemic steroid treatment ( >prednisone equivalent/kg/day).
- Patients with previous history of cell immunotherapy or antibody therapy.
- Patients received radiotherapy/chemotherapy in the past 4 weeks.
- Patients are participating in other clinical trials.
- Patients with uncontrolled symptoms including infection, heart failure, arrhythmia.
Show all 16Show fewer
- Patients with acute allergic reaction.
- History of liver transplantation.
- Patients with anticoagulant treatment.
- Patients with hepatic encephalopathy.
- Eligible for hepatectomy, liver transplantation or other standard treatment.
- Unstable gastrointestinal and respiratory bleeding.
- Active viral, fungal or bacterial infections.
- Heart failure classification (NYHA): II-IV.
- Patients are unable or unwilling to comply with the requirements of the study protocol.
- Patients do not meet the criteria above.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Wenfang Tian, PhD, 8613675104348, tiancpu@163.com
About this study
Official title: Clinical Study of GPC3-targeted Chimeric Antigen Receptor T Cells fo Treating Advanced Hepatocellular Carcinoma
Patients with hepatocellular carcinoma (a type of primary liver cancers) are enrolls in this study. The cancer has progressed after standard treatment, or the patient cannot receive regular treatment.
Investigator made a gene called chimeric antigen receptor derived from an antibody that recognizes Glypican 3, a protein detected in in a large proportion of hepatocellular carcinoma. The gene will introduce into T cell from patient's blood to make them recognize and kill cancer cells.
The aim of this study is to evaluate the efficacy, tolerance and safety of chimeric antigen receptor-modified T (CAR-T) cell targeting Glypican 3 for advanced hepatocellular carcinoma.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- CAR-T cell immunotherapy
- Keywords
- chimeric antigen receptor T cell (CAR- T), glypican-3 (GPC3), hepatocellular carcinoma (HCC)
- Medical subject headings
- Carcinoma, Hepatocellular, Simpson-Golabi-Behmel syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-T cell immunotherapyBiological
Patients enrolled will recieve three different doses of the CAR-T cell every two weeks as follows:
Dose 1: 1x10^7/m2
Dose 2: 3x10^7/m2
Dose 3: 1x10^8/m2
The cell numbers are calculated according to CAR-positive T cells.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T cells | Experimental | CAR-T cells targeting GPC3 will be administered to enrolled patients with hepatocellular carcinoma. Receives: Biological: CAR-T cell immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patient with dose limiting toxicity
After each dose of T cell infusion, the adverse effects related to T cell therapy such as fever and jaundice are observed.
Measured: 2 months
Secondary outcomes (3)
Radiological evaluation of tumor size after CAR- T immunotherapy
Evaluate the therapeutic effect of CAR-T immunotherapy radiological observation of the tumor size after infusion of CAR-T cells.
Measured: 3 months
Peripheral tumor marker
After CAR-T cell infusion, alpha fetoprotein (AFP) will be tested regularly in blood.
Measured: 3 months
Number of Peripheral CAR-T cell
The number and proliferation in vivo are tested with Flow Cytometry regularly.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start5 Oct 2019
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Nov 2021 (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.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beicheng Sun, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121273
- Sponsor's protocol ID
- v1.0 20180620
- Status last verified
- Mar 2021
- First submitted
- 8 Oct 2019
- Last updated
- 3 Mar 2021
- Results posted
- 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 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of GPC3-targeted Chimeric Antigen Receptor T Cells fo Treating Advanced Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT04121273
- Acronym / sponsor ID
- v1.0 20180620
- Conditions
- Hepatocellular Carcinoma
- Keywords
- chimeric antigen receptor T cell (CAR- T), glypican-3 (GPC3), hepatocellular carcinoma (HCC)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 5 Oct 2019 (actual)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 9 Oct 2019 (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.
Patients with hepatocellular carcinoma (a type of primary liver cancers) are enrolls in this study. The cancer has progressed after standard treatment, or the patient cannot receive regular treatment.
Investigator made a gene called chimeric antigen receptor derived from an antibody that recognizes Glypican 3, a protein detected in in a large proportion of hepatocellular carcinoma. The gene will introduce into T cell from patient's blood to make them recognize and kill cancer cells.
The aim of this study is to evaluate the efficacy, tolerance and safety of chimeric antigen receptor-modified T (CAR-T) cell targeting Glypican 3 for advanced hepatocellular carcinoma.
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 cells | Experimental | Biological: CAR-T cell immunotherapyCAR-T cells targeting GPC3 will be administered to enrolled patients with hepatocellular carcinoma. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- GPC3 positive HCC, tumor size >= 5 cm, cannot receive standard treatment, Expected survival time>=3 months.
- Routine blood test: white blood cell count（WBC)>= 2.5×10^9/L, hemoglobin (Hb)>= 9.0 g/dL, blood platelet >= 60×10^9/L, Lymphocyte percentage>=15%.
- Blood biochemical parameters: ALB >= 30 g/L, ALT <= 5 times of the normal value, AST <= 5 times of the normal value, serum lipase<=1.5 times of the normal value, serum amylase<=1.5 times of the normal value， total bilirubin <= 2.5 times of the normal value.
- Prothrombin time INR < 1.7.
- Ejection fraction (EF) >= 55%, oxygen saturation (SO2) > 90%.
Key exclusion criteria (16 listed)
- Pregnancy or lactation.
- Systemic steroid treatment ( >prednisone equivalent/kg/day).
- Patients with previous history of cell immunotherapy or antibody therapy.
- Patients received radiotherapy/chemotherapy in the past 4 weeks.
- Patients are participating in other clinical trials.
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 cell immunotherapyPatients enrolled will recieve three different doses of the CAR-T cell every two weeks as follows: Dose 1: 1x10^7/m2 Dose 2: 3x10^7/m2 Dose 3: 1x10^8/m2 The cell numbers are calculated according to CAR-positive T cells. | Biological | CAR-T cells |
Primary outcome
Number of patient with dose limiting toxicity
Time frame: 2 months
After each dose of T cell infusion, the adverse effects related to T cell therapy such as fever and jaundice are observed.
3 secondary outcomes
Radiological evaluation of tumor size after CAR- T immunotherapy
Time frame: 3 months
Peripheral tumor marker
Time frame: 3 months
Number of Peripheral CAR-T cell
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Hepatocellular Carcinoma
Not yet recruitingPhase 2
NIVO+IPI Neoadjuvant Therapy for Recurrent Resectable HCC
Hepatocellular Carcinoma (HCC), Recurrent Hepatocellular Cancer
Active, not recruitingObservational study
Liver Cancer Registry Platform
Hepatocellular Carcinoma (HCC), Cholangiocarcinoma
Active, not recruitingPhase 2
Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruiting
Characterizing Tumor Hypoxia With BOLD-MRI to Predict Y-90 Treatment Response
Hepatocellular Carcinoma, Liver Cancer
Active, not recruitingObservational study
Detect and Expunge Concealed Tumors of the Liver
Liver Cancer
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.
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 CAR-T cell immunotherapy in people with Hepatocellular Carcinoma, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 10 inclusion and 16 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 3 Mar 2021. 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?
Contact Decai Yu, MD (8613701585023, yudecai@nju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patient with dose limiting toxicity (time frame: 2 months). 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 3 Mar 2021.