GPC3-targeted CAR-T Cell for Treating GPC3 Positive Advanced HCC
NCT ID: NCT04121273
Last Updated: 2021-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
20 participants
INTERVENTIONAL
2019-10-05
2021-11-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CAR-T cells
CAR-T cells targeting GPC3 will be administered to enrolled patients with hepatocellular carcinoma.
CAR-T cell immunotherapy
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.
Interventions
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CAR-T cell immunotherapy
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.
Eligibility Criteria
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Inclusion Criteria
2. 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%.
3. 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.
4. Prothrombin time INR \< 1.7.
5. Ejection fraction (EF) \>= 55%, oxygen saturation (SO2) \> 90%.
6. No allergic reaction to contrast material.
7. Karnofsky score \>= 60%.
8. Child-puge score \<7.
9. Peripheral venous access.
10. Voluntarily signed informed consent.
Exclusion Criteria
2. Systemic steroid treatment ( \>prednisone equivalent/kg/day).
3. Patients with previous history of cell immunotherapy or antibody therapy.
4. Patients received radiotherapy/chemotherapy in the past 4 weeks.
5. Patients are participating in other clinical trials.
6. Patients with uncontrolled symptoms including infection, heart failure, arrhythmia.
7. Patients with acute allergic reaction.
8. History of liver transplantation.
9. Patients with anticoagulant treatment.
10. Patients with hepatic encephalopathy.
11. Eligible for hepatectomy, liver transplantation or other standard treatment.
12. Unstable gastrointestinal and respiratory bleeding.
13. Active viral, fungal or bacterial infections.
14. Heart failure classification (NYHA): II-IV.
15. Patients are unable or unwilling to comply with the requirements of the study protocol.
16. Patients do not meet the criteria above.
18 Years
69 Years
ALL
No
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Responsible Party
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Beicheng Sun
Director of Hepatobiliary Surgery
Locations
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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v1.0 20180620
Identifier Type: -
Identifier Source: org_study_id
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