GPC3-targeted CAR-T Cell for Treating GPC3 Positive Advanced HCC

Nanjing University

Status and phase: Unknown; Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Biological: CAR-T cell immunotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04121273

v1.0 20180620

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. GPC3 positive HCC, tumor size >= 5 cm, cannot receive standard treatment, Expected survival time>=3 months.
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

1. Pregnancy or lactation.
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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

CAR-T cells

Experimental group

Description:

CAR-T cells targeting GPC3 will be administered to enrolled patients with hepatocellular carcinoma.

Treatment:

Biological: CAR-T cell immunotherapy