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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
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.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
RECRUITINGNumber 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.
Time frame: 2 months
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.
Time frame: 3 months
Peripheral tumor marker
After CAR-T cell infusion, alpha fetoprotein (AFP) will be tested regularly in blood.
Time frame: 3 months
Number of Peripheral CAR-T cell
The number and proliferation in vivo are tested with Flow Cytometry regularly.
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.