This is a Phase I, open-label, multi-center study to assess the safety, pharmacokinetics, and preliminary efficacy of GPC3-directed chimeric antigen receptor modified T cells injection (Ori-C101) in Advanced Hepatocellular Carcinoma(HCC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Hepatic arterial infusion
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGHunan Cancer Hospital
Changsha, Hunan, China
RECRUITINGThe first hospital of Jilin University
Changchun, Jilin, China
Maximum tolerated dose of Ori-C101
The MTD is defined as the highest dose with an observed incidence of DLT in no more than one out of six patients treated at a particular dose level.
Time frame: 1 year
Objective Response Rate
Objective response is defined as the participants with a partial response (PR) or better by the RECIST1.1 criteria.
Time frame: 2 years
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West China Hospital
Chengdu, Sichuan, China
RECRUITINGSir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
RECRUITINGLishui Central Hospital
Lishui, Zhejiang, China
RECRUITINGZhongshan Hospital Fudan University
Shanghai, China
RECRUITING