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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
1. Confirmed pathologic or radiologic diagnosis of HCC ;
2. Tumor tissue GPC3 expression positive by immunohistochemistry(IHC) at the local laboratory (Tumor samples ≤1 years prior to ICF signature are acceptable), if no archived tumor tissue samples, tumor biopsy is required for GPC3 expression test;
3. Unresectable stage B (intermediate) or C (advanced) HCC according to the Barcelona Clinic Liver Cancer (BCLC) staging. If stage B, must have progressed after, or not be eligible for, surgical or locoregional therapy;
4. Received at least two prior line of systemic therapy (included but not limited to target therapy, immunotherapy or chemotherapy) with radiologic disease progression during or following systemic therapy;
5. Child-Pugh A or B7, no history of hepatic encephalopathy;
6. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the time of ICF signature;
7. Estimated life expectancy of minimum of 12 weeks;
8. Must have at least 1 target lesion
Exclusion Criteria:
1. Central nervous system metastatic disease, leptomeningeal disease, or metastatic cord compression;
2. Prior bone marrow or organ transplantation;
3. Have a history of another primary malignancy within 5 years prior to starting study treatment. Exceptions here are as follows: the disease under study; adequately treated basal or squamous cell carcinoma of the skin; cancer of the cervix in situ;
4. Active hepatitis B infection (If Hepatitis B surface antigen \[HBsAg\] or Hepatitis B core antibody \[HBcAb\] positive, then HBV-DNA must be \< 20 IU/mL, and HBsAg-positive patients should have been treated with antiviral therapies as per the local guidelines);
5. Positive hepatitis C (HCV) RNA, Human Immunodeficiency Virus (HIV) antibody, Cytomegalovirus(CMV) DNA or syphilis serology;
6. Have received prior cell-based therapies such as targeted GPC3 therapy, TCR-T therapy, CAR-T therapy;
7. Inadequate bone marrow reserve or organ function;
8. History or current evidence of any condition or disease that could confound the results of the study or, in the opinion of Investigator, is not in the best interest of the patient to participate.
9. Pregnant or Breast-feeding women.
Primary outcome measure(s)
Maximum tolerated dose of Ori-C101 — 1 year 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.
Trial sites (7)
Facility
City
Region
Status
Peking University Cancer Hospital
Beijing
Beijing Municipality
Recruiting
Hunan Cancer Hospital
Changsha
Hunan
Recruiting
The first hospital of Jilin University
Changchun
Jilin
Recruiting
West China Hospital
Chengdu
Sichuan
Recruiting
Sir Run Run Shaw Hospital
Hangzhou
Zhejiang
Recruiting
Lishui Central Hospital
Lishui
Zhejiang
Recruiting
Zhongshan Hospital Fudan University
Shanghai
China
Recruiting
More OriCell Therapeutics Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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