Actively Recruiting
Ori-C101Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of HCC
Led by OriCell Therapeutics Co., Ltd. · Updated on 2024-04-03
105
Participants Needed
7
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Ori-C101Chimeric Antigen Receptor (CAR) Modified T Cells for the Treatment of HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed pathologic or radiologic diagnosis of Hepatocellular Carcinoma (HCC)
- Tumor tissue positive for GPC3 expression by immunohistochemistry within 1 year prior to consent, or tumor biopsy performed for GPC3 testing
- Unresectable stage B or C HCC per Barcelona Clinic Liver Cancer staging; if stage B, must have progressed after or be ineligible for surgery or local therapy
- Received at least two prior systemic therapies with disease progression during or after treatment
- Child-Pugh class A or B7 with no history of hepatic encephalopathy
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at consent
- Estimated life expectancy of at least 12 weeks
- Presence of at least one target lesion
You will not qualify if you...
- Central nervous system metastases, leptomeningeal disease, or metastatic spinal cord compression
- Prior bone marrow or organ transplantation
- History of another primary cancer within 5 years, except for adequately treated basal or squamous cell skin cancer or cervical cancer in situ
- Active hepatitis B infection with HBV-DNA ≥ 20 IU/mL or untreated HBsAg-positive patients
- Positive tests for hepatitis C RNA, HIV antibody, cytomegalovirus DNA, or syphilis
- Previous cell-based therapies such as targeted GPC3 therapy, TCR-T, or CAR-T therapy
- Inadequate bone marrow or organ function
- Any condition that could interfere with study results or patient safety as judged by the investigator
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Peking University Cancer Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
2
Hunan Cancer Hospital
Changsha, Hunan, China
Actively Recruiting
3
The first hospital of Jilin University
Changchun, Jilin, China
Actively Recruiting
4
West China Hospital
Chengdu, Sichuan, China
Actively Recruiting
5
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
6
Lishui Central Hospital
Lishui, Zhejiang, China
Actively Recruiting
7
Zhongshan Hospital Fudan University
Shanghai, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here