Actively Recruiting
Phase I Study of OriC902 in Treatment of Advanced HCC
Led by Peking University · Updated on 2025-03-24
44
Participants Needed
2
Research Sites
161 weeks
Total Duration
On this page
Sponsors
P
Peking University
Lead Sponsor
O
OriCell Therapeutics Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a Phase I clinical study evaluating the safety, pharmacokinetics, and initial efficacy of a GPC3-targeted chimeric antigen receptor autologous T cell injection (OriC902) in GPC3-positive advanced hepatocellular carcinoma (HCC) subjects
CONDITIONS
Official Title
Phase I Study of OriC902 in Treatment of Advanced HCC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign an informed consent form before any study procedures
- Age between 18 and 75 years old at consent
- Diagnosed with hepatocellular carcinoma (HCC) according to 2024 guidelines
- Liver tumor or metastasis tissue sample positive for GPC3 by immunohistochemistry within 1 year
- BCLC stage B or C HCC unsuitable for or relapsed after local therapy and not curable
- Disease progression after standard treatments including targeted therapy, immunotherapy, or chemotherapy
- Child-Pugh class A or B7 without hepatic encephalopathy
- ECOG performance status of 0 or 1
- Expected survival of at least 12 weeks
- At least one measurable lesion by RECIST 1.1 with specific size criteria
- Able to provide venous blood samples and tolerate white blood cell collection
- Investigator judges lymphocyte clearance therapy is possible
- Fertile participants agree to effective contraception from consent until 2 years after study drug use; negative pregnancy test for women of childbearing age
You will not qualify if you...
- Central nervous system metastasis, meningeal metastasis, or spinal cord compression
- History of allogeneic stem cell or organ transplantation
- Other primary cancers within past 3 years except certain cured localized cancers
- Positive for hepatitis B with high viral load without antiviral treatment
- Positive for hepatitis C, HIV, syphilis, CMV, or EBV infection markers
- Allergy to any study drug components including antisepsis drugs
- Previous anti-GPC3 targeted therapy including antibodies or cell therapy
- Intrahepatic tumor occupying more than 50% of liver or major blood vessel cancer thrombus
- Recent chemotherapy, investigational drugs, antibody drugs, targeted drugs, local therapy, radiotherapy, or anti-tumor Chinese medicine within defined timeframes
- Major surgery within 28 days before cell collection or planned during study
- Unresolved toxicity from prior therapy above grade 1 except certain stable cases
- Active uncontrolled infection requiring treatment within 4 weeks before cell collection
- Recent active pulmonary tuberculosis or history within 1 year
- Interstitial lung disease, extensive lung metastasis, or severe lung disease
- Active or past autoimmune diseases that may recur
- Use of systemic corticosteroids or immunosuppressants above defined doses near study start or during study
- Significant cardiovascular diseases
- Insufficient bone marrow or organ function
- Significant bleeding events or high risk of gastrointestinal bleeding
- Poorly controlled fluid buildup judged unsuitable
- Recent live attenuated vaccine within 28 days or planned during study
- History of mental disorders or substance abuse preventing participation
- Pregnancy or breastfeeding
- Other conditions affecting protocol adherence or suitability as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Beijing GoBroad Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
2
Peking University Cancer Hospital & Institute
Beijing, Beijing Municipality, China, 100000
Not Yet Recruiting
Research Team
C
Changsong Qi
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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