Actively Recruiting
Clinical Study of SN301A Injection in the Treatment of Hepatocellular Carcinoma
Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2024-11-25
12
Participants Needed
1
Research Sites
153 weeks
Total Duration
On this page
Sponsors
S
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor
C
Celest Therapeutics Co. Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a single-arm, open-label study of safety, tolerability, and anti-cancer activity of SN301A (an off-the-shelf CAR NK cell therapy) in patients with glypican-3 (GPC3)-positive advanced hepatocellular carcinoma.
CONDITIONS
Official Title
Clinical Study of SN301A Injection in the Treatment of Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent and able to follow study visits and procedures
- Age between 18 and 70 years, any gender
- Diagnosed hepatocellular carcinoma positive for glypican-3 by immunohistochemistry
- Unresectable Stage B or C hepatocellular carcinoma per BCLC guidelines with disease progression or unsuitable for surgery/local therapy
- Failed at least one prior systemic therapy including PD-1/L1 or tyrosine kinase inhibitors
- Child-Pugh class A or B (7 points) without history of hepatic encephalopathy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Life expectancy of at least 12 weeks
- At least one measurable lesion by RECIST v1.1 or mRECIST criteria
- Willing to provide fresh or archival tumor tissue samples within 2 years
- Adequate organ and bone marrow function meeting specified laboratory criteria
- Agree to use effective contraception and have negative pregnancy test if applicable
You will not qualify if you...
- Central nervous system metastases including brain or meningeal metastases
- Previous bone marrow or organ transplant or waiting for transplant
- History of other cancers except certain treated localized cancers
- Active hepatitis B or C infection, HIV, or syphilis infection
- Positive for HLA antibodies (except mismatched to study product)
- Prior treatment with cellular therapies or GPC3-targeted agents
- Recent chemotherapy, biological agents, radiotherapy, or traditional Chinese medicine with antitumor effect within specified timeframes
- Unresolved severe adverse events from prior cancer treatments
- Recent live vaccine immunization or need for such vaccines during the study
- Recent major surgery or planned major surgery during study
- Use of systemic corticosteroids or immunosuppressives (with exceptions)
- Active infections requiring systemic treatment
- Active or prior autoimmune diseases
- Significant lung diseases or severely impaired lung function
- Uncontrolled fluid accumulations like pleural effusion or ascites
- Serious cardiovascular or cerebrovascular diseases or conditions
- History of pulmonary embolism or severe deep vein thrombosis requiring intervention
- Extensive tumor involvement in the liver or major vessel invasion with complications
- Participation in another interventional clinical trial
- Pregnant or breastfeeding women
- Any condition that might affect study compliance or suitability per investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
Research Team
Q
Qi Li, MD
CONTACT
J
Jingyi Zhou, MD
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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