Actively Recruiting
Clinical Trial of Autologous CD19 CAR-T Cells (CNCT19) Therapy for Advanced Hepatocellular Carcinoma
Led by Zhejiang University · Updated on 2025-12-15
12
Participants Needed
2
Research Sites
85 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang University
Lead Sponsor
J
Juventas Cell Therapy Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A phase I clinical study of the safety and tolerability, efficacy of CNCT19 CAR T-cell therapy in patients with advanced hepatocellular carcinoma hepatocellular carcinoma.
CONDITIONS
Official Title
Clinical Trial of Autologous CD19 CAR-T Cells (CNCT19) Therapy for Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 80 years, male or female
- Voluntarily participated and signed informed consent
- Pathologically diagnosed hepatocellular carcinoma with China Liver Cancer Staging (CNLC) stage II-III
- Not suitable for surgery or local treatments or have recurrence/progression after surgery/local treatment
- Received at least second-line systemic standardized treatment and have progressed or are intolerant
- At least one measurable tumor lesion by RECIST 1.1
- Tumor samples available within 2 years with CD19/CD68 double positive cells detected
- Child-Pugh score 64; 7 and no history of hepatic encephalopathy
- ECOG performance status 0-1
- Expected survival period of 12 weeks or more
- Toxicity from previous treatments stabilized or recovered to grade 1 or less except clinically insignificant cases
You will not qualify if you...
- Active brain metastasis
- Received or waiting for organ transplantation
- Active autoimmune diseases requiring systemic immunosuppressive therapy within past 2 years
- Intrahepatic tumors comprising more than 50% of liver or tumor thrombus in main portal vein, mesenteric vein, or inferior vena cava
- Received local treatments (surgery, radiation, ablation) within 4 weeks prior to cell collection
- Major surgery or significant trauma within 4 weeks prior to cell collection or expected during study
- Immunotherapy (anti-PD-1, PD-L1) within 1 week prior to cell collection
- Chemotherapy or targeted therapy (sorafenib, regorafenib, lenvatinib) within 2 weeks prior to cell collection
- Therapeutic corticosteroids within 3 days prior to cell collection (topical and inhaled allowed)
- Other incurable malignant tumors within past 5 years except certain in situ or basal cell carcinomas
- Prior other cell therapies or gene modified cell therapies
- Significant central nervous system diseases including epilepsy, stroke, severe brain injury, dementia, Parkinson's, or psychiatric disorders
- Chronic obstructive pulmonary disease, interstitial lung disease, or significant lung function abnormalities
- Large uncontrollable fluid accumulation such as pleural, abdominal, or pericardial effusion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
2
First Affiliated Hospital, Medical College of Zhejiang University
Hangzhou, Zhejiang, China, 310003
Not Yet Recruiting
Research Team
Q
Qi Zhang
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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