Actively Recruiting
GPC3-directed CAR-T in the Treatment Amongst Subjects With Advanced Hepatocellular Carcinoma
Led by RenJi Hospital · Updated on 2023-07-03
12
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infused autologous armored GPC3-directed CAR-T in patients with advanced hepatocellular carcinoma refractory to prior systematic treatments.
CONDITIONS
Official Title
GPC3-directed CAR-T in the Treatment Amongst Subjects With Advanced Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years, male or female
- Willing to participate and sign informed consent
- Life expectancy of 12 weeks or more
- ECOG performance status of 0 or 1
- Histologically confirmed hepatocellular carcinoma
- No expected benefit from surgery or local therapies at screening
- Disease progression after at least one prior systemic treatment with limited benefit from current guidelines
- GPC-3 positive tumor tissue with intensity ++ or +++ confirmed by immunohistochemistry
- At least one measurable lesion per RECIST v1.1
- Manageable lung metastasis
- Barcelona Clinic Liver Cancer stage B or C and Child-Pugh score 7 or less
- No active hepatitis B virus infection
- Adequate organ functions
- Adequate venous access for apheresis
- Previous non-hematological adverse events recovered to CTCAE grade 1 or less, except alopecia and peripheral neuropathy
- Women of childbearing potential must use reliable contraception from 28 days before lymphodepletion to 1 year after infusion
- Male patients with sexual activity with women of childbearing potential must use barrier contraception from lymphodepletion to 1 year after infusion; sperm donation prohibited during study
- Women of childbearing potential must have negative serum beta-hCG at screening and 48 hours before lymphodepletion
You will not qualify if you...
- Cholangiocarcinoma or mixed hepatocellular cholangiocarcinoma
- Active brain metastasis
- Primary or infused lesions larger than 15 cm or other risks unsuitable for study
- Another primary cancer within 3 years, except certain early-stage tumors fully removed
- Systemic autoimmune disorders needing long-term immunosuppression
- Previous treatment with genetically engineered T cell therapies like CAR-T or TCR-T
- Active hepatitis C, HIV, or syphilis infections
- History of organ transplant
- Uncontrolled or active infections at screening, before apheresis, lymphodepletion, or infusion
- Severe cardiovascular disease
- Clinically relevant central nervous system disorders
- Current hepatic encephalopathy
- Grade 2 or higher bleeding within 30 days before screening or need for long-term anticoagulants
- Active digestive ulcers or gastrointestinal bleeding within 3 months before screening
- Pregnant or breastfeeding women
- Insufficient washout period for apheresis
- Inability or unwillingness to comply with study protocol
- Other conditions making participation inappropriate
- Previous allergy or intolerance to JWATM214 or its components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, China, 200127
Actively Recruiting
Research Team
H
Hao Feng, MD.,Ph.D
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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