Actively Recruiting
Study of GPC-3 CAR-T Cells in Treating With Hepatocellular Carcinoma
Led by Shenzhen University General Hospital · Updated on 2022-11-22
20
Participants Needed
1
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Hepatocellular carcinoma is a highly heterogeneous disease. Treatment strategies for advanced hepatocellular carcinoma are limited. Phosphatidylinositol proteoglycan 3 (GPC3) is a heparan sulfate glycoprotein (HSPG) on the surface of the cell membrane. It is highly expressed in liver cancer tissues, but hardly expressed in normal liver tissues. It is an ideal target for tumor treatment. Investigators aimed to test the safety and efficacy of GPC3 CAR-T cells in patients with advanced hepatocellular carcinoma.
CONDITIONS
Official Title
Study of GPC-3 CAR-T Cells in Treating With Hepatocellular Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 70 years old
- Diagnosed with advanced hepatocellular carcinoma by histopathology or cytology
- Not suitable for surgery or local treatment and have progressed or are intolerant to standard treatments
- Stopped ineffective PD-1 monoclonal antibody treatment more than 28 days ago
- At least one measurable target lesion according to RECIST 1.1
- Tumor tissue positive for GPC3 by immunohistochemistry
- Barcelona liver cancer grade C or grade B unsuitable for local treatment or with progression
- Estimated survival time longer than 12 weeks
- Cirrhotic state Child Pugh score Grade A
- ECOG physical status score 0 to 1
- If positive for HBsAg or HBcAb, HBV-DNA less than 200 IU/ml and receiving antiviral treatment if HBsAg positive
- Single vein access available
- Blood routine tests within specified limits (WBC ≥ 2.5 × 10⁹/L, PLT ≥ 60 × 10⁹/L, Hb ≥ 9.0 g/dL, LY ≥ 0.4 × 10⁹/L)
- Blood biochemistry within specified limits (serum albumin ≥ 30 g/L, lipase and amylase ≤ 1.5 ULN, creatinine ≤ 1.5 ULN, creatinine clearance ≥ 40 mL/min, ALT ≤ 5 ULN, AST ≤ 5 ULN, total bilirubin ≤ 2.5 ULN, prothrombin time extension ≤ 4 seconds)
- Women of childbearing age must have a negative pregnancy test before starting and agree to reliable contraception during the study; male partners must be sterilized or agree to contraception
- Able to understand and sign informed consent form
You will not qualify if you...
- Pregnant or breastfeeding women
- Positive for HCV-RNA, HIV antibody, or syphilis antibody
- Uncontrolled active infections including active tuberculosis
- Use of systemic steroids equivalent to >15 mg prednisone within 2 weeks before collection (except inhaled steroids)
- Allergies to immunotherapy, related drugs, or lactam antibiotics
- Previous or current hepatic encephalopathy
- Clinically significant ascites requiring intervention
- Liver tumor involvement ≥ 50%, portal trunk tumor thrombus, or tumor thrombus invading major veins
- Central nervous system metastasis or significant central nervous system diseases
- Uncontrolled heart disease or hypertension (systolic >160 mmHg or diastolic >100 mmHg)
- Active autoimmune diseases requiring immunosuppressants
- History of or pending organ transplantation
- Treatment for study disease within 2 weeks before collection
- Prior GPC3 targeted, TCR-T, or CAR-T treatments within the past month
- Anti PD-1/PD-L1 monoclonal antibody treatment within 28 days
- Other incurable cancers within 5 years except certain skin and cervical cancers
- Serious diseases limiting participation, including poorly controlled diabetes, severe cardiac insufficiency, recent cardiovascular events, pulmonary embolism, severe lung disease, gastric ulcers, or bleeding tendencies
- Inability or unwillingness to follow study protocol requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Li Yu
Shenzhen, Guangdong, China, 518000
Actively Recruiting
Research Team
L
Li Yu, Dr
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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