Status:
ACTIVE_NOT_RECRUITING
Phase I Clinical Trial of CT0180 Cells in the Treatment of Hepatocellular Carcinoma
Lead Sponsor:
Zhejiang University
Collaborating Sponsors:
CARsgen Therapeutics Co., Ltd.
Conditions:
Advanced Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
A Phase I Clinical Study ofCT0180 cells in Patients with Advanced Hepatocellular Carcinoma
Detailed Description
Primary objectives: Evaluate the safety and tolerance of CT0180 cells in patients with advanced hepatocellular carcinoma within 28 days after the first infusion Secondary objectives: * Evaluate the...
Eligibility Criteria
Inclusion
- Aged 18 to 75 years, either sex；
- Patients with clinically or pathologically confirmed hepatocellular carcinoma were treated with surgery or local treatment It is not suitable for surgery or local radical treatment;
- Progression or intolerance after at least one previous systemic treatment, or due to specific reasons unable to receive systemic treatment. Systemic therapy can include: Programmed Death 1（PD-1） / programmed cell death-Ligand 1（PD-L1） monoclonal antibody Antibodies, molecular targeted drugs (e.g. sorafenib, regofinib, renvastinib)and conventional chemotherapy, etc;
- According to Barcelona Clinic Liver Cancer（BCLC）, the patients are classified into Grade C or Grade B unsuitable for local treatment/progressive disease after local treatment;
- In tumor tissue samples GPC3 is detected positive by immunohistochemistry (IHC);
- According to Response Evaluation Criteria in SolidTumors（RECIST1.1）,patients have at least one evaluable target lesion, defined as: the longest diameter of non-lymph node lesion ≥ 10 mm, or the shortest diameter of lymph node lesion ≥ 15 mm); hepatic lesions require arterial phase contrast enhancement;
- Expected survival is \> 12 weeks;
- Cirrhosis status Child-Pugh score: Grade A;
- Eastern Cooperative Oncology Group（ ECOG） Performance Status score: 0 to 1 point;
- If the patient is HBsAg positive or HBcAb positive, HBV-DNA should be \<2000 IU/ml. HBsAg positive patients must receive antiviral treatment ;
- Acceptable routine blood test showing no contraindication to the lymphodepletion pretreatment and adequate liver, renal, cardiovascular, respiratory function;
- Have venous accesses for apheresis;
- Subjects of childbearing age must undergo a serum pregnancy test within 14 days before the initiation of the study and the result must be negative. In addition, they should be willing to use a reliable method of contraception during the trial (within 52 weeks after cell infusion); male subjects whose spouses are women of childbearing age should undergo sterilization surgery or agree to use a reliable method of contraception during the trial;
- Understand and sign informed consent.
Exclusion
- Pregnant or breast-feeding women;
- Hepatitis virus C antibodies ,human immunodeficiency virus（HIV） antibodies or Syphilis Serological tests are positive;
- Any uncontrol active infection, including but not limited to active tuberculosis;
- Have clinically significant thyroid dysfunction except the stable control after treatment;
- Previous or present hepatic encephalopathy;
- Current clinically significant ascites;
- Imaging results:≥50% of the liver is replaced by tumor or portal vein main tumor thrombus, or metastases to the central nervous system, or tumor thrombus invasion of mesenteric vein / inferior vena cava;
- Patients with a history of organ transplantation or waiting for organ transplantation (including liver transplantation);
- The side effects caused by the previous treatment of the subjects did not return to Common Terminology Criteria for Adverse Events（CTCAE） ≤1; except hair loss and other tolerable events determined by investigator;
- Patients who had received systemic steroids or other immunosuppressive agents within 7 days before apheresis, except inhaled steroids;
- History of severe allergy ,allergic to CT0180 cell fluid adjuvant such as Dimethyl sulfoxide（DMSO）;
- Has signs of central nervous system disease or an abnormal neurological examination with clinical significance;
- Subjects with unstable or active ulcers, gastrointestinal bleeding, or pump inhibitor intolerance;
- Patients with a history of organ transplantation or waiting for organ transplantation;
- Previously received anti-PD-1/ PD-L1 monoclonal antibody therapy within 4 weeks or local treatment and systemic chemotheray within 2 weeks or immunotheray and molecular targeted drugs within 1 week before apheresis;
- Previously received GPC3 targeted therapy;
- Major surgery or significant trauma occurred within 4 weeks before apheresis, or it is expected that major surgery needs to be performed during the trial;
- Patients who had incurable malignant tumors in the past 5 years or at the same time, except cervical cancer in situ and basal cell carcinoma of skin;
- Other serious diseases that may restrict the subjects from participating in the trial ；
- The researcher assessed that the subjects were unable or unwilling to comply with the requirements of the trial protocol.
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04756648
Start Date
March 10 2021
End Date
June 1 2026
Last Update
September 29 2025
Active Locations (1)
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1
First affiliated hospital, Zhejiang University
Hangzhou, Zhejiang, China, 310006