Actively Recruiting
CT011 Autologous CAR-T Cells in Patients With Hepatocellular Carcinoma at Risk of Recurrence After Surgical Resection
Led by CARsgen Therapeutics Co., Ltd. · Updated on 2024-08-19
30
Participants Needed
15
Research Sites
194 weeks
Total Duration
On this page
Sponsors
C
CARsgen Therapeutics Co., Ltd.
Lead Sponsor
S
Shanghai Zhongshan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
A Single-arm, Open-label, Multicenter, Phase Ib Clinical Trial to Evaluate the Safety and Efficacy of CT011 Autologous CAR-T Cells in Patients with Hepatocellular Carcinoma at Risk of Recurrence after Surgical Resection.
CONDITIONS
Official Title
CT011 Autologous CAR-T Cells in Patients With Hepatocellular Carcinoma at Risk of Recurrence After Surgical Resection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer and able to complete all trial procedures with informed consent
- Aged 18 to 75 years, male or female
- Diagnosed with CNLC stage IIIa HCC with vascular tumor thrombi (portal vein, hepatic vein, or inferior vena cava) and no atrial tumor thrombi
- Have undergone surgical resection with negative margins
- Recovered from liver resection and showing progressive increase in AFP levels indicating potential recurrence
- Tumor tissue positive for GPC3 by immunohistochemistry with required staining intensity and percentage
- ECOG performance status of 0 or 1 within 7 days prior to apheresis
- Child-Pugh score of 7 points or less within 7 days prior to apheresis
- Estimated survival longer than 12 weeks
- Adequate venous access for apheresis
- Laboratory test results within specified ranges within 7 days prior to apheresis
- Female participants of childbearing potential must have a negative pregnancy test and agree to use highly effective contraception during treatment and for 1 year after
- Male participants sexually active with females of childbearing potential must agree to use contraception or abstain during treatment and for 1 year after
You will not qualify if you...
- Known fibrolamellar HCC, sarcomatoid HCC, or mixed hepatocellular-cholangiocarcinoma
- Intrahepatic recurrence, extrahepatic metastasis, or residual HCC detected before apheresis
- More than 2 years since surgical resection
- Pregnant or lactating females
- Positive for HIV, syphilis, HCV RNA, hepatitis B markers with high viral load, CMV DNA, or EBV DNA
- Any uncontrolled active infection requiring systemic treatment
- Clinically significant abnormal thyroid function not stable or suitable for trial
- Previous or current hepatic encephalopathy
- Clinically significant abdominal or pleural effusion requiring intervention
- Unresolved toxicities from previous treatments above Grade 1 except certain exceptions
- Anti-tumor treatment within 2 weeks prior to apheresis
- Immunotherapy within 4 weeks prior to apheresis
- Previous cell therapy including CAR-T
- Systemic glucocorticoid therapy within 7 days prior to apheresis except certain uses
- Vaccination with live vaccines within 4 weeks prior to apheresis or planned during trial
- Known active autoimmune disease or chronic immunosuppressive therapy
- History of organ transplantation or awaiting transplantation
- Allergies to immunotherapy or related drugs or components of CT011
- Central nervous system metastasis or significant neurological or psychiatric disease
- Need for long-term anticoagulation therapy except prophylactic use
- Major surgery or significant trauma within 4 weeks prior to apheresis or planned during trial
- Pre-apheresis oxygen saturation 95% or less
- Other diseases or conditions contraindicating trial participation or affecting result interpretation
- Presence of other incurable malignancies within past 5 years except certain low-risk cancers
- Inability or unwillingness to comply with trial requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 15 locations
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
2
Hunan Provincial People's Hospital
Changsha, China
Actively Recruiting
3
Sichuan Cancer Hospital
Chengdu, China
Actively Recruiting
4
West China Hospital of Sichuan University
Chengdu, China
Actively Recruiting
5
Chongqing university ca cer hospital
Chongqing, China
Actively Recruiting
6
Mengchao hepatobiliary hospital of fujian medical university
Fuzhou, China
Actively Recruiting
7
Sun Yat-sen University Cancer Center
Guanzhou, China
Actively Recruiting
8
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, China
Actively Recruiting
9
The second affiliated hospital zhejiang university school of medicine
Hangzhou, China
Actively Recruiting
10
Zhongshan Hospital Fudan University
Shanghai, China
Actively Recruiting
11
Liaoning Cancer Hospital
Shenyang, China
Actively Recruiting
12
The first hospital of china medical university
Shenyang, China
Actively Recruiting
13
Tianjin medical university cancer hospital
Tianjin, China
Actively Recruiting
14
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, China
Actively Recruiting
15
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Actively Recruiting
Research Team
L
Lifeng Zhang
CONTACT
T
Tianci Su
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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