CT011 Autologous CAR-T Cells in Patients With Hepatocellular Carcinoma at Risk of Recurrence Afte… (NCT06560827) | Clinical Trial Compass
RecruitingPhase 1
CT011 Autologous CAR-T Cells in Patients With Hepatocellular Carcinoma at Risk of Recurrence After Surgical Resection
China30 participantsStarted 2023-10-08
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Volunteer to participate in the clinical trial; fully understand and are informed of this trial and sign the informed consent form; Willing to follow and able to complete all trial procedures;
. Age 18-75 years, inclusive, male or female;
. Initially diagnosed with CNLC stage IIIa HCC with any of the following vascular tumor thrombi and absence of atrial tumor thrombi on preoperative imaging:
. Has undergone surgical resection:
. The participant has recovered from liver resection and postoperative progressive increase in AFP level(including: a. AFP increase of at least 20% in any 3 months after surgery; or b. AFP increase of ≥ 10% in any 2 consecutive tests after surgery) with a potential tendency to recurrence as assessed by the investigator.
. Tumor tissue samples positive for GPC3 by immunohistochemistry (IHC) (staining intensity ≥ 1 +, percentage of stained tumor cells ≥ 10%);
. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (within 7 days prior to apheresis);
. Child-Pugh score ≤ 7 points (within 7 days prior to apheresis);
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence and severity of treatment-emergent adverse events (TEAE)
Timeframe: Up to 12 months
2
Incidence and severity of treatment-related adverse events (TRAE)
Timeframe: Up to 12 months
3
Incidence and severity of adverse events of special interest (AESI)
. Known fibrolamellar HCC, sarcomatoid HCC, or mixed hepatocellular-cholangiocarcinoma;
. Intrahepatic recurrence or extrahepatic metastasis, or residual hepatocellular carcinoma detected before apheresis (imaging evidence according to RECIST v1.1);
. More than 2 years since surgical resection;
. Pregnant or lactating females;
. Positive test results for any of the following: human immunodeficiency virus (HIV) antibody, Treponema pallidum antibody, hepatitis C virus (HCV) ribonucleic acid (RNA), hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) positive and hepatitis B virus deoxyribonucleic acid \[HBV DNA\] ≥ 1000 IU/mL (HBsAg-positive or HBcAb-positive participants must receive antiviral therapy), cytomegalovirus (CMV) DNA, Epstein-Barr virus (EBV) DNA;
. Any uncontrolled active infection, including but not limited to active tuberculosis, infectious diseases requiring systemic treatment, etc.; Patients who use drugs to prevent infection can be enrolled at the discretion of the investigator;
. Subjects with clinically significant abnormal thyroid function (free triiodothyronine \[FT3\], free thyroxine \[FT4\] and serum thyroid stimulating hormone \[TSH\] for serum thyroid hormones, and total thyroxine \[TT4\] and total triiodothyronine \[TT3\] for serum thyroid hormones if necessary) judged by the investigator and not suitable for entry into the trial after assessment; Patients with stable thyroid function after treatment can be considered for inclusion;