About this trial
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.
Eligibility criteria
Qualifiers
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;
Portal vein tumor thrombus (PVTT);
Hepatic vein tumor thrombus (HVTT);
Disqualifiers
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;
Trial design
Treatments tested in this trial
- CT011 CAR-GPC3 T Cells Injection
Treatment groups
Sponsors and collaborators
CARsgen Therapeutics Co., Ltd.
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator