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.
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);
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;
Single group
CT011 CAR-GPC3 T Cells Injection
Biological/VaccineThe dose selection for this trial was mainly based on the preliminary safety and efficacy results of CT011-HCC-01 trial in subjects with advanced HCC, in which 3 and 5 subjects in the 2.5 × 108 cell and 5.0 × 108 cell dose groups, respectively, completed a single infusion of CT011. The results showed that the two dose groups of CT011 were generally well tolerated in HCC subjects who failed to standard treatment, with controllable safety, and showed preliminary anti-tumor efficacy.
Incidence and severity of treatment-emergent adverse events (TEAE)
According to the two-level classification of System Organ Classification (SOC) and Preferred Term, calculate the number and incidence of each type of AE separately; List and describe the severity of AE and its relationship with experimental treatment.
Incidence and severity of treatment-related adverse events (TRAE)
List the AE related to the experimental treatment separately, and calculate the number and incidence of adverse events (TRAEs) related to the experimental treatment.
Incidence and severity of adverse events of special interest (AESI)
Regardless of the causal relationship, the following events occurring after CAR-T cell infusion until 12 months after the last infusion are considered AESI: any ≥ grade 3 CRS; ≥ Level 3 HLH; Any ICANS level ≥ 3; Any grade ≥ 2 infusion related reaction (IRR); Any grade 3 or higher allergic reactions, etc. Evaluate the incidence and rate of AESI.
Recurrence free survival (RFS)
The time from the first infusion (D0) to the occurrence of intrahepatic recurrence/extrahepatic metastasis or death from any cause, whichever occurs first.
W24, W48, and W72 RFS rates
The proportion of participants who survived and did not experience intrahepatic recurrence/extrahepatic metastasis at W24, W48, and W72 after the first infusion (D0).
Time to recurrence (TTR)
The time from the first infusion (D0) to the first recording of intrahepatic recurrence and/or extrahepatic metastasis (whichever occurs first).
Time to intrahepatic recurrence (TT-IHR)
The time from the first infusion (D0) to the first recording of intrahepatic recurrence.
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CARsgen Therapeutics Co., Ltd.
Lead sponsor
Shanghai Zhongshan Hospital
Collaborator
