CT011 Autologous CAR-T Cells in Patients With Hepatocellular Carcinoma at Risk of Recurrence After Surgical Resection
NCT Number: NCT06560827
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: HCC
Interventions: BIOLOGICAL: CT011 CAR-GPC3 T Cells Injection
Sponsor: CARsgen Therapeutics Co., Ltd.
Collaborators: Shanghai Zhongshan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 30
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-10-08
Completion Date: 2027-06-30
Locations: Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China|Hunan Provincial People's Hospital, Changsha, China|Sichuan Cancer Hospital, Chengdu, China|West China Hospital of Sichuan University, Chengdu, China|Chongqing university ca cer hospital, Chongqing, China|Mengchao hepatobiliary hospital of fujian medical university, Fuzhou, China|Sun Yat-sen University Cancer Center, Guanzhou, China|Sir Run Run Shaw Hospital Zhejiang University School of Medicine, Hangzhou, China|The second affiliated hospital zhejiang university school of medicine, Hangzhou, China|Zhongshan Hospital Fudan University, Shanghai, China|Liaoning Cancer Hospital, Shenyang, China|The first hospital of china medical university, Shenyang, China|Tianjin medical university cancer hospital, Tianjin, China|Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, Wuhan, China|The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China

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.

Primary Outcome Measures: 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., Up to 12 months|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., Up to 12 months|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., Up to 12 months
Secondary Outcome Measures: 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., Up to 12 months|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)., Up to 12 months|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)., Up to 12 months|Time to intrahepatic recurrence (TT-IHR), The time from the first infusion (D0) to the first recording of intrahepatic recurrence., Up to 12 months|Time to extrahepatic spread (TT-EHS), The time from the first infusion (D0) to the first recording of extrahepatic spread., Up to 12 months|Postoperative recurrence free survival (RFS2), The time from liver resection surgery to the occurrence of intrahepatic recurrence/extrahepatic metastasis or death from any cause, whichever occurs first., Up to 12 months|Overall survival (OS), The time from the first infusion (D0) to the participant's death from any cause., Up to 12 months|OS rates of W24, W48, and W72, the proportion of participants who survived W24, W48, and W72 after the first infusion (D0)., Up to 12 months|AFP control rate (ACR) of W24, W48, and W72, The proportion of participants whose AFP levels reached remission, decrease, and stability at W24, W48, and W72 after the first infusion (D0)., Up to 12 months|To evaluate the cellular metabolic kinetics of CT011, Time to peak expansion (Tmax), Up to 12 months|To evaluate the cellular metabolic kinetics of CT011, peak expansion (Cmax), Up to 12 months|To evaluate the cellular metabolic kinetics of CT011, area under the curve (AUC), Up to 12 months|To evaluate the cellular metabolic kinetics of CT011, continuous survival time (Tlast) of CT011 cells after infusion, Up to 12 months|To evaluate the immunogenicity of CT011, Positive rate of anti-drug antibodies (ADA) after CT011 cell infusion, Up to 12 months