Clinical Trial of Autologous GPC3 CAR-T Cells (CBG166) Therapy for Advanced Hepatocellular Carcinoma
NCT Number: NCT06461624
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Hepatocellular Carcinoma
Interventions: BIOLOGICAL: anti-GPC3 CAR-T
Sponsor: Zhejiang University
Collaborators: Carbiogene Therapeutics Co. Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 15
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-01
Completion Date: 2027-10-31
Locations: First Affiliated Hospital, Medical College of Zhejiang University, Hangzhou, Zhejiang, 310003, China|the First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang, 310009, China

Summary:
A phase I clinical study of 4th generation chimeric antigen receptor T Cells targeting glypican-3 ( CAR-GPC3 T Cells) in patients with advanced hepatocellular carcinoma.

Primary Outcome Measures: Dose limiting toxicity (DLT), Describe the adverse events of limiting further increases in the dose of CBG166., Within 28 days of CAG166 infusion|Adverse events, Describe adverse events (AEs) and serious adverse events (SAEs) that are "likely" or "definitely" related to the study treatment that occur at any time of 24 months after treatment., Within 24 months after the treatment|Maximum tolerated dose, Determine the optimal agent for CBG166 CAR-T at maximum tolerated dose., From enrollment of the first subject to completion of follow-up of the last subject (up to 3 years)
Secondary Outcome Measures: Effectiveness evaluation, Objective response rate by RECIST 1.1, At weeks 4, 8, and 18 and months 3, 4, 6, 9, 12, 15, 18 and 24 after cell infusion|Effectiveness evaluation, Progression-free survival by RECIST 1.1, The efficacy is evaluated at weeks 4, 8, and 18 and months 3, 4, 6, 9, 12, 15, 18 and 24 after cell infusion|Effectiveness evaluation, Duration of response by RECIST 1.1, The efficacy is evaluated at weeks 4, 8, and 18 and months 3, 4, 6, 9, 12, 15, 18 and 24 after cell infusion|Effectiveness evaluation, Time to response by RECIST 1.1, The efficacy is evaluated at weeks 4, 8, and 18 and months 3, 4, 6, 9, 12, 15, 18 and 24 after cell infusion|Effectiveness evaluation, Disease control time by RECIST 1.1, The efficacy is evaluated at weeks 4, 8, and 18 and months 3, 4, 6, 9, 12, 15, 18 and 24 after cell infusion|Pharmacokinetic evaluation, Detect duration and expansion of CAR-T cells in vivo, Within 24 months after the treatment|Pharmacodynamic evaluation, The copy number of HBV DNA in blood, At weeks 4, 8, and 18 and months 3, 4, 6, 9, 12, 15, 18 and 24 after cell infusion|Pharmacodynamic evaluation, The serum level of IFN-α2, At day 1, 4, 7, 15 and 21 and weeks 4, 8, and 18 and months 3, 4, 6, 9, 12, 15, 18 and 24 after cell infusion|Pharmacodynamic evaluation, The serum level of TGF-β, At weeks 4, 8, and 18 and months 3, 4, 6, 9, 12, 15, 18 and 24 after cell infusion|Pharmacodynamic evaluation, The serum level of soluble AFP, At weeks 4, 8, and 18 and months 3, 4, 6, 9, 12, 15, 18 and 24 after cell infusion|Pharmacodynamic evaluation, The serum level of soluble GPC3, At weeks 4, 8, and 18 and months 3, 4, 6, 9, 12, 15, 18 and 24 after cell infusion|Pharmacodynamic evaluation, The serum levels of cytokine/chemokin, At day 1, 4, 7, 15 and 21 and weeks 4, 8, and 18 and months 3, 4, 6, 9, 12, 15, 18 and 24 after cell infusion