A phase I clinical study of the safety and tolerability, efficacy of CNCT19 CAR T-cell therapy in patients with advanced hepatocellular carcinoma hepatocellular carcinoma.
This is a single-arm, dose-escalation, open, exploratory clinical study to evaluate the safety and tolerability, preliminary efficacy and PK/PD haracteristics of CNCT19 CAR T-cell therapy in the treatment of advanced hepatocellular carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
All subjects were intravenous administrated with CNCT19 CAR-T.
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGFirst Affiliated Hospital, Medical College of Zhejiang University
Hangzhou, Zhejiang, China
NOT_YET_RECRUITINGDose limiting toxicity (DLT)
Describe the adverse events of limiting further increases in the dose of CNCT19.
Time frame: Within 28 days of CNCT19infusion
Adverse events
Describe adverse events (AEs) and serious adverse events (SAEs) that are "likely" or "definitely" related to the studytreatment that occur at any time of 24 months after treatment.
Time frame: Within 24 months after the treatment
Maximum tolerated dose
Determine the optimal agent for CNCT19 at maximum tolerated dose.
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 3 years)
Effectiveness evaluation
Objective response rate by RECIST 1.1.
Time frame: From treatment of the first subject to completion of follow-up of the last subject (up to 3 years)
Effectiveness evaluation
Progression-free survival by RECIST 1.1
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Effectiveness evaluation
Duration of response by RECIST 1.1
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Effectiveness evaluation
Time to response by RECIST 1.1
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 3 years)
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Effectiveness evaluation
Disease control time by RECIST 1.1
Time frame: From enrollment of the first subject to completion of follow-up of the last subject (up to 5 years)
Pharmacokinetic evaluation
Detect duration of CAR-T cells in vivo.
Time frame: Within 28 days of CNCT19 infusion
Pharmacokinetic evaluation
Detect expansion of CAR-T cells in vivo.
Time frame: Within 28 days of CNCT19 infusion