To Evaluate the Safety, Tolerability and Preliminary Efficacy of EU307, Autologous Glypican 3 (GPC3) Targeted Chimeric Antigen Receptor T cell therapy in Patients with GPC3 Positive Advanced Hepatocellular Carcinoma who Have Failed Standard Therapy
A Dose-escalation, Single-arm, Open-Label, Phase 1 Study
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
* Dose to be administered: a single dose * IV administration * Dosing rate: To be administrated at a rate of approximately 2 mL/min
National Cancer Center
Gyeonggi-do, South Korea
RECRUITINGSeverance Hospital
Seoul, South Korea
RECRUITINGSoonChunHyang University Hospital Seoul
Seoul, South Korea
RECRUITINGAEs (including DLT)
In this study, DLT is defined as an AE related to the IP (EU307),and severity will be assessed according to NCI-CTCAE v5.0
Time frame: up to 6 month from LPI
Production of replication competent lentiviruses (RCL)
Time frame: up to 6 month from LPI
Development of anti-drug antibodies (ADA)
Time frame: up to 6 month from LPI
ORR
Proportion of subjects with confirmed CR or partial response (PR) as best overall response (BOR)
Time frame: up to 6 month
DoR
Time from confirmed tumor response (CR or PR) to confirmed progressive disease (PD)
Time frame: up to 6 month
DCR
Proportion of subjects with confirmed CR, PR, or stable disease (SD) (≥ 6 weeks) as BOR
Time frame: up to 6 month
TTR
Time from IP dosing to confirmed objective response (CR or PR)
Time frame: up to 6 month
TTP
Time from IP dosing to PD
Time frame: up to 6 month
PFS
Time from IP dosing to PD or all-cause death, whichever is earlier
Time frame: up to 6 month
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The Catholic University of Korea Seoul ST.MARY'S Hospital.
Seoul, South Korea
RECRUITINGOS
Time from IP dosing to all-cause death
Time frame: up to 6 month