A Phase 1 interventional study of CAR-GPC3 T Cells in Hepatocellular Carcinoma, sponsored by CARsgen Therapeutics Co., Ltd.. Completed at 6 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-02-24.
Sponsored by CARsgen Therapeutics Co., Ltd. · Phase 1, Interventional, and Treatment
A Phase I Clinical Study of Chimeric Antigen Receptor T Cells Targeting Glypican-3 (CAR-GPC3 T Cells) in Patients with Advanced Hepatocellular Carcinoma
This is a phase I open-label, single-arm, multicenter clinical trial designed to observe and evaluate the safety, cell metabolokinetics, and efficacy of CAR-GPC3 T cells infused intravenously at single escalating doses in patients with advanced hepatocellular carcinoma.
Primary objectives:
Secondary objectives:
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 9 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →CARsgen Therapeutics Co., Ltd. is the lead sponsor of 13 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The subjects are enrolled into 2 dose levels cohorts in sequence
Biological: CAR-GPC3 T Cells
CAR-GPC3 T Cells injection
Also known as: Chimeric Antigen Receptor T Cells Targeting Glypican-3
Dose-limiting toxicity (DLT)
Safety
Time frame: After 28 days of single infusion
Maximum tolerated dose (MTD)
tolerability
Time frame: After 28 days of single infusion
Pharmacokinetics (the copies of cells in vivo)
Pharmacokinetics is the"Implantation endpoint" which is defined as the number of copies of CAR-GPC3 DNA in peripheral blood at each visit after infusion until any two consecutive test results are negative or below the detection limit. It aims to calculate the Peak Plasma Concentration (Cmax)
Time frame: Day0~Week 26
Pharmacokinetics ( the duration of survival of cells in vivo)
Duration of CAR-GPC3 T cell persistence is the period from the day of infusion to the first negative test result or result lower than the detection limit.It aims to calculate the area under the plasma concentration versus time curve (AUC)
Time frame: Day0~Week 26
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Adverse events up to 24 months of follow-up visit judged by the investigator to be associated with CAR-GPC3T cell infusion, such as abnormalities or changes in laboratory examinations, physical examinations, vital signs, etc.
Time frame: Month 24
Antitumor efficacy-Progression-free survival (PFS)
The period from the day when the subject receives the infusion of cells to the first recorded tumor progression (whether treated or not) or death of any cause, which occurs first.
Time frame: Month 24
Antitumor efficacy-Duration of response (DOR)
The period from the first evaluation of CR or PR to the first evaluation of PD(Progressive Disease) or death of any cause.
Time frame: Month 24
Antitumor efficacy-Duration of disease control (DDC)
The period from the first evaluation of CR, PR, or SD to the first evaluation of PD or any cause of death.
Time frame: Month 24
Antitumor efficacy-Overall survival (OS)
The period from the first infusion to any cause of death
Time frame: Month 24
Antitumor efficacy-Objective response rate (ORR);
The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%). In the event of PR or CR, the subjects should confirm it no less than 4 weeks after the first evaluation
Time frame: Month 24
Antitumor efficacy-Disease control rate (DCR)
The number of cases in which response (PR + CR) and stable disease (SD) are achieved from the start of cell infusion/the total number of evaluable cases (%).
Time frame: Month 24
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
CARsgen Therapeutics Co., Ltd.