Chimeric Antigen Receptor T Cells Targeting Glypican-3
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|ClinicalTrials.gov Identifier: NCT03884751|
Recruitment Status : Recruiting
First Posted : March 21, 2019
Last Update Posted : October 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Biological: CAR-GPC3 T Cells||Phase 1|
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.
- To evaluate the safety and tolerability of CAR-GPC3 T cells infused intravenously at escalating doses in patients with advanced hepatocellular carcinoma.
- To evaluate the metabolic kinetics of single infusion of CAR-GPC3 T cells
- To evaluate the overall safety and tolerability of infusion of CAR-GPC3 T cells
- To observe the efficacy of CAR-GPC3 T cells in the treatment of advanced hepatocellular carcinoma
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Clinical Study of Chimeric Antigen Receptor T Cells Targeting Glypican-3 (CAR-GPC3 T Cells) in Patients With Advanced Hepatocellular Carcinoma|
|Actual Study Start Date :||August 15, 2019|
|Estimated Primary Completion Date :||August 22, 2021|
|Estimated Study Completion Date :||May 24, 2024|
Experimental: CAR-GPC3 T Cells
The subjects are enrolled into 2 dose levels cohorts in sequence
Biological: CAR-GPC3 T Cells
CAR-GPC3 T Cells injection
Other Name: Chimeric Antigen Receptor T Cells Targeting Glypican-3
- Dose-limiting toxicity (DLT) [ Time Frame: After 28 days of single infusion ]Safety
- Maximum tolerated dose (MTD) [ Time Frame: After 28 days of single infusion ]tolerability
- Pharmacokinetics (the copies of cells in vivo) [ Time Frame: Day0~Week 26 ]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)
- Pharmacokinetics ( the duration of survival of cells in vivo) [ Time Frame: Day0~Week 26 ]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)
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: Month 24 ]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.
- Antitumor efficacy-Progression-free survival (PFS) [ Time Frame: Month 24 ]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.
- Antitumor efficacy-Duration of response (DOR) [ Time Frame: Month 24 ]The period from the first evaluation of CR or PR to the first evaluation of PD(Progressive Disease) or death of any cause.
- Antitumor efficacy-Duration of disease control (DDC) [ Time Frame: Month 24 ]The period from the first evaluation of CR, PR, or SD to the first evaluation of PD or any cause of death.
- Antitumor efficacy-Overall survival (OS) [ Time Frame: Month 24 ]The period from the first infusion to any cause of death
- Antitumor efficacy-Objective response rate (ORR); [ Time Frame: Month 24 ]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
- Antitumor efficacy-Disease control rate (DCR) [ Time Frame: Month 24 ]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 (%).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03884751
|Contact: Li zonghai, MDemail@example.com|
|Contact: Zhang firstname.lastname@example.org|
|The 81st Hospital of Chinese PLA||Not yet recruiting|
|Nanjing, Jiangsu, China, 210002|
|Contact: shukui qin, prof. 025-80864541 email@example.com|
|Renji Hospital Shang Hai Jiaotong Unversity of Medicine||Not yet recruiting|
|Shanghai, Shanghai, China, 200001|
|Contact: liwei wang, MD 021-68383134 Lwwang2013@163.com|
|Principal Investigator: bo zhai, MD|
|The First Affiliated Hospital Zhejiang University||Recruiting|
|Hangzhou, Zhejiang, China, 310006|
|Contact: weijia fang, MD 0571-87236560 firstname.lastname@example.org|
|Principal Investigator:||Qin shukui, Pro||The 81st Hospital of PLA|
|Principal Investigator:||Zhai bo, Pro||RenJi Hospital|