Ignite Creation Date:
2024-05-06 @ 8:59 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02876978
Status:
UNKNOWN
Last Update Posted:
2016-08-24
First Post:
2016-08-09
Brief Title:
Anti-GPC3 CAR T for Recurrent or Refractory Lung Squamous Cell Carcinoma
Sponsor:
CARsgen Therapeutics Co Ltd
Organization:
CARsgen Therapeutics Co Ltd
Study Overview
Official Title:
Preliminary Clinical Study of Autologous T Cells Modified Chimeric Antigen Receptor CAR Targeting GPC3 for the Treatment of Recurrent or Refractory Lung Squamous Cell Carcinoma
Status:
UNKNOWN
Status Verified Date:
2016-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to observe and confirm the safety tolerance and cell pharmacokinetics of lentivirus-transduced CAR-GPC3 T cells CAR-GPC3 T cells targeting GPC3
Detailed Description:
A single-center open-label pilot study to determine the safety tolerance and engraftment potential of CAR-GPC3 T cells in subjects with GPC3 positive lung squamous cell carcinoma
Primary objectives
Observe and determine the safety and tolerance in escalating dose infusion of CAR-GPC3 T cells CAR T cells targeting GPC3 transduced with the lentiviral vector and the survival of the CAT-GPC3 T cells in vivo referred to as engraftment potential
Secondary objectives
The following indexes are monitored for curative effect of CAR-GPC3 T cells on lung squamous cell carcinoma
1 Objective response rate ORR is defined as the ratio of patients diagnosed as partial remission PR to complete remission CR according to RECIST 11 criteria
2 Progression free survival PFS is defined as the duration from baseline to PD audited and confirmed by independent imaging or to the day of any death event The earlier one shall prevail
3 Time to tumor progression TTP is defined as the duration from baseline to disease starts to get worse or spreads to other parts of the body
4 Overall survival OS is defined as the time period from the 1st day of treatment to the day of death for any reason For patients who are still alive at the data analysis day OS data is subject to the last confirmed time of survival patients
Primary objectives
Observe and determine the safety and tolerance in escalating dose infusion of CAR-GPC3 T cells CAR T cells targeting GPC3 transduced with the lentiviral vector and the survival of the CAT-GPC3 T cells in vivo referred to as engraftment potential
Secondary objectives
The following indexes are monitored for curative effect of CAR-GPC3 T cells on lung squamous cell carcinoma
1 Objective response rate ORR is defined as the ratio of patients diagnosed as partial remission PR to complete remission CR according to RECIST 11 criteria
2 Progression free survival PFS is defined as the duration from baseline to PD audited and confirmed by independent imaging or to the day of any death event The earlier one shall prevail
3 Time to tumor progression TTP is defined as the duration from baseline to disease starts to get worse or spreads to other parts of the body
4 Overall survival OS is defined as the time period from the 1st day of treatment to the day of death for any reason For patients who are still alive at the data analysis day OS data is subject to the last confirmed time of survival patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None