Ignite Creation Date:
2024-05-06 @ 10:01 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03132792
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-08-29
First Post:
2017-04-25
Brief Title:
AFPᶜ³³²T in Advanced HCC
Sponsor:
Adaptimmune
Organization:
Adaptimmune
Study Overview
Official Title:
A Phase I Open Label Clinical Trial Evaluating the Safety and Anti-Tumor Activity of Autologous T Cells Expressing Enhanced TCRs Specific for Alpha Fetoprotein AFPᶜ³³²T in HLA-A2 Positive Subjects With Advanced Hepatocellular Carcinoma HCC or Other AFP Expressing Tumor Types
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
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:
This first time in human study is intended for men and women between 18 and 75 years of age who have advanced liver cancer which has grown or returned after being treated or another AFP expressing tumor Those who did not tolerate or refused other therapies may also participate The purpose of this study is to test the safety of genetically changed T cells that target alpha-fetoprotein AFP and find out what effects if any they have in subjects with liver cancer or other AFP expressing tumor types This study is for subjects who have a blood test positive for appropriate HLA-A02 P Group and have adequate AFP protein in blood or tumor and whose noncancerous liver tissue has very little AFP protein Liver only
The study will take the subjects T cells which are a natural type of immune cell in the blood and send them to a laboratory to be modified The changed T cells used in this study will be the subjects own T cells that have been genetically changed with the aim of attacking and destroying cancer cells
The manufacturing of T cells takes about 1 month to complete The T cells will be given back to the subject through an intravenous infusion after 3 days of chemotherapy The study will evaluate three different cell dose levels in order to find out the target cell dose Once the target cell dose is determined additional subjects will be enrolled to further test the safety and effects at this cell dose
Subjects will be hospitalized for at least 1 week after receiving their T cells back and then seen frequently by the Study Physician for the next 6 months After that subjects will be seen every three months If subjects have disease progression or withdraw from the study they will then be entered into a long-term follow up for safety monitoring In long-term follow up subjects will be seen every 6 months by their Study Physician for the first 5 years after the T cell infusion and annually for the next 10 years
The study will take the subjects T cells which are a natural type of immune cell in the blood and send them to a laboratory to be modified The changed T cells used in this study will be the subjects own T cells that have been genetically changed with the aim of attacking and destroying cancer cells
The manufacturing of T cells takes about 1 month to complete The T cells will be given back to the subject through an intravenous infusion after 3 days of chemotherapy The study will evaluate three different cell dose levels in order to find out the target cell dose Once the target cell dose is determined additional subjects will be enrolled to further test the safety and effects at this cell dose
Subjects will be hospitalized for at least 1 week after receiving their T cells back and then seen frequently by the Study Physician for the next 6 months After that subjects will be seen every three months If subjects have disease progression or withdraw from the study they will then be entered into a long-term follow up for safety monitoring In long-term follow up subjects will be seen every 6 months by their Study Physician for the first 5 years after the T cell infusion and annually for the next 10 years
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None