Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05881525
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2023-04-11
Brief Title:
NY-ESO-1 TCR-T Cells for NY-ESO-1 Positive Subjects With Advanced Solid Tumors
Sponsor:
TCRCure Biopharma Ltd
Organization:
TCRCure Biopharma Ltd
Study Overview
Official Title:
A Phase III Clinical Study of TC-N201 Injection for the Treatment of Advanced Solid Tumors With HLA-A2 Expression and Positive NY-ESO-1
Status:
RECRUITING
Status Verified Date:
2024-04
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:
New York Esophageal Squamous Cell Carcinoma 1 NY-ESO-1 is a cancer-testis antigen CTA which is expressed in various tumors In TCR-T therapy researchers take the blood of a certain patient select T cells and insert genes into the cell that expressing a kind of protein that targeting NY-ESO-1 The genetically engineered cells are called NY-ESO-1 TCR-T cells Then the engineered cells are re-infused to the cancer patients to cure the disease or prolong life
Detailed Description:
This is a single-center open-label Phase I clinical study of TCR-T cells for the treatment of the recurrentmetastatic solid tumors patients who had failed standard therapy
Objective
To evaluate the safety and efficacy of TCR-T cells for the treatment of advanced solid tumors
Eligibility
Adults aging 18-70 with advanced solid tumors
Design
Patients will undergo screening tests including imaging procedures heart and lung tests and lab tests
Patients will have leukapheresis Blood will be removed through a needle in the arm A machine separates the white blood cells The rest of the blood is returned through a needle in the other arm
Engineered T cells will be re-infused into the patient Patients will stay in hospital and be evaluated
Objective
To evaluate the safety and efficacy of TCR-T cells for the treatment of advanced solid tumors
Eligibility
Adults aging 18-70 with advanced solid tumors
Design
Patients will undergo screening tests including imaging procedures heart and lung tests and lab tests
Patients will have leukapheresis Blood will be removed through a needle in the arm A machine separates the white blood cells The rest of the blood is returned through a needle in the other arm
Engineered T cells will be re-infused into the patient Patients will stay in hospital and be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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