Ignite Creation Date:
2024-05-06 @ 6:52 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05812326
Status:
COMPLETED
Last Update Posted:
2023-04-13
First Post:
2022-10-11
Brief Title:
PD-1 Knockout Anti-MUC1 CAR-T Cells in the Treatment of Advanced Breast Cancer
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
Exploratory Clinical Study of PD-1 Knockout Targeting MUC1 CAR-T Cells AJMUC1 in the Treatment of MUC1-positive Advanced Breast Cancer
Status:
COMPLETED
Status Verified Date:
2022-10
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 exploratory clinical study aims to assess the safety and preliminary efficacy of an immunotherapy using PD-1 knockout anti-MUC1 CAR-T cells in the treatment of advanced MUC1-positive breast cancer
Detailed Description:
This is a single-center open-label dose-escalation exploratory study investigating the safetytolerability and preliminary efficacy of AJMUC1 PD-1 knockout CAR-T cells targeting aberrantly glycosylated MUC1 in the treatment of patients with advanced MUC1 positive breast cancer The primary objective of this study is to evaluate the safety tolerability biological activity and preliminary antitumor efficacy of AJMUC1 The study adopts a 33 dose escalation design to identify the maximum tolerated dose MTD maximum administered dose MAD Three doses are set 3105 CAR T cellskg 1106 CAR T cellskg and 3106 CAR T cellskg with a total of 15 patients planned by the data cutoff date Participants may receive one two three or more cycles of AJMUC1 infusion dependent on the adverse effects and potential clinical benefits This study is initiated by the investigators and approved by the Human Ethics Committee of Sun Yat-sen Memorial Hospital affiliated with Sun Yat-sen University All patients have signed informed consent
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