Ignite Creation Date:
2024-05-06 @ 5:37 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05378464
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2022-05-12
Brief Title:
Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine Pepinemab Trastuzumab in Patients w Metastatic HER2 Breast Cancer
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase 1 Study of Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine and Pepinemab Trastuzumab in Patients With Metastatic HER2-Positive Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test the safety of Adoptive T-Cell therapy following the Dendritic Cell DC1 study vaccine given in combination with pepinemab added to standard of care therapy trastuzumab to help people with HER2 positive breast cancer
Detailed Description:
Patients with HER2-positive HER2 metastatic breast cancer will be treated with 6 weekly injections of dendritic cell DC1 vaccines in combination with trastuzumab and pepinemab
Investigators hypothesize these therapies will elicit CD4 HER2 specific T cell responses HER2 specific T cells will be expanded ex vivo which will be infused to patients subsequently following lymphodepletion therapy with cyclophosphamide Trastuzumab and pepinemab will be given as maintenance in addition to booster DC1 vaccines
Investigators hypothesize these therapies will elicit CD4 HER2 specific T cell responses HER2 specific T cells will be expanded ex vivo which will be infused to patients subsequently following lymphodepletion therapy with cyclophosphamide Trastuzumab and pepinemab will be given as maintenance in addition to booster DC1 vaccines
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